Society for Clinical Trials

SCT Annual Meeting Presentations & Videos
* Note that only Keynote Lectures and Trial of the Year are available to non-members for 2022 and 2023.
Members can login to view all presentations from recent years.

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3190 Learning Opportunities Found

Primary Presenter

Presentation Information

Media Type(s)

Merit Cudkowicz
2024 (Boston) Annual Meeting

Curtis Meinert Lecture
Advances in Neurotherapeutics Updates on ALS and NeuroNEXT

Penney Cowan
2024 (Boston) Annual Meeting

Founders Lecture
Perspective of Those With Lived Experience: Involving a Patient in Clinical Trials

Adam Devall
2024 (Boston) Annual Meeting

Trial of the Year Award
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage

Alan T. Tita
2023 (Baltimore) Annual Meeting

Trial of the Year Award
The Chronic Hypertension and Pregnancy Treatment Trial (CHAP)

Kirsten Bibbins-Domingo
2023 (Baltimore) Annual Meeting

Founders Lecture
Medical Publishing in Dynamic Times: A View from JAMA and the JAMA Network

John P.A. Ioannidis
2023 (Baltimore) Annual Meeting

Curtis Meinert Lecture
Meta-epidemiology of evidence from clinical trials

Dong-Yun Kim
2022 (San Diego) Annual Meeting

Session Proposal
All for One, One for All: How to Run Multiple Networks of COVID-19 Clinical Trials on a Common Platform Using Bayesian Method

Session Details

Susan Ellenberg
2022 (San Diego) Annual Meeting

Session Proposal
Clinical Trials of COVID-19 Vaccines: Overcoming the Challenges

Session Details

Min Zhan
2022 (San Diego) Annual Meeting

Contributed Session
Analysis of Adverse Event and Serious Adverse Event Data from Randomized Controlled Trials

Session Details

Riaz Qureshi
2022 (San Diego) Annual Meeting

Contributed Session
Data Visualization Approaches to Presenting Harms in Clinical Trials

Session Details

Marie Kay
2022 (San Diego) Annual Meeting

Contributed Session
Assessment of a Risk-Based Quality Management Approach to Protocol Deviations - A Data Coordinating Center's Experience

Session Details

Eric Fischer
2022 (San Diego) Annual Meeting

Contributed Session
Dynamically Generating Study Monitoring Reports via Email

Session Details

J Athene Lane
2022 (San Diego) Annual Meeting

Contributed Session
Virtual Clinical Outcome Ascertainment in a Prostate Cancer Treatment Trial

Session Details

Kelly Karavolos
2022 (San Diego) Annual Meeting

Contributed Session
Challenges of Data Collection for a Fully Remote Clinical Trial with a Multi-Component Outcome: Virtual ELM Pilot Study

Session Details

Rebecca Metcalfe
2022 (San Diego) Annual Meeting

Contributed Session
Integrating Patient Values into Clinical Trials Using a Patient-Centered Composite Endpoint: A Case Study Using the Control of Hypertension in Pregnancy Study (CHIPS) Trial

Session Details

BeiBei Guo
2022 (San Diego) Annual Meeting

Contributed Session
A Biomarker-Based Dose-Finding Design for Immunotherapy

Session Details

Yunshan Duan
2022 (San Diego) Annual Meeting

Contributed Session
A Unified Decision Framework for Phase I Dose-Finding Designs

Session Details

Hakim-Moulay Dehbi
2022 (San Diego) Annual Meeting

Contributed Session
Early Phase Dose-Finding Trials in Virology

Session Details

Evan Bagley
2022 (San Diego) Annual Meeting

Contributed Session
Dose-Finding Based on Feasibility and Late-Onset Toxicity in Adoptive Cell Therapy Trials

Session Details

Jack Wolf
2022 (San Diego) Annual Meeting

Contributed Session
A Permutation Procedure to Detect Heterogeneous Treatments Effects in Randomized Clinical Trials While Controlling the Type-I Error Rate

Session Details

Peter Godolphin
2022 (San Diego) Annual Meeting

Contributed Session
Estimating Interactions and Subgroup-Specific Treatment Effects in Meta-Analysis Without Aggregation Bias: A Within-Trial Framework

Session Details

Jiyang Wen
2022 (San Diego) Annual Meeting

Contributed Session
Simultaneous Hypothesis Testing for Multiple Competing Risks in Comparative Clinical Trials

Session Details

Andrea Viecelli
2022 (San Diego) Annual Meeting

Contributed Session
Enhancing Patient-Partnership in Clinical Trials

Session Details

Mithat Gönen
2022 (San Diego) Annual Meeting

Special Presentation
Annual Business Meeting 2022

Chalmers & Green Award Presentations
2022 (San Diego) Annual Meeting

Award Presentation
Andrea Viecelli, Jiyang Wen, Peter Godolphin, Jack Wolf

Class of 2022 Fellows
2022 (San Diego) Annual Meeting

Fellows Presentation
Thomas Cook & Alexia Iasonos

Drs. Edward Mills & Gilmar Reis
2022 (San Diego) Annual Meeting

Trial of the Year Award
The TOGETHER Trial: An Adaptive Platform International Trial

Dr. Robert Califf, FDA Commissioner
2022 (San Diego) Annual Meeting

Founders Lecture
The Time is Now to Fix the Evidence Generation System

Mithat Gönen
2022 (San Diego) Annual Meeting

Presidential Welcome

Dr. Worta McCaskill-Stevens
2022 (San Diego) Annual Meeting

Curtis Meinert Lecture
Lessons Learned From the National Cancer Institute's Community Based Clinical Trials

Arsenio Paez
2022 (San Diego) Annual Meeting

Contributed Session
The Effects of Preceding Prospective Collaborative Studies (IDEAL Stage 2b) on the Quality and Impact of Subsequent Randomized Controlled Trials (IDEAL Stage 3) Evaluating Surgical Innovations: A Systematic Review and Case-Control Study

Session Details

Annabelle South
2022 (San Diego) Annual Meeting

Contributed Session
Communicating Overall Results to Trial Participants: The Perspective of Site Staff from the Show RESPECT Study

Session Details

Christin Hoffmann
2022 (San Diego) Annual Meeting

Contributed Session
A Core Information Set to Guide Early Phase Surgical Research

Session Details

Annabelle South
2022 (San Diego) Annual Meeting

Contributed Session
Effectiveness of Interventions to Share Trial Results with Health Workers and Policymakers: Results of a Systematic Review

Session Details

Zhibao Mi
2022 (San Diego) Annual Meeting

Contributed Session
Statistical Assessment of Unplanned Crossover Effect in Surgical Trials

Session Details

Jun Yin
2022 (San Diego) Annual Meeting

Contributed Session
Multi-Arm Multi-Outcome Clinical Trial Design and Analysis with Bayesian Spike-and-Slab Priors

Session Details

Daniel Schwartz
2022 (San Diego) Annual Meeting

Contributed Session
Dynamic Borrowing from Historical Controls via the Synthetic Prior with Covariates in Randomized Clinical Trials

Session Details

Samuel Sarkodie
2022 (San Diego) Annual Meeting

Contributed Session
A Hybrid Approach to Comparing Parallel-Group and Stepped-Wedge Cluster Randomized Trials When There is Uncertainty in the Intra-Cluster Correlation

Session Details

Clement Ma
2022 (San Diego) Annual Meeting

Contributed Session
Landscape of Phase 2 Trials in Alzheimer’s Disease: A Systematic Review of Trial Characteristics

Session Details

Christin Hoffmann
2022 (San Diego) Annual Meeting

Contributed Session
Modifications to Surgical Procedures: A Scoping Review and Preliminary Framework to Promote Transparent Reporting and Efficient Sharing

Session Details

Chengwu Yang
2022 (San Diego) Annual Meeting

Contributed Session
The CREID: Complementary Randomized Controlled Trial and Real-World Study for Efficacy, Effectiveness, and Implementation Design, with Illustrations of One Published and Two Proposed Large Studies for Sequential and Parallel Designs

Session Details

Mark Harrison
2022 (San Diego) Annual Meeting

Contributed Session
Involving Patients in the Design of Randomized Clinical Trials

Session Details

Caitlin Thomas
2022 (San Diego) Annual Meeting

Contributed Session
Predicting Patients’ Willingness to Participate in Clinical Trials: A Simulation Tool Using Patient Choice Data

Session Details

Yun Qing
2022 (San Diego) Annual Meeting

Contributed Session
A Bayesian Piecewise Exponential Phase II Design for Monitoring a Time-to-Event Endpoint

Session Details

Yongming Qu
2022 (San Diego) Annual Meeting

Contributed Session
Collection of Precise Reasons for Treatment Discontinuations to Allow Better Defining Estimands

Session Details

Mayumi Fukuda-Doi
2022 (San Diego) Annual Meeting

Contributed Session
Developing At-A-Glance Workflows for Conducting Trials in Compliance with Complex Regulatory Systems and Expectations for Simplification of the System in Japan

Session Details

Hongli Li
2022 (San Diego) Annual Meeting

Contributed Session
A Non-Factorial Analysis of a Factorial Phase II Trial Design to Evaluate Single Agent and Combination Consolidation Therapies Following CD19 CAR T-cell Therapy for Relapsed/Refractory Diffuse Large B cell Lymphoma (R/R DLBCL): SWOG-S2114

Session Details

Fei Yuan
2022 (San Diego) Annual Meeting

Contributed Session
Stopping Rules of Interim Monitoring Analyses in Clinical Trials

Session Details

Christin Hoffmann
2022 (San Diego) Annual Meeting

Contributed Session
Automated Real-Time Monitoring and Feedback of Shared Decision Making for Surgery: A Non-Randomised Feasibility Study

Session Details

Fernando Santos Sanchez
2022 (San Diego) Annual Meeting

Contributed Session
A Novel Approach Employing Readability Metrics and Crowdsourcing to Improve Randomised Clinical Trial Information Leaflets

Session Details

Yongxi Long
2022 (San Diego) Annual Meeting

Contributed Session
A Bayesian Exact Adaptive Platform Design with Continual Reassessment for Trials Utilizing Real World Data

Session Details

Oleksandr Savenkov
2022 (San Diego) Annual Meeting

Contributed Session
A Comprehensive Simulation Study to Compare Estimators of Restricted Mean Survival Time Using Data from Clinical Trials

Session Details

Cristina Murray-Krezan
2022 (San Diego) Annual Meeting

Contributed Session
A Culturally and Contextually Situated Multimedia Approach to Recruiting, Consenting, and Randomizing a Hard-to-Reach Spanish-Speaking Population for a Randomized Controlled Trial

Session Details

Chris Cook
2022 (San Diego) Annual Meeting

Contributed Session
A More Efficient Approach to Clinical Trial Data Collection: The SWOG-nCartes Pilot Collaboration

Session Details

Gabrielle Murashova
2022 (San Diego) Annual Meeting

Session Proposal
A Partnership between Clinical Safety and Statistics for Aggregate Safety Assessment –Year Two

Session Details

Letitia Perdue
2022 (San Diego) Annual Meeting

Session Proposal
A Pragmatic Path to Direct Delivery of Drug to Participants

Session Details

Sasha Kravets
2022 (San Diego) Annual Meeting

Contributed Session
A RSHINY APPLET for Sequential, Multiple Assignment, Randomized Trials with a Time-to-Event Final Endpoint

Session Details

Ying Zhang
2022 (San Diego) Annual Meeting

Contributed Session
A SAS Macro for the Power of Generalized Estimating Equations Analysis of Cluster Randomized Trials with the Application to Stepped Wedge Designs

Session Details

Evan Kwiatkowski
2022 (San Diego) Annual Meeting

Contributed Session
A Structured Framework for Adaptively Incorporating External Evidence in Sequentially Monitored Clinical Trials

Session Details

Zhuopei Hu
2022 (San Diego) Annual Meeting

Contributed Session
A Web Application Tool for Power Calculation of Stepped Wedge Cluster Randomization Trials with Complete/Incomplete Design

Session Details

Kimberly Carlson
2022 (San Diego) Annual Meeting

Session Proposal
Accommodating “History Effects” in Long Duration, Multi-Site Clinical Trials to Ensure Relevant and Compelling Evidence

Session Details

Shun Fu Lee
2022 (San Diego) Annual Meeting

Contributed Session
Accounting for Correlation Among the Total Events of Composite Outcomes in Cardiovascular Trials

Session Details

Richard Emsley
2022 (San Diego) Annual Meeting

Contributed Session
Accounting for Differential Uptake of Treatment-as-Usual in Open-Label RCTs: A Comparison of Methods and Illustration in Mental Health Trials

Session Details

Guangyu Tong
2022 (San Diego) Annual Meeting

Contributed Session
Accounting for Unequal Cluster Sizes in Designing Cluster Randomized Trials to Detect Treatment Effect Heterogeneity

Session Details

Marcus Johnson
2022 (San Diego) Annual Meeting

Contributed Session
Addressing Challenges and Barriers to Rural Veteran Participation in Clinical Research Within the Veterans Affairs Healthcare System

Session Details

Richard Henry
2022 (San Diego) Annual Meeting

Contributed Session
Advantages, Disadvantages, and Other Considerations for Trials in Cohorts: A Decade In

Session Details

David Zahrieh
2022 (San Diego) Annual Meeting

Contributed Session
Allowing for Uncertainty in the Components Required for Sample Size Estimation for a Cluster Randomized Trial Using the Symbolic Two-Step Method

Session Details

Richard Emsley
2022 (San Diego) Annual Meeting

Session Proposal
Analysing Clinical Trials Disrupted by the COVID-19 Pandemic

Session Details

Lu Mao
2022 (San Diego) Annual Meeting

Session Proposal
Analysis of Complex Time-to-Event Endpoints in Clinical Trials

Session Details

Tyler Bonnett
2022 (San Diego) Annual Meeting

Session Proposal
Bad Bugs in Tough Places – Developing Capacity to Obtain Compelling Evidence in Challenging Environments

Session Details

Travis Lilley
2022 (San Diego) Annual Meeting

Contributed Session
Bayesian Analysis of Cluster Randomized Trials with Ordinal Endpoints

Session Details

Fang Fang
2022 (San Diego) Annual Meeting

Contributed Session
Bayesian Methods to Compare Dose Levels to Placebo in a small n, Sequential, Multiple Assignment, Randomized Trial (snSMART) with a Continuous Outcome

Session Details

Azzolina Danila
2022 (San Diego) Annual Meeting

Contributed Session
Bayesian Network Enforced Super Learner Treatment Effect Estimation in Clinical Trial: A Proposal and Application

Session Details

Lianlian Du
2022 (San Diego) Annual Meeting

Contributed Session
Bayesian Random Change Point Mixed Model Analysis of Cognitive Performance Trajectories to Identify Eligible Patients for Randomized Clinical Trials

Session Details

Anda Dragomir
2022 (San Diego) Annual Meeting

Educational Session
Behavioural Trial Design: Using Stakeholder-Driven Processes to Develop Interventions and Assessment Tools Using a Public Health Intervention Example

Session Details

Menelaos Konstantinidis
2022 (San Diego) Annual Meeting

Contributed Session
Benefits and Pitfalls of Combining Observational and Experimental Studies in Network Meta-Analyses: Implications for Public Health Policy

Session Details

Paola Berchialla
2022 (San Diego) Annual Meeting

Contributed Session
Benefits and Risks in Leveraging Historical Control Data in Clinical Trials

Session Details

Ileana Baldi
2022 (San Diego) Annual Meeting

Contributed Session
Building Infrastructure to Exploit Evidence from Patient Preference Information (PPI) Studies

Session Details

Chuck Huber
2022 (San Diego) Annual Meeting

Educational Session
Causal Inference for Complex Data

Session Details

Danielle Edwards
2022 (San Diego) Annual Meeting

Contributed Session
Challenges for Conducting Mediation Analyses in Multi-Arm Trials

Session Details

Elizabeth Avery
2022 (San Diego) Annual Meeting

Contributed Session
Challenges Implementing a Clustered Randomized Behavioral Clinical Trial in a Community Based Participatory Research Framework

Session Details

Kevin Buhr
2022 (San Diego) Annual Meeting

Educational Session
Clinical Trial Data Monitoring Committees and Reporting Statistical Centers: The Basics and Emerging Issues

Session Details

Marcus Johnson
2022 (San Diego) Annual Meeting

Contributed Session
Clinical Trial Facilitators: A Novel Approach to Support the Execution of Clinical Research at the Study Site Level

Session Details

Wendy Seiferheld
2022 (San Diego) Annual Meeting

Contributed Session
ClinicalTrials.gov Tracking with Do-It-Yourself Application Programming Interface (DIY API)

Session Details

Anca Chis Ster
2022 (San Diego) Annual Meeting

Contributed Session
Combining Non-Adherence and Mediation in a Unified Causal Analysis: A Methodological Review and Application to the AVATAR Trial

Session Details

Heng Zhou
2022 (San Diego) Annual Meeting

Session Proposal
Complex Innovative Design in the Modern Drug Development Era

Session Details

Victoria Shepherd
2022 (San Diego) Annual Meeting

Contributed Session
Conceptualising ‘Good’ Proxy Consent Decisions for Clinical Trial Participation: Implications for the Development of Interventions to Improve the Quality of Proxy Consent

Session Details

Hayley Belli
2022 (San Diego) Annual Meeting

Contributed Session
Considerations When Collecting Real World Data in Expanded Access Programs

Session Details

Christina Bucci-Rechtweg
2022 (San Diego) Annual Meeting

Contributed Session
Correcting Disparities In Adolescent Access To Medicines By Promoting Age-Inclusive Research

Session Details

Andrew Hall
2022 (San Diego) Annual Meeting

Contributed Session
Decision making under uncertainty in PI-II dose finding trials in Oncology

Session Details

Jody Ciolino
2022 (San Diego) Annual Meeting

Educational Session
Demystifying Statistics in Clinical Trials

Session Details

Fan Li
2022 (San Diego) Annual Meeting

Session Proposal
Design and Analysis of Stepped Wedge Cluster Randomized Trials Based on Marginal Models for Discrete and Continuous Outcomes

Session Details

Sheng luo
2022 (San Diego) Annual Meeting

Educational Session
Design Clinical Trials with Non-Inferiority Hypothesis: Methods and Applications

Session Details

Jonathan Beall
2022 (San Diego) Annual Meeting

Session Proposal
Developing Adaptive Trial Designs: A Collaborative Process Balancing Statistical Efficiency with Clinical Importance

Session Details

Harry Parr
2022 (San Diego) Annual Meeting

Contributed Session
Developing and Externally Validating Clinical Dynamic Prediction Joint Models for Localised Prostate Cancer

Session Details

Victoria Shepherd
2022 (San Diego) Annual Meeting

Contributed Session
Development of a Core Outcome Set for the Evaluation of Interventions to Enhance Proxy Consent Decisions on Behalf of Adults who Lack Capacity to Consent: A Mixed Methods Study (COnSiDER Study)

Session Details

Mat Makowski
2022 (San Diego) Annual Meeting

Contributed Session
Disseminating Phase I Vaccine Trial Data in a Pandemic to Inform the Scientific Community – mRNA-1273 Phase I Trials

Session Details

Shawn Hirsch
2022 (San Diego) Annual Meeting

Contributed Session
Do Participants Exhibit Evidence of Respondent Fatigue After Completion of Subjective Questionnaires Multiple Times Across a Study?: Examination of Data from a Phase I Inpatient Randomized Clinical Trial

Session Details

Kentaro Takeda
2022 (San Diego) Annual Meeting

Session Proposal
Dose Optimization in Oncology: Why, When and How

Session Details

Lauren Shirley
2022 (San Diego) Annual Meeting

Contributed Session
Dotting Your I's and Crossing Your T's: An Informed Consent Documentation Tool for Clinical Trials

Session Details

Yves Rosenberg
2022 (San Diego) Annual Meeting

Educational Session
Essentials of Clinical Trials

Session Details

Chia-Rui (Jerry) Chang
2022 (San Diego) Annual Meeting

Contributed Session
Estimating Marginal Treatment Effect in Cluster Randomized Trials with Multilevel Missing Outcomes

Session Details

Wenjing Meng
2022 (San Diego) Annual Meeting

Contributed Session
Estimating the Impact of Patient Preference in Two-Stage Clinical Trials for Binary Outcomes When Some Patients are Indifferent to Treatment

Session Details

Richard Emsley
2022 (San Diego) Annual Meeting

Contributed Session
Estimation of personalised treatment recommendations in the survival context using a restricted mean survival time outcome

Session Details

Emily Roberts
2022 (San Diego) Annual Meeting

Contributed Session
Evaluating Intermediate Clinical Endpoints for Futility Analysis in Clinical Trials

Session Details

Christina Bucci-Rechtweg
2022 (San Diego) Annual Meeting

Contributed Session
Grownish: How And When To Include Adolescents In Adult Research

Session Details

Katie Mellor
2022 (San Diego) Annual Meeting

Contributed Session
How are Progression Decisions Made Following External Randomised Pilot Trials? A Qualitative Interview Study and Framework Analysis

Session Details

Peyton Kline
2022 (San Diego) Annual Meeting

Session Proposal
How Different Communication Pathways Impact the Success of a Clinical Trial, A Multifaceted Perspective

Session Details

Nick Beckley-Hoelscher
2022 (San Diego) Annual Meeting

Contributed Session
How Much is that Data in the Window? A Comparison of Strategies for Analysing Data Recorded Outside Pre-Specified Visit Windows in Randomised Controlled Trials

Session Details

Lisa Eckstein
2022 (San Diego) Annual Meeting

Contributed Session
Identifying and Examining Ethical Considerations Facing Data Monitoring Committees

Session Details

Minji Lee
2022 (San Diego) Annual Meeting

Contributed Session
Identifying Meaningful Change on PROMIS Short Forms in Cancer Patients: A Comparison of Item Response Theory and Classic Test Theory Frameworks

Session Details

Adam Resnick
2022 (San Diego) Annual Meeting

Contributed Session
Implementation of Platform-Enabled Fast Healthcare Interoperability Resources on Behalf of Empowered, Accelerated Discovery in Children with SARS-CoV-2 Infections

Session Details

Heidi Krause-Steinrauf
2022 (San Diego) Annual Meeting

Contributed Session
Implementation of Substudies in Multi-Center Clinical Trials: The Grade Study Experience

Session Details

Danielle Edwards
2022 (San Diego) Annual Meeting

Contributed Session
Implementing Personalised Treatment Recommendations to Determine Optimal Treatment Decisions Using Data from a Three-Arm Trial When Both Active Treatments Show Positive Results

Session Details

Emily Dressler
2022 (San Diego) Annual Meeting

Session Proposal
Improving Data Quality in Multi-Center Trials: Innovative Approaches Utilized within the Wake Forest NCI Community Oncology Research Program Research Base (WF NCORP RB)

Session Details

Michael Rosenblum
2022 (San Diego) Annual Meeting

Educational Session
Improving Precision and Power in Randomized Trials by Leveraging Baseline Variables

Session Details

Katie Mellor
2022 (San Diego) Annual Meeting

Contributed Session
Inclusion of Progression Criteria in External Randomised Pilot Trial Funding Applications Submitted to UK NIHR Research for Patient Benefit

Session Details

Allyn Bove
2022 (San Diego) Annual Meeting

Session Proposal
Inclusive Recruitment Strategies in Clinical Trials: Insights from Rehabilitation Research

Session Details

Emine Bayman
2022 (San Diego) Annual Meeting

Contributed Session
Increasing the Generalizability of Pain Study Results

Session Details

Kathryn Hefner
2022 (San Diego) Annual Meeting

Session Proposal
Innovative Approaches to Data Collection Needs in Clinical Trials: Considerations, Lessons Learned and Future Directions

Session Details

Julie Croft
2022 (San Diego) Annual Meeting

Contributed Session
Integration of Qualitative Research Into Surgical Trials to Optimise Trial Conduct and Understanding of the Trial Results For Maximal Impact

Session Details

Anna Bosse
2022 (San Diego) Annual Meeting

Contributed Session
Interim Data Communication Strategies for Adaptive Clinical Trial Designs

Session Details

Jonathan Beall
2022 (San Diego) Annual Meeting

Contributed Session
Interpreting a Bayesian Phase II Futility Clinical Trial

Session Details

Abigail Baldridge
2022 (San Diego) Annual Meeting

Educational Session
Introduction to Efficient Preparation, Access, and Sharing of Trial Data in REDCap Using the API

Session Details

Laura Lovato
2022 (San Diego) Annual Meeting

Educational Session
It Takes a Village: Multi-Disciplinary Approach to Designing Stellar Data Collection Forms

Session Details

Kathryn Arnold
2022 (San Diego) Annual Meeting

Contributed Session
Lessons from Implementing Practice-Level Cluster Randomized Studies within the NCORP Setting

Session Details

Danielle Cunio
2022 (San Diego) Annual Meeting

Contributed Session
Letter Tracking System Design: The Systolic Blood Pressure Intervention Trial Mind 2020

Session Details

Katelyn Garcia
2022 (San Diego) Annual Meeting

Contributed Session
Lifestyle Intervention Delivery During the COVID Era

Session Details

Wei Wei
2022 (San Diego) Annual Meeting

Contributed Session
Local Multisource-Exchangeability Model for Adaptive Information Borrowing from Multiple Historical Controls

Session Details

Mary Ryan
2022 (San Diego) Annual Meeting

Contributed Session
Maximin Optimal Cluster Randomized Designs Accounting for Treatment Effect Heterogeneity

Session Details

Ying Yuan
2022 (San Diego) Annual Meeting

Educational Session
Model-Assisted Designs: Make Adaptive Clinical Trials Easy and Accessible

Session Details

Aditya Pabba
2022 (San Diego) Annual Meeting

Contributed Session
Novel Method of Using JavaScript Encoding and QR (Quick Response) Codes in Remotely Managed Randomization of Blinded Studies in Low-Resource Environments

Session Details

Eleanor McFadden
2022 (San Diego) Annual Meeting

Contributed Session
OlympiA – A Complex but Successful Model for a Large Global Trial

Session Details

Bingkai Wang
2022 (San Diego) Annual Meeting

Contributed Session
On the Robustness and Precision of Mixed-Model Analysis of Covariance in Cluster-Randomized Trials

Session Details

Shaun Bulsara
2022 (San Diego) Annual Meeting

Contributed Session
OnCore and REDCap: A Comparison of Two Data Management Systems

Session Details

Brian Neumann
2022 (San Diego) Annual Meeting

Contributed Session
One Line on a Manuscript: Operationalizing Ecological Momentary Assessment (EMA) in Clinical Trials

Session Details

Andrea Arfe
2022 (San Diego) Annual Meeting

Contributed Session
Optimality of Testing Procedures for Survival Data in the Non-Proportional Hazards Setting

Session Details

Brigitte Voisard
2022 (San Diego) Annual Meeting

Contributed Session
Optimization of a Training Program in Motivational Communication: Phase 1

Session Details

Pam Mangat
2022 (San Diego) Annual Meeting

Session Proposal
Optimizing Precision Medicine Cancer Clinical Trials

Session Details

Roger Lewis
2022 (San Diego) Annual Meeting

Session Proposal
Optimizing the Interdisciplinary Design of Adaptive Platform Trials

Session Details

Audinga-Dea Hazewinkel
2022 (San Diego) Annual Meeting

Contributed Session
Outcome Variance After Dropout as an Indicator of Missing-Not-At-Random Bias in Randomized Clinical Trials

Session Details

Rachelle Swann
2022 (San Diego) Annual Meeting

Contributed Session
Overview of CDER BIMO Compliance and Enforcement

Session Details

Daisy Gaunt
2022 (San Diego) Annual Meeting

Contributed Session
Participant Retention in Pediatric Randomized Controlled Trials: Systematic Review and Meta-Analysis

Session Details

Hayley Belli
2022 (San Diego) Annual Meeting

Session Proposal
Perspectives on Real World Data and Evidence Collection Through Expanded Access

Session Details

Yisheng Li
2022 (San Diego) Annual Meeting

Session Proposal
Pharmacokinetics and/or Pharmacodynamics-Informed Dose-Finding Designs

Session Details

Jane Hongyuan Zhang
2022 (San Diego) Annual Meeting

Session Proposal
Planning, Prioritizing, and Conducting Clinical Research in the VA Learning Healthcare System During the COVID-19 Pandemic

Session Details

Kendra Plourde
2022 (San Diego) Annual Meeting

Contributed Session
Power Analysis for Stepped Wedge Cluster Randomized Trials with Continuous Co-Primary Endpoints

Session Details

Navneet Hakhu
2022 (San Diego) Annual Meeting

Contributed Session
Quantifying the Impact of Enrichment in Pre-Post Randomized Controlled Clinical Trials

Session Details

Azzolina Danila
2022 (San Diego) Annual Meeting

Contributed Session
Quantifying the Prior Informativeness via ESS Approach in a Clinical Trial: An Application of a Semiparametric Prior Elicitation Phase IIA Design

Session Details

Jason Haukoos
2022 (San Diego) Annual Meeting

Contributed Session
Randomization Schemes Using Electronic Health Systems to Facilitate Emergency Department-Based Pragmatic Clinical Trials of Public Health Screening Interventions

Session Details

Christina Saunders
2022 (San Diego) Annual Meeting

Session Proposal
Real World Experience in Conducting Adaptive Platform Trials

Session Details

Daisy Gaunt
2022 (San Diego) Annual Meeting

Contributed Session
Retention to pediatric randomized controlled trials during the COVID-19 pandemic: a qualitative study

Session Details

Laura Levit
2022 (San Diego) Annual Meeting

Session Proposal
Rethinking the Inclusion of Research Biopsies in the Design of Clinical Trials

Session Details

Songthip Ounpraseuth
2022 (San Diego) Annual Meeting

Contributed Session
Statistical Considerations for Testing Facility Interventions in Infants with Neonatal Opioid Withdrawal Syndrome (NOWS)

Session Details

Katie Gillies
2022 (San Diego) Annual Meeting

Contributed Session
Strategies to Improve Retention in Randomised Trials: A Cochrane Review

Session Details

Heidi Krause-Steinrauf
2022 (San Diego) Annual Meeting

Session Proposal
Strategies to Mitigate the Impact of the COVID Pandemic on Trial Implementation, Closeout, Data Quality and Analysis of a Large Multicenter Clinical Trial: The Glycemia Reduction Approaches in Diabetes Comparative Effectiveness Study (GRADE)

Session Details

Azzolina Danila
2022 (San Diego) Annual Meeting

Contributed Session
SuperLearner Enforced Treatment Effect Estimation in Pediatric Trials

Session Details

Cherish Boxall
2022 (San Diego) Annual Meeting

Contributed Session
SWAT Priorities to Improve the Evidence to Inform Recruitment and Retention Practice in Clinical Trials

Session Details

Jieling Miao
2022 (San Diego) Annual Meeting

Contributed Session
The Application of ACCEPT Software in Retrospective Analysis of Specimen Data (SWOG S0500 Translational Medicine Project)

Session Details

Kim May Lee
2022 (San Diego) Annual Meeting

Contributed Session
The Benefits of Covariate Adjustment for Adaptive Multi-Arm Designs

Session Details

David Bryde
2022 (San Diego) Annual Meeting

Contributed Session
The CURED Framework: A Data-Driven Management Tool to Aid Successful Delivery of Clinical Research Projects

Session Details

Corinne McGill
2022 (San Diego) Annual Meeting

Contributed Session
The Effect of Subject Accrual on Futility Analyses in Randomized Clinical Trials with Time-To-Event Endpoints: A Simulation Study on Conditional Power

Session Details

Xiangrong Kong
2022 (San Diego) Annual Meeting

Session Proposal
The Estimand Framework from the ICH E9(R1) Statistical Principles for Clinical Trials Addendum: Current Implementation Status and Looking Forward

Session Details

Mollie Payne
2022 (San Diego) Annual Meeting

Contributed Session
The Good, The Bad and The Hidden Bias in Mediation Analyses of Clinical Trials

Session Details

Ellen Kingsley
2022 (San Diego) Annual Meeting

Contributed Session
The I-SOCIALISE Study: A Cluster Randomised Controlled Trial Investigating the Social Competence and Isolation of Children with Autism Taking Participating in LEGO® Based Therapy (‘Play Brick Therapy’) Groups in Mainstream School Environments

Session Details

Joseph Rausch
2022 (San Diego) Annual Meeting

Contributed Session
The Inclusion of Covariates in Constrained Longitudinal Data Analysis for Pre-Post Randomized Clinical Trials

Session Details

John Nichols
2022 (San Diego) Annual Meeting

Contributed Session
The Intervention Portal: Consolidating Study Intervention Tracking with Participant Data Management

Session Details

Larisa Tereshchenko
2022 (San Diego) Annual Meeting

Educational Session
The Legacy of Tuskegee and Ethics of Clinical Trials

Session Details

Cory Goldstein
2022 (San Diego) Annual Meeting

Contributed Session
The Problem of Identifying Vulnerable Research Participants in Pragmatic Cluster Randomized Trials

Session Details

Cody Chiuzan
2022 (San Diego) Annual Meeting

Session Proposal
The Promise and Challenges of Integrating Real-World Evidence in Clinical Research

Session Details

Julia Collins
2022 (San Diego) Annual Meeting

Contributed Session
The Protocol Review Checklist: A Tool to Ensure Protocol Completeness, Consistency, and Accuracy

Session Details

Yi Dai
2022 (San Diego) Annual Meeting

Contributed Session
The Use of Evidence-Based Dynamic Treatment Regimes to Improve Depression Outcomes

Session Details

Katie Gillies
2022 (San Diego) Annual Meeting

Contributed Session
The What, How, When and Who of Sharing Trial Results Summaries with Trial Participants: Stakeholder Informed Guidance from the RECAP Project

Session Details

Dario Gregori
2022 (San Diego) Annual Meeting

Contributed Session
The Win-Ratio Approach. Some Notes on the Impact of Unbalanced Samples, Heterogeneity, and Clustering in Data

Session Details

Neil Corrigan
2022 (San Diego) Annual Meeting

Contributed Session
Trial Designs to Target the Conditional Average Treatment Effect, with Application to Operating Surgeon Learning Effects in Surgical RCTS

Session Details

Lawrence Mbuagbaw
2022 (San Diego) Annual Meeting

Educational Session
TrialTree: A Novel Application for Interactive Trial Design

Session Details

Jose Luis Olmos- Serrano
2022 (San Diego) Annual Meeting

Contributed Session
TwinRCT: Leveraging External Data, Artificial Intelligence, and Covariate Adjustment

Session Details

Victoria Shepherd
2022 (San Diego) Annual Meeting

Contributed Session
Unpacking the ‘Black Box of Horrendousness’: A Qualitative Study Exploring the Barriers and Facilitators to Conducting Trials Involving Adults Lacking Capacity to Consent

Session Details

Tina Neill-Hudson
2022 (San Diego) Annual Meeting

Session Proposal
Using a Single IRB for NIH-Funded Multisite Trials

Session Details

Maiken Pontoppidan
2022 (San Diego) Annual Meeting

Contributed Session
Using Informational Videos to Support Recruitment for Parenting Trials

Session Details

Gail Potter
2022 (San Diego) Annual Meeting

Contributed Session
Using Social Contact Data to Improve the Overall Effect Estimate of a Cluster-Randomized Influenza Vaccination Program in Senegal

Session Details

Heejoon Ahn
2022 (San Diego) Annual Meeting

Contributed Session
Utilization of R Markdown for Automation in Development of Participant Feedback Reports for N-of-1 Trial Designs

Session Details

Anda Dragomir
2022 (San Diego) Annual Meeting

Contributed Session
Validation of a New Digital Tool to Assess Physician Competency in Behaviour Change Counseling: The Motivational Communication Competency Assessment Test

Session Details

Mitchell Paukner
2022 (San Diego) Annual Meeting

Contributed Session
Versatile Window Mean Survival Time: Motivating Trial Design and Analysis with Clinical Relevance

Session Details

Kelly Van Lancker
2022 (San Diego) Annual Meeting

Session Proposal
When and How to Use Covariate Adjustment to Improve Precision in Randomized Trials

Session Details

Kieran O'Brien
2021 (Virtual) Annual Meeting

Contributed Session
The effect of targeting biannual azithromycin distribution by age group on mortality and resistance in Niger: design of an adaptive cluster-randomized large simple trial (AVENIR)

Session Details

Emily Rives
2021 (Virtual) Annual Meeting

Contributed Session
Dynamic Scoring and Guided Data Entry in a Tele-Health Cognitive Battery

Session Details

Gillian Gresham
2021 (Virtual) Annual Meeting

Contributed Session
Evaluating the effect of a mobile audio companion to reduce feelings of distress and loneliness in cancer patients during COVID-19 (COMPANION Trial)

Session Details

Rachel Phillips
2021 (Virtual) Annual Meeting

Contributed Session
Recommendations for visualising the drug harm profile in Randomised Controlled Trials: a consensus

Session Details

Zibo Tian
2021 (Virtual) Annual Meeting

Contributed Session
IMPACT OF UNEQUAL CLUSTER SIZES FOR GENERALIZED ESTIMATING EQUATION ANALYSES OF STEPPED WEDGE DESIGNS WITH BINARY OUTCOMES

Session Details

Lindsay Kehoe
2021 (Virtual) Annual Meeting

Contributed Session
Improving Efficiency by Embedding Trials into Health Care Settings

Session Details

Shelley Vanderhout
2021 (Virtual) Annual Meeting

Contributed Session
PREVALENCE OF AND FACTORS ASSOCIATED WITH PATIENT-REPORTED OUTCOMES IN PRAGMATIC RANDOMIZED CONTROLLED TRIALS

Session Details

Min Zhan
2021 (Virtual) Annual Meeting

Contributed Session
CONSIDERATIONS IN IMPLEMENTING THE ESTIMAND FRAMEWORK IN MULTISITE RANDOMIZED CLINICAL TRIALS

Session Details

Eileen Stock
2021 (Virtual) Annual Meeting

Contributed Session
An Efficient Centralized Statistical Monitoring Program to Improve Data Integrity of Multicenter Clinical Trials

Session Details

Neal Oden
2021 (Virtual) Annual Meeting

Contributed Session
Number of Strata in Clinical Trial Design and Its Impact on Treatment Imbalance

Session Details

Monica Taljaard
2021 (Virtual) Annual Meeting

Contributed Session
HOW ARE CLAIMS OF PRAGMATISM JUSTIFIED IN PRIMARY TRIAL REPORTS? RESULTS FROM A REVIEW OF 415 SELF-DECLARED PRAGMATIC TRIALS

Session Details

Ashley Tjaden
2021 (Virtual) Annual Meeting

Contributed Session
Motivation for participation in a clinical trial among youth and adults with prediabetes or recently diagnosed type 2 diabetes

Session Details

Jennifer Gassman
2021 (Virtual) Annual Meeting

Contributed Session
Use of Vanguard Enrollment to demonstrate feasibility of a high-enrollment surgical trial: The Safe Cholecystectomy OUTcomes (SCOUT) Clinical Trial of Laparoscopic Cholecystectomy (LC)

Session Details

Holly Shaw
2021 (Virtual) Annual Meeting

Contributed Session
Centralized Remote and Risk-Based Monitoring in the INVESTED Trial: a Cost-Effective and Easy-to-Implement Approach

Session Details

Daniele Farrisi
2021 (Virtual) Annual Meeting

Contributed Session
Research Ready: Strategies for Successful Implementation of Research in Clinical Settings

Session Details

Peter McCulloch
2021 (Virtual) Annual Meeting

Contributed Session
Using IDEAL to evaluate research waste in surgery more realistically.

Session Details

Harry Parr
2021 (Virtual) Annual Meeting

Contributed Session
DEVELOPING AND VALIDATING CLINICAL DYNAMIC PREDICTION JOINT MODELS TO PREDICT PROGNOSIS IN PROSTATE CANCER PATIENTS

Session Details

Paola Berchialla
2021 (Virtual) Annual Meeting

Contributed Session
Prediction of treatment outcome and heterogeneous treatment effect in clinical trials: a machine learning approach

Session Details

Leah Pirondini
2021 (Virtual) Annual Meeting

Contributed Session
Covariate adjustment in cardiovascular randomised controlled trials: a review of current practice and simulation studies

Session Details

Lara Maleyeff
2021 (Virtual) Annual Meeting

Contributed Session
Estimating treatment effect heterogeneity in stepped wedge cluster randomized trials with binary outcomes

Session Details

Georgine Price
2021 (Virtual) Annual Meeting

Contributed Session
SITE MONITORING AND SITE MANAGEMENT DURING COVID-19 - A CONTRACT RESEARCH ORGANIZATION’S EXPERIENCE

Session Details

Mitra Lewis
2021 (Virtual) Annual Meeting

Contributed Session
Electronic Data Capture (EDC) system modifications to capture COVID-19 related data in the National Drug Abuse Treatment Clinical Trial Network (NDAT CTN)

Session Details

Monica Taljaard
2021 (Virtual) Annual Meeting

Contributed Session
REPORTING OF INFORMED CONSENT IN PRAGMATIC TRIALS: RESULTS FROM A SYSTEMATIC LITERATURE SURVEY

Session Details

Dario Gregori
2021 (Virtual) Annual Meeting

Contributed Session
The challenge of the COVID-19 pandemic faced by Italian ethics committees: a research survey

Session Details

Giles Partington
2021 (Virtual) Annual Meeting

Contributed Session
The Design and Analysis of Small Population and Rare Disease Trials: A Review of Randomised Trials

Session Details

Daniel Schwartz
2021 (Virtual) Annual Meeting

Contributed Session
Fast and Informative Phase 2b Dose-ranging Trials Using Bayesian Uncertainty-Directed Designs with Model Averaging

Session Details

Emily Roberts
2021 (Virtual) Annual Meeting

Contributed Session
Incorporating Baseline Covariates to Validate Surrogate Endpoints with a Constant Biomarker under Control Arm

Session Details

Matthew Dodd
2021 (Virtual) Annual Meeting

Contributed Session
STATISTICAL METHODS FOR HANDLING NON-ADHERENCE TO INTERVENTIONS IN RANDOMISED NON-INFERIORITY TRIALS: A SYSTEMATIC REVIEW

Session Details

Victoria Cornelius
2021 (Virtual) Annual Meeting

Contributed Session
Improving the analysis of adverse event data in randomised controlled trials

Session Details

Matthew Gooden
2021 (Virtual) Annual Meeting

Contributed Session
Determining the Optimal Percent of Research Records to Review: Reducing the Variability in Audits with Human Research Participants

Session Details

Sharon Love
2021 (Virtual) Annual Meeting

Contributed Session
Making a distinction between data cleaning and central monitoring

Session Details

Lara Philipps
2021 (Virtual) Annual Meeting

Contributed Session
Study within a trial comparing electronic versus paper patient reported outcome collection

Session Details

Diana Papaioannou
2021 (Virtual) Annual Meeting

Contributed Session
Adverse event recording fails to reflect potential harms: A review of trial protocols of behavioural, lifestyle and psychological therapy interventions.

Session Details

Rebecca Silva
2021 (Virtual) Annual Meeting

Contributed Session
Would the recommended dose have been different using novel dose-finding designs? Comparing dose-finding designs in published trials.

Session Details

Xueqi Wang
2021 (Virtual) Annual Meeting

Contributed Session
Power considerations for generalized estimating equations analyses of four-level designs

Session Details

Martin Law
2021 (Virtual) Annual Meeting

Contributed Session
Multi-outcome trials with a generalised number of efficacious outcomes

Session Details

Katie Mellor
2021 (Virtual) Annual Meeting

Contributed Session
PROGRESSION FROM EXTERNAL PILOT TO DEFINITIVE RANDOMISED CONTROLLED TRIAL ARE NOT ADEQUATELY REPORTED: A METHODOLOGICAL REVIEW OF PROGRESSION CRITERIA REPORTING

Session Details

Christina Fu
2021 (Virtual) Annual Meeting

Contributed Session
USE OF COMPREHENSIVE SOLICITED EVENT REPORTING FOR SAFETY MONITORING IN CLINICAL TRIALS WITH STANDARD OF CARE DRUGS

Session Details

Glory Koerbel
2021 (Virtual) Annual Meeting

Contributed Session
HOW CLINICAL TRIAL MANAGEMENT SYSTEMS CAN HELP REDUCE COORDINATOR BURDEN

Session Details

Zhibao Mi
2021 (Virtual) Annual Meeting

Contributed Session
Role of Electronic Health Records in VA CSP Multicenter Clinical Trials

Session Details

Gail Potter
2021 (Virtual) Annual Meeting

Contributed Session
Dismantling the Fragility Index: A Demonstration of Statistical Reasoning

Session Details

Phyllis Goodman
2021 (Virtual) Annual Meeting

Contributed Session
Actions of a National Oncology Group to Manage the Impact of the COVID-19 Pandemic

Session Details

Menelaos Konstantinidis
2021 (Virtual) Annual Meeting

Contributed Session
MULTI-AGENT AGREEMENT COEFFICIENTS: IMPLICATIONS FOR CLINICAL TRIALS OF DIAGNOSTIC TESTING

Session Details

Christin Hoffmann
2021 (Virtual) Annual Meeting

Contributed Session
MEASURING INNOVATION-SPECIFIC OUTCOMES IN STUDIES EVALUATING NEW SURGICAL PROCEDURES AND DEVICES: APPRAISAL AND RECOMMENDATION OF OUTCOME MEASUREMENT INSTRUMENTS USING MODIFIED COSMIN METHODOLOGY

Session Details

Douglas Lammie
2021 (Virtual) Annual Meeting

Contributed Session
Facilitating Study Collaboration in your Pajamas: Replicating a Virtual Office Space While Teleworking"

Session Details

Stuart Nicholls
2021 (Virtual) Annual Meeting

Contributed Session
THE IMPACT OF PATIENT ENGAGEMENT ON TRIALS AND TRIALISTS: AN INTERVIEW STUDY WITH IMPACT AWARDEES

Session Details

Gemma Ainsworth
2021 (Virtual) Annual Meeting

Contributed Session
CO-ENROLMENT OF PATIENTS IN TRIALS OF COMPLEX SURGICAL INTERVENTIONS: RECOMMENDATIONS FROM THE INTACT TRIAL

Session Details

Brian Burke
2021 (Virtual) Annual Meeting

Contributed Session
From Clinical Trial to Observational Study: Long-Term Retention in the TODAY and TODAY2 Studies

Session Details

Saskia Eddy
2021 (Virtual) Annual Meeting

Contributed Session
HOW BIG SHOULD MY PILOT STUDY BE? A METHODOLOGICAL REVIEW

Session Details

Ondrej Blaha
2021 (Virtual) Annual Meeting

Contributed Session
A Bayesian Exact Platform Design for Multi-arm, Phase II trials with Historical Control

Session Details

Kendra Davis-Plourde
2021 (Virtual) Annual Meeting

Contributed Session
Sample size calculation for stepped wedge cluster randomized trials with multiple levels of clustering

Session Details

Brian Burke
2021 (Virtual) Annual Meeting

Contributed Session
Developing an E-Consent System

Session Details

Alyssa Vanderbeek
2021 (Virtual) Annual Meeting

Contributed Session
Consequences of Phase I Dose Selection on Go/No-Go Decisions in Oncology Drug Development

Session Details

Mitchell Paukner
2021 (Virtual) Annual Meeting

Contributed Session
Window Mean Survival Time

Session Details

J Athene Lane
2021 (Virtual) Annual Meeting

Contributed Session
PATIENT AND PUBLIC INVOLVEMENT IN CLINICAL TRIALS: A MIXED METHODS STUDY IN A CLINICAL TRIALS UNIT TO IDENTIFY GOOD PRACTICE, BARRIERS AND FACILITATORS

Session Details

Madeleine Clout
2021 (Virtual) Annual Meeting

Contributed Session
Are Electronic Study Management Systems Acceptable to Participating Sites?

Session Details

Amy Sullivan
2021 (Virtual) Annual Meeting

Contributed Session
What is the (end) point?

Session Details

Joerg Hasford
2021 (Virtual) Annual Meeting

Contributed Session
There are too many p-values smaller 0.01 for clinically relevant primary endpoints reported in randomised trials - results from a systematic analysis of high impact publications

Session Details

Dario Gregori
2021 (Virtual) Annual Meeting

Contributed Session
The state-of-the-art of the Prior Elicitation method in clinical trial design and analysis: a literature review

Session Details

Christopher Schroth
2021 (Virtual) Annual Meeting

Contributed Session
The Record of Study Consultation (RSC): A Tool to Control, Document, & Streamline Sponsor Guidance

Session Details

Sheila Sprague
2021 (Virtual) Annual Meeting

Contributed Session
THE IMPACT OF COVID-19 RESTRICTIONS ON PARTICIPANT ENROLLMENT IN THE PREPARE TRIAL

Session Details

Mudathir Ibrahim
2021 (Virtual) Annual Meeting

Contributed Session
The effects of preceding prospective collaborative studies (IDEAL stage 2b) on the quality and impact of subsequent randomized controlled trials (IDEAL stage 3) evaluating surgical innovations. A case-control systematic review of the literature

Session Details

David Zahrieh
2021 (Virtual) Annual Meeting

Contributed Session
Symbolic two-step method compared with single-step methods to model the center mean outcome in cluster randomized trials

Session Details

Wei Wei
2021 (Virtual) Annual Meeting

Contributed Session
Summarizing historical information for making go/no go decisions in phase II clinical trials

Session Details

Subodh Selukar
2021 (Virtual) Annual Meeting

Contributed Session
STRATIFIED RANDOMIZATION FOR PLATFORM TRIALS WITH DIFFERING EXPERIMENTAL ARM ELIGIBILITY

Session Details

Sasha Kravets
2021 (Virtual) Annual Meeting

Contributed Session
STATISTICAL CONSIDERATIONS FOR SEQUENTIAL, MULTIPLE ASSIGNMENT, RANDOMIZED TRIALS

Session Details

Leslie Revoredo
2021 (Virtual) Annual Meeting

Contributed Session
Responsible Tracking and Accounting of Participant Mental Health Urgency/Emergency Responses in Substance Use Treatment Clinical Trials

Session Details

Yuanxi Jia
2021 (Virtual) Annual Meeting

Contributed Session
Redundant Clinical Trials Are Hurting Patients An Example of Randomized Clinical Trials Conducted in mainland China Evaluating Statins among Patients with Coronary Artery Disease

Session Details

Kimberly Carlson
2021 (Virtual) Annual Meeting

Contributed Session
PTXRx Study: How Pragmatic Trial Design can Inoculate Against Risks to Study Integrity in a Global Pandemic

Session Details

David Zahrieh
2021 (Virtual) Annual Meeting

Contributed Session
Prediction of participant satisfaction in cancer chemoprevention clinical trials using random forests

Session Details

Alyssa Vanderbeek
2021 (Virtual) Annual Meeting

Contributed Session
Platform trials take the spotlight in COVID-19

Session Details

Tao Wang
2021 (Virtual) Annual Meeting

Contributed Session
PHASE I CAR-T CLINICAL TRIALS REVIEW

Session Details

Christin Hoffmann
2021 (Virtual) Annual Meeting

Contributed Session
A CORE OUTCOME SET FOR STANDARDIZING AND REPORTING SURGICAL INNOVATION: RESULTS OF AN INTERNATIONAL DELPHI SURVEY AND CONSENSUS MEETING

Session Details

Radhika Kondapaka
2021 (Virtual) Annual Meeting

Contributed Session
LEVERAGING PATIENT PROFILES FOR ROUTINE PHARMACOVIGILANCE IN CLINICAL TRIALS

Session Details

Sharone Edelstein
2021 (Virtual) Annual Meeting

Contributed Session
Lessons learned from The Restoring Insulin Secretion (RISE) Study: A multi-protocol, multi-center clinical trial in adults and youth with prediabetes and early type 2 diabetes

Session Details

Danila Azzolina
2021 (Virtual) Annual Meeting

Contributed Session
How informative is informative in small size trials: a simulation study

Session Details

Victoria Homer
2021 (Virtual) Annual Meeting

Contributed Session
GUIDELINES FOR THE CONTENT OF STATISTICAL ANALYSIS PLANS FOR EARLY PHASE CLINICAL TRIALS

Session Details

Liyun Jiang
2021 (Virtual) Annual Meeting

Contributed Session
Elastic Priors to Dynamically Borrow Information from Historical Data in Clinical Trials

Session Details

Kathryn Evans
2021 (Virtual) Annual Meeting

Contributed Session
Discriminant validity of the Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS) in adult and pediatric phase II and III clinical trials

Session Details

Kathryn Hefner
2021 (Virtual) Annual Meeting

Contributed Session
Development of a COVID-19 Impact Assessment for National Drug Abuse Treatment (NDAT) Clinical Trials Network (CTN)

Session Details

Marcus Johnson
2021 (Virtual) Annual Meeting

Contributed Session
Development and Implementation of Work Engagement Strategies in a Clinical Research Consortium During the Coronavirus Disease 2019 (COVID-19) Pandemic

Session Details

Siyun Yang
2021 (Virtual) Annual Meeting

Contributed Session
Covariate adjustment in subgroup analyses of randomized clinical trials: A propensity score approach

Session Details

Fei Yuan
2021 (Virtual) Annual Meeting

Contributed Session
Cost-Effectiveness analysis of cardiac versus non-cardiac surgery on cardiovascular-disease population

Session Details

Xiaoyu Tang
2021 (Virtual) Annual Meeting

Contributed Session
Bayesian multivariate network meta-analysis model for the difference in restricted mean survival times

Session Details

Andrea Marraffino
2021 (Virtual) Annual Meeting

Contributed Session
Automated, customized, patient-centric performance feedback in clinical trials to improve data accuracy and patient compliance

Session Details

Shun Fu Lee
2021 (Virtual) Annual Meeting

Contributed Session
Analysis for cluster-randomized crossover trials with multiple periods.

Session Details

Bryan Nelson
2021 (Virtual) Annual Meeting

Contributed Session
An Examination of Methods for Parameter Estimation Following Adaptive Group Sequential Clinical Trials

Session Details

Wen Zhang
2021 (Virtual) Annual Meeting

Contributed Session
A Bayesian group sequential design for randomized biosimilar clinical trials with adaptive information borrowing from historical data

Session Details

Qilu Yu
2021 (Virtual) Annual Meeting

Session Proposal
Managing Pragmatic Clinical Trials in the Time of COVID-19

Session Details

Zachary Hallinan
2021 (Virtual) Annual Meeting

Educational Session
Accelerating evidence generation through quality by design

Session Details

Stefan Englert
2021 (Virtual) Annual Meeting

Educational Session
How the estimand addendum to the ICH E9 guideline helps structure clinical objectives, analyses, and conclusions – a series of oncology case studies

Session Details

Audrey Mauguen
2021 (Virtual) Annual Meeting

Contributed Session
THE TRUE POWER OF CLINICAL TRIALS IN PEDIATRIC CANCERS AND OTHER RARE DISEASES

Session Details

Lauren Balmert
2021 (Virtual) Annual Meeting

Session Proposal
Operational Innovations in Academic Data Analysis and Coordinating Centers

Session Details

Thomas Cook
2021 (Virtual) Annual Meeting

Session Proposal
Missing Data in Clinical Trials: principles, planning, prevention

Session Details

Lehana Thabane
2021 (Virtual) Annual Meeting

Session Proposal
Design and conduct of pilot and feasibility trials: focus on unresolved issues

Session Details

Rema Raman
2021 (Virtual) Annual Meeting

Session Proposal
Impact of the COVID-19 Pandemic on the Design, Operations and Analysis Plans of Dementia Trials

Session Details

The RECOVERY Collaborative Group
2021 (Virtual) Annual Meeting

Trial of the Year Award
RECOVERY - Randomised Evaluation of COVID-19 Therapy

Yves Rosenberg
2021 (Virtual) Annual Meeting

Educational Session
Essentials of Clinical Trials

Session Details

Anna Heath
2021 (Virtual) Annual Meeting

Educational Session
Designing Clinical Research to Inform Decision-Making using Value of Information

Session Details

Susan Halabi, Domenic Reda, Li Chen, Liz Garrett-Mayer, Mithat Gönen, Colin Begg
2021 (Virtual) Annual Meeting

Special Presentation
Annual Business Meeting 2021

J. Jack Lee, 2021 SCT Fellows
2021 (Virtual) Annual Meeting

Fellows Presentation
Presentation of the Class of 2021 Fellows

Pralay Mukhopadhyay
2021 (Virtual) Annual Meeting

Session Proposal
Challenges with COVID-19 Vaccine Development and Assessing Impact of the Pandemic on Oncology Trial Outcomes

Session Details

Darren Courtney
2021 (Virtual) Annual Meeting

Session Proposal
Choices, choices: Selecting, defining, and measuring outcomes for young people with depressive disorders

Session Details

Holly Janes
2021 (Virtual) Annual Meeting

Session Proposal
Current issues in the design and analysis of COVID-19 vaccine efficacy trials

Session Details

Dee Blumberg
2021 (Virtual) Annual Meeting

Session Proposal
Challenges and Best Practices for Recruitment and Retention During the COVID Pandemic

Session Details

James Wason
2021 (Virtual) Annual Meeting

Contributed Session
Costs and Staffing Resource Requirements for Adaptive Trials: results from the Costing Adaptive Trials (CAT) Project

Session Details

Beatriz Goulao
2021 (Virtual) Annual Meeting

Contributed Session
Patient and public involvement in numerical aspects of trials: a theory-informed survey of trialists current practices, barriers and facilitators

Session Details

Yumin Wang
2021 (Virtual) Annual Meeting

Contributed Session
Design and analysis of partially randomized preference trials with propensity score stratification

Session Details

Xinyu Tang
2021 (Virtual) Annual Meeting

Contributed Session
The Use of Conditional Power in Vaccine Trials with Seasonal Variations

Session Details

Laura Levit
2021 (Virtual) Annual Meeting

Session Proposal
It Can Be Done! Equitable, Accessible, and Efficient Clinical Trials Through Streamlined Protocol Designs and Requirements

Session Details

Chen Hu
2021 (Virtual) Annual Meeting

Session Proposal
recent developments in quantitative benefit-risk assessment in clinical trials

Session Details

Tyler Bonnett
2021 (Virtual) Annual Meeting

Session Proposal
Design and Implementation of Clinical Trials in a Pandemic – Reflecting on the ACTT Studies

Session Details

Hayley Belli
2021 (Virtual) Annual Meeting

Contributed Session
Guidelines regarding the enrollment of patients and evidence from Expanded Access programs: A case study of convalescent plasma therapy for the treatment of COVID-19

Session Details

Alice Faust
2021 (Virtual) Annual Meeting

Contributed Session
Challenges and proposed solutions in making clinical research on COVID-19 ethical. A status quo analysis across German research ethics committees

Session Details

Jody Ciolino
2021 (Virtual) Annual Meeting

Contributed Session
Making interim decisions using conditional power based on a surrogate endpoint

Session Details

Arsenio Paez
2021 (Virtual) Annual Meeting

Contributed Session
Intervention fidelity and treatment effect estimates in clinical trials of complex interventions: A meta-epidemiological study.

Session Details

Susan Halabi
2021 (Virtual) Annual Meeting

Session Proposal
SCT New Committees and DMC Training Initiative

Session Details

Monica Taljaard
2021 (Virtual) Annual Meeting

Session Proposal
Pragmatic trials: key unresolved ethical issues and the need for guidance

Session Details

Janel Fedler
2021 (Virtual) Annual Meeting

Session Proposal
The Impact of COVID-19 on the Conduct of Trials in the NeuroNEXT Network

Session Details

Kert Viele
2021 (Virtual) Annual Meeting

Session Proposal
Bayesian Modeling in COVID-19 – Disease Modeling, Therapeutics, and Vaccines

Session Details

Julissa Almonte Santana
2021 (Virtual) Annual Meeting

Contributed Session
Web-Based Lab Tracking for Lab Blood Data Collection and Shipping Manifest Creation

Session Details

Jennifer Le-Rademacher
2021 (Virtual) Annual Meeting

Contributed Session
Adverse Event Burden Score—A Versatile Summary Measure for Cancer Clinical Trials

Session Details

Susan Halabi
2021 (Virtual) Annual Meeting

Contributed Session
On the Design of Stratified Biomaker Trials with Measurement Error

Session Details

Subodh R. Selukar, Siyun Yang, Xiaoyu Tang
2021 (Virtual) Annual Meeting

Award Presentation
Thomas C. Chalmers Scholarship Finalists

Lehana Thabane
2021 (Virtual) Annual Meeting

Session Proposal
INCREASING DIVERSITY IN CARDIOVASCULAR CLINICAL TRIALS: ENGAGEMENT, RECRUITMENT, LEADERSHIP

Session Details

Jonathan Cook
2021 (Virtual) Annual Meeting

Session Proposal
The ASPIRE guidance on surgical placebo controls in randomised trials

Session Details

Erinn Hade
2021 (Virtual) Annual Meeting

Session Proposal
Sample size re-estimation: Reflections on implementation and extensions to complex designs

Session Details

Ashley Wegel
2021 (Virtual) Annual Meeting

Session Proposal
Adaptive COVID-19 Treatment Trial (ACTT) Data Management: Ensuring Success in a Constantly-Evolving, High-Demand Pandemic Environment

Session Details

Sheng Luo
2021 (Virtual) Annual Meeting

Educational Session
Design Clinical Trials with Multiple Endpoints: Methods and Applications

Session Details

Martin Landray
2021 (Virtual) Annual Meeting

Curtis Meinert Lecture
Better Trials for Better Health

Susan Halabi
2021 (Virtual) Annual Meeting

Educational Session
Biomarker Driven Trials for Precision Medicine

Session Details

Jody Ciolino, SCT Membership Committee
2021 (Virtual) Annual Meeting

Special Presentation
New Member Welcome & Orientation

Greg Ball
2021 (Virtual) Annual Meeting

Session Proposal
Different Clinical Trial Analyses for Different Stakeholders

Session Details

Saurabh Mukhopadhyay
2021 (Virtual) Annual Meeting

Session Proposal
Leveraging External Evidence in Clinical Research using Novel Statistical Methods

Session Details

Shahrul Mt-Isa
2021 (Virtual) Annual Meeting

Session Proposal
Benefit-Risk Assessment in Clinical Trials with Individual Patient Needs in Mind

Session Details

James Albert
2021 (Virtual) Annual Meeting

Session Proposal
Design and Implementation of a Vaccine Trial in a Pandemic – mRNA-1273 Phase I Trial

Session Details

Nikki Totton
2021 (Virtual) Annual Meeting

Contributed Session
Utilising Benefit-Risk Assessments within Clinical Trials

Session Details

Sonia Jain
2021 (Virtual) Annual Meeting

Session Proposal
Design, Implementation, and Analysis of N-of-1 Clinical Trials

Session Details

Charles Weijer
2021 (Virtual) Annual Meeting

Session Proposal
Ethics and future of human challenge trials with SARS-CoV-2 to speed vaccine development

Session Details

Cliff Lane
2021 (Virtual) Annual Meeting

Founders Lecture
Conducting Clinical Research in the Setting of an Outbreak: From HIV to Ebola to COVID-19

Dikla Blumberg
2020 (Virtual) Annual Meeting

Session Proposal
Strategies to Collaboratively Manage Protocol Deviations in Multi-Site Clinical Trials

Session Details

Amy Ruppert Stark
2020 (Virtual) Annual Meeting

Session Proposal
The design and implementation of Master Protocols using examples from oncology clinical trials.

Session Details

Simon Bacon
2020 (Virtual) Annual Meeting

Session Proposal
Methodological advances in the conduct of behavioral clinical trials: An International Behavioural Trials Network (IBTN) update.

Session Details

Lu Mao Mao
2020 (Virtual) Annual Meeting

Session Proposal
The win ratio approach to composite endpoints

Session Details

Brooke Erchinger
2020 (Virtual) Annual Meeting

Educational Session
Using meta-analysis to combine results from clinical trials

Session Details

Susan Czajkowski
2020 (Virtual) Annual Meeting

Educational Session
From Ideas to Efficacy: Designing & Optimizing Behavioral Treatments for Chronic Diseases

Session Details

Cody Chiuzan
2020 (Virtual) Annual Meeting

Educational Session
Web-based applications for early-phase trials designs

Session Details

Michael Rosenblum
2020 (Virtual) Annual Meeting

Session Proposal
Adjusting for Prognostic Baseline Variables to Improve Precision and Power in Randomized Trials

Session Details

Elizabeth Wright
2020 (Virtual) Annual Meeting

Session Proposal
Management and Sharing of Individual Participant Deidentified Data (IPD)

Session Details

Andrew Embleton-Thirsk
2020 (Virtual) Annual Meeting

Contributed Session
Contrasting case-studies of non-commercial trials being used as a pivotal evidence in licencing submissions to the European Medicines Agency

Session Details

Meredith Warshaw
2020 (Virtual) Annual Meeting

Contributed Session
IMPAACT 2016: Interdisciplinary Collaboration at Multiple Levels

Session Details

Jason Kojtek
2020 (Virtual) Annual Meeting

Contributed Session
Building a drug management system

Session Details

Susan Halabi, Mithat Gönen
2020 (Virtual) Annual Meeting

Fellows Presentation
Presentation of the Class of 2020 Fellows

Levent Bayman
2020 (Virtual) Annual Meeting

Contributed Session
Real-Time Risk-Based Monitoring in Clinical Trials Using Business Intelligence Tools (Unlikely Companions)

Session Details

Levent Bayman
2020 (Virtual) Annual Meeting

Contributed Session
Transition From Two Phase 3 Clinical Trials To A Reduced Follow-Up Only Trial

Session Details

Deborah Zarin
2020 (Virtual) Annual Meeting

Contributed Session
Addressing Challenges in Registering and Reporting Results for Master Protocol Studies

Session Details

Anna Heath
2020 (Virtual) Annual Meeting

Contributed Session
A Bayesian Continual Reassessment Design for a Dose Ranging Study of Intranasal Dexmedetomidine for Paediatric Laceration Repair

Session Details

Anna Heath
2020 (Virtual) Annual Meeting

Contributed Session
The KidsCAN-PERC Innovative Paediatric Clinical Trials Network (iPCT): An Interdisciplinary Approach to Clinical Trials Methodology.

Session Details

Anna Heath
2020 (Virtual) Annual Meeting

Contributed Session
Determining a Bayesian Predictive Power Stopping Rule for Futility in a Non-Inferiority Trial with Binary Outcomes: The INK trial

Session Details

Chris Rogers
2020 (Virtual) Annual Meeting

Contributed Session
Automation of clinical trial statistical monitoring

Session Details

Danila Azzolina
2020 (Virtual) Annual Meeting

Contributed Session
Bayesian HPD-based sample sizedetermination using semi-parametric prior elicitation

Session Details

Daniele Bottigliengo
2020 (Virtual) Annual Meeting

Contributed Session
Central Statistical Data Quality Monitoring in Clinical Studies: an application to the ROLEX registry

Session Details

Danila Azzolina
2020 (Virtual) Annual Meeting

Contributed Session
Bayesian methods to cope with poor accrual in pediatric trials

Session Details

Kelly Folkers
2020 (Virtual) Annual Meeting

Contributed Session
Data from Expanded Access: Opportunity for Real World Evidence Collection and Insights?

Session Details

Fuad Abujarad
2020 (Virtual) Annual Meeting

Contributed Session
Comparing a Multimedia Interactive Virtual Informed Consent (VIC) to Traditional Paper-based Method: A randomized Clinical Trial

Session Details

Ilaria Domenicano
2020 (Virtual) Annual Meeting

Contributed Session
Determining mental health condition patterns in Veterans with a lifetime PTSD diagnosis

Session Details

Grecio Sandoval
2020 (Virtual) Annual Meeting

Contributed Session
Cost-Efficient Clinical Studies with Continuous Time-to-Event Outcomes

Session Details

Jessica Guyer
2020 (Virtual) Annual Meeting

Contributed Session
Clinical Trial Design, Protocol Implementation, and Secular Treatment Trends for Persons Living with HIV and Opioid Use Disorder: Lessons Learned from a National Institute on Drug Abuse Clinical Trials Network (CTN) Trial

Session Details

Fei Yuan
2020 (Virtual) Annual Meeting

Contributed Session
The Association between Genotypes and Post Cardiac Surgery Bleedings: A substudy of the Steroids in Cardiac Surgery Trial (SIRS)

Session Details

Lucy Culliford
2020 (Virtual) Annual Meeting

Contributed Session
Do study participants complete electronic questionnaires?

Session Details

Shray Alag
2020 (Virtual) Annual Meeting

Contributed Session
Extracting Unique Insights by Mining Single Nucleotide Polymorphisms (SNPs) from ClinicalTrials.gov and Applying the Human Phenotype Ontology

Session Details

Rick Mitchell
2020 (Virtual) Annual Meeting

Contributed Session
Ensuring Consistency Across CDISC Dataset Programming Processes

Session Details

Daniel Kang
2020 (Virtual) Annual Meeting

Contributed Session
Efficient Bayesian Adaptive Design for Oncology Clinical Trials with Multiple Biomarker Subgroups

Session Details

Nora Hutchinson
2020 (Virtual) Annual Meeting

Contributed Session
How Many Patients Does It Take to Develop a New Cancer Drug? A Cohort Study of Pre-license Oncology Drugs

Session Details

Jonathan Walsh
2020 (Virtual) Annual Meeting

Contributed Session
Improving Clinical Trial Efficiency Using Machine Learning Models of Disease Progression

Session Details

Russell Thirard
2020 (Virtual) Annual Meeting

Contributed Session
Integrating expert opinions with clinical trial data to increase power to detect a treatment effect in subgroups: example of a Bayesian analysis of the VeRDiCT trial

Session Details

Chris Rogers
2020 (Virtual) Annual Meeting

Contributed Session
Instrumental variable methods for assessing the causal effect of an intervention in the presence of differential non-adherence; application to the AIRWAYS-2 trial

Session Details

Yuanyuan Lu
2020 (Virtual) Annual Meeting

Contributed Session
How Big is a Big Hazard Ratio in Clinical Trials?

Session Details

Dikla Blumberg
2020 (Virtual) Annual Meeting

Session Proposal
Regulatory considerations for a multi-site clinical trial treating opioid use disorder (OUD) with vulnerable populations: pregnant women, infants, and potential prisoners

Session Details

Yue Song
2020 (Virtual) Annual Meeting

Contributed Session
Random-effects meta-analysis of combined outcomes based on reconstructions of individual patient data

Session Details

Kristina Lindsley
2020 (Virtual) Annual Meeting

Contributed Session
Public availability of clinical trial results from a random sample of systematic reviews

Session Details

Matthew Gooden
2020 (Virtual) Annual Meeting

Contributed Session
The Impact of Site Initiation Visits on Non Compliance in Neurology Research

Session Details

Alicia Williams
2020 (Virtual) Annual Meeting

Contributed Session
The Impact of Different Missing Data Imputation Methods: a case study using the Veterans Affairs Nephropathy in Diabetes (VA NEPHRON-D) Study

Session Details

Alisa Stephens-Shields
2020 (Virtual) Annual Meeting

Contributed Session
Simulation-based Design of Pragmatic Trials in Psoriatic Arthritis Using Propensity Scores

Session Details

Rouba Chahine
2020 (Virtual) Annual Meeting

Contributed Session
Sample Size Methods for Two-Stage Randomized Trials with Time to Event Data

Session Details

Isabelle Weir
2020 (Virtual) Annual Meeting

Contributed Session
Counterfactual mediation analysis with multistate models for surrogate and clinical time-to-event outcomes

Session Details

Victoria Trapani
2020 (Virtual) Annual Meeting

Contributed Session
Vital Status Ascertainment in a Long-Term Clinical Study of Type 1 Diabetes

Session Details

Wendi Liang
2020 (Virtual) Annual Meeting

Contributed Session
Using Results from a Natural History Study to Reduce Patient Burden in Later Clinical Trials

Session Details

Phoebe Gauthier
2020 (Virtual) Annual Meeting

Contributed Session
Using an Interdisciplinary Approach to Develop a Medical Record Abstraction and Quality Assurance Process for Generating the Primary Outcome in a Multi-Site Implementation Study

Session Details

Deborah Profit, PhD
2020 (Virtual) Annual Meeting

Contributed Session
The Value Proposition of eConsent in Clinical Trials

Session Details

Catherine Houghton
2020 (Virtual) Annual Meeting

Contributed Session
Potential participants’ views on the factors that impact on their decision to take part in a randomised trial: A qualitative evidence synthesis.

Session Details

Patricia Vanderwolf
2020 (Virtual) Annual Meeting

Contributed Session
Patient-Focused Research on Metachromatic Leukodystrophy

Session Details

Richard Hooper
2020 (Virtual) Annual Meeting

Contributed Session
Optimal incomplete designs for stepped wedge trials in continuous time

Session Details

Anna Heath
2020 (Virtual) Annual Meeting

Contributed Session
Adaptive Seamless Phase II/III Design for the Ketodex trial

Session Details

Jiyu Kim
2020 (Virtual) Annual Meeting

Contributed Session
Analysis of multicenter clinical trials with very low event rates

Session Details

ASM Borhan
2020 (Virtual) Annual Meeting

Contributed Session
Analysis and reporting of data from stratified cluster randomized trials – a systematic survey

Session Details

Emily Hite
2020 (Virtual) Annual Meeting

Contributed Session
An examination of treatment interventions for glioblastoma multiforme and its affect on patient withdrawals/drop outs

Session Details

Guilherme Lopes
2020 (Virtual) Annual Meeting

Contributed Session
A novel method of reporting adverse effects in cancer clinical trials.

Session Details

Student finalists presenting their papers and the winner announced live during the webinar!
2020 (Virtual) Annual Meeting

Award Presentation
Thomas C. Chalmers Student Scholarship

Jean-Jacques Muyembe-Tamfum, Lori Dodd, Oliver Tshiani Mbala, and Jamila Adoulhab
2020 (Virtual) Annual Meeting

Trial of the Year Award
Pamoja Tulinde Maisha (PALM ["Together Save Lives"] in the Kiswahili language) trial

SCT President, Officers and Committee Chairs
2020 (Virtual) Annual Meeting

Special Presentation
Annual Business Meeting 2020

Chengwu Yang
2020 (Virtual) Annual Meeting

Award Presentation
Sylvan Green Award

Michael Grayling
2020 (Virtual) Annual Meeting

Contributed Session
Where is the good? The bad and the ugly of single-arm trial reporting

Session Details

Penny Reynolds
2020 (Virtual) Annual Meeting

Contributed Session
Where have all the trials gone? Academic trialists do not report clinical trial results

Session Details

James Moore
2020 (Virtual) Annual Meeting

Contributed Session
Wearable Devices: Technology, Time Issues and Statistical Resolutions

Session Details

Quyen Duong
2020 (Virtual) Annual Meeting

Contributed Session
Understanding Verbosity: Associations between Consent Form Length and Funding Source in Cancer Clinical Trials

Session Details

Kari Williams
2020 (Virtual) Annual Meeting

Contributed Session
The Impact of Interdisciplinary Relationships on Single IRB Selection in a National Clinical Trial Network

Session Details

Arsenio Paez
2020 (Virtual) Annual Meeting

Contributed Session
The IDEAL Reporting Guidelines for Reporting the Evaluation of Surgical Innovation

Session Details

Arsenio Paez
2020 (Virtual) Annual Meeting

Contributed Session
The CONSIDER framework - Guiding intervention fidelity and study design in clinical trials of surgery.

Session Details

Kathryn Arnold
2020 (Virtual) Annual Meeting

Contributed Session
Successful implementation of a novel trial design in a palliative care population

Session Details

Xiaoyan Yin
2020 (Virtual) Annual Meeting

Contributed Session
Sequential, Multiple-Assignment, Randomized Trials for COMparing Personalized Antibiotic StrategieS (SMART-COMPASS): Design Considerations for Selecting the Optimal Treatment

Session Details

Janel Fedler
2020 (Virtual) Annual Meeting

Contributed Session
Sample Size Estimates for Optical Coherence Tomography Outcome Measures Based on Trends Observed in the SPRINT-MS Trial

Session Details

Kevin Fain
2020 (Virtual) Annual Meeting

Contributed Session
Race and ethnicity reporting for clinical trials in ClinicalTrials.gov and publications.

Session Details

Muniza Sheikh
2020 (Virtual) Annual Meeting

Contributed Session
National Institute of Neurological Disorders and Stroke (NINDS) Common Data Element (CDE) Recommendations: Project Overview and Recent Updates

Session Details

Michael Grayling
2020 (Virtual) Annual Meeting

Contributed Session
Multi-arm multi-stage designs with fixed stage-wise sample sizes

Session Details

Lawrence Ragard
2020 (Virtual) Annual Meeting

Contributed Session
Interdisciplinary collaboration in review of national coverage analysis (NCA) documents to enhance clinical trial site activation and recruitment of participants.

Session Details

Elias Klemperer
2020 (Virtual) Annual Meeting

Contributed Session
Implementation, recruitment, and retention for an emergency department initiated buprenorphine intervention for opioid use disorder

Session Details

Elizabeth Wright
2020 (Virtual) Annual Meeting

Contributed Session
Data Sharing Plans in Manuscripts Reporting Results of Randomized Clinical Trials Published in International Committee of Medical Journal Editors Member Journals during 2019

Session Details

Joseph Rausch
2020 (Virtual) Annual Meeting

Contributed Session
Comparing ANCOVA and Constrained Longitudinal Data Analysis for Examining Moderators in Randomized Clinical Trials

Session Details

Brian Burke
2020 (Virtual) Annual Meeting

Contributed Session
Closing Out a Long-Term Longitudinal Study: Lessons from the TODAY Study

Session Details

Chenxiang Li
2020 (Virtual) Annual Meeting

Contributed Session
Generalization of Randomized Trial Results with Latent Motivation – A Propensity Score Approach

Session Details

Lan Zhang
2020 (Virtual) Annual Meeting

Contributed Session
Buy or Build: Considerations for a robust data management system used in Phase 3 Clinical Studies

Session Details

James Wise
2020 (Virtual) Annual Meeting

Contributed Session
Building a Comprehensive Clinical Site Performance Portal in Support of Risk-Based Monitoring

Session Details

Christina Clise
2020 (Virtual) Annual Meeting

Contributed Session
Blurring the Boundaries Between Clinical Trials and Healthcare Ecosystems.

Session Details

Joel Gagnier
2020 (Virtual) Annual Meeting

Contributed Session
Bias Associated with Patient Reported Outcome Measures in Meta-Analyses

Session Details

Arsenio Paez
2020 (Virtual) Annual Meeting

Contributed Session
Beyond the RCT: When are randomised trials unnecessary for new therapeutic devices, and what should we do instead?

Session Details

Carlton Hornung
2020 (Virtual) Annual Meeting

Contributed Session
Assessing the Competency of the Clinical Research Workforce: Formal Education; Role in the Research Enterprise; Research Setting; and Years of Experience.

Session Details

Tolulope Abidogun
2020 (Virtual) Annual Meeting

Contributed Session
Analysis of Intent to Share Individual Participant Data (IPD) for Clinical Trials Registered on ClinicalTrials.gov

Session Details

Arsenio Paez
2020 (Virtual) Annual Meeting

Contributed Session
An introduction to ideal

Session Details

Caroline Kristunas
2020 (Virtual) Annual Meeting

Contributed Session
An evaluation of the use of covariate constrained randomisation for stepped-wedge cluster randomised trial

Session Details

Gary Gensler
2020 (Virtual) Annual Meeting

Contributed Session
Addressing changes to a closeout data set

Session Details

Janet Athene Lane
2020 (Virtual) Annual Meeting

Contributed Session
A digital story of strategies for surgical trainees working together to achieve success in conducting surgical clinical trials

Session Details

Graham Wheeler
2020 (Virtual) Annual Meeting

Educational Session
How to design and run an adaptive clinical trial: new resources and easy-to-use software

Session Details

James Wagner
2020 (Virtual) Annual Meeting

Educational Session
Improving Quality and Controlling Costs in Clinical Trials Using Responsive Survey Design

Session Details

Various Speakers
2019 (New Orleans) Annual Meeting

Special Presentation
Special Founders Session

James J. Dignam & Letitia Perdue
2019 (New Orleans) Annual Meeting

Award Presentation
Thomas C. Chalmers Scholarship, Sylvan Green & Poster Awards

Dr. Monica Bertagnolli
2019 (New Orleans) Annual Meeting

Founders Lecture
Building a learning health care system, and learning from every patient

Susan Halabi
2019 (New Orleans) Annual Meeting

Fellows Presentation
Presentation of the Class of 2019 Fellows

Dr. Lynette Keyes-Elstein
2019 (New Orleans) Annual Meeting

Trial of the Year Award
The Scleroderma: Cyclophosphamide or Transplantation (SCOT) trial

Sumithra Mandrekar
2019 (New Orleans) Annual Meeting

Presidential Welcome
Clinical Trials: A Catalyst for Societal Advancement through Innovation

Thomas Fleming
2019 (New Orleans) Annual Meeting

Curtis Meinert Lecture
Striving to achieve and protect the integrity of clinical trials

Li Chen
2019 (New Orleans) Annual Meeting

Session Proposal
Synthesize Read-World Data with Randomized Clinical Trial Data for Efficient Drug Development

Session Details

Joel Stevans
2019 (New Orleans) Annual Meeting

Contributed Session
Implementation of the Multi-Site Pragmatic Cluster Randomized Controlled Trial: Targeted Interventions to Prevent Chronic Low Back Pain (LBP) in High Risk Patients (TARGET)

Session Details

Charity Patterson
2019 (New Orleans) Annual Meeting

Contributed Session
MULTIPLE, INNOVATIVE, REDCAP PROJECTS FOR TWO SIMULTANEOUS MULTICENTER TRIALS.

Session Details

Rebecca Neiberg
2019 (New Orleans) Annual Meeting

Contributed Session
ASSESSING DATA QUALITY OF PARTICIPANT WEIGHTS UPLOADED FROM SMART SCALES: THE STUDY OF NOVEL APPROACHES TO PREVENTION CLINICAL TRIAL – EXTENSION PHASE

Session Details

Kelley Kidwell
2019 (New Orleans) Annual Meeting

Educational Session
SMART clinical trial design for large and small samples

Session Details

Shaun Treweek
2019 (New Orleans) Annual Meeting

Contributed Session
Increasing the trial process evidence base without increasing research waste

Session Details

David Kent
2019 (New Orleans) Annual Meeting

Educational Session
Personalized evidence based medicine: predictive approaches to heterogeneous treatment effects in randomized trials

Session Details

Juliana Tolles
2019 (New Orleans) Annual Meeting

Session Proposal
Challenges and Best Practices for Data Monitoring Committees (DMCs) Overseeing Adaptive Clinical Trials

Session Details

Jessica Kasza
2019 (New Orleans) Annual Meeting

Contributed Session
Staircase cluster randomised trial designs

Session Details

Katie Jentoft
2019 (New Orleans) Annual Meeting

Contributed Session
CONVERTING VALIDATED SCALES INTO CONSOLIDATED ELECTRONIC CASE REPORT FORMS

Session Details

Shun Fu Lee
2019 (New Orleans) Annual Meeting

Contributed Session
Sample size calculation for cluster randomized crossover trials of multiple periods.

Session Details

Kerry Avery
2019 (New Orleans) Annual Meeting

Contributed Session
A modular core outcome set for seamless, standardised evaluation and reporting of outcomes throughout the surgical device innovation lifecycle: the COHESIVE study

Session Details

Kerry Avery
2019 (New Orleans) Annual Meeting

Contributed Session
Developing a hospital-integrated system for electronic patient-reporting, detection and management of symptoms and complications after surgery

Session Details

Various Speakers
2019 (New Orleans) Annual Meeting

Special Presentation
Annual Business Meeting 2019

Gareth Davies
2019 (New Orleans) Annual Meeting

Contributed Session
Surgeons’ lack of understanding of levels of evidence and trial methodology is a major barrier to randomized trials in surgery

Session Details

Naveen Pereira
2019 (New Orleans) Annual Meeting

Contributed Session
TAILOR PCI: Transitioning a Genotype Based Randomized Clinical Trial to a Registry Using Digital Solutions

Session Details

Lisa Bailey
2019 (New Orleans) Annual Meeting

Contributed Session
'Don't Cut it Out': The Importance of Quality Control in Surgical Trials

Session Details

Kate Harvey
2019 (New Orleans) Annual Meeting

Contributed Session
‘Exploring the feasibility of using mixed methods within an IDEAL 2a/2b study to facilitate the safe, transparent and efficient early-phase evaluation of a novel surgical technique: The Pre-BRA study.’

Session Details

Kerenza Hood
2019 (New Orleans) Annual Meeting

Contributed Session
‘First do no harm’ – exploring the potential impact of placebo treatments on adverse effects

Session Details

Shaunagh Browning
2019 (New Orleans) Annual Meeting

Session Proposal
“The Clinical Research Nurse in Clinical Trials: Value Added?” A Panel Discussion on the Nurses' Role on the Clinical Trials Team

Session Details

Thomas Tollefsen
2019 (New Orleans) Annual Meeting

Contributed Session
“What matters to you?” Preliminary results from a randomized controlled effectiveness trial

Session Details

Kandi Velarde
2019 (New Orleans) Annual Meeting

Contributed Session
A Bold Collaboration Between the Recruitment Innovation Center (RIC) and the Department of Veterans Affairs (VA) to Develop a Case-Based Framework for Sharing Algorithmic Approaches to Facilitate Clinical Research Planning and Recruitment

Session Details

Ayoola Ademola
2019 (New Orleans) Annual Meeting

Contributed Session
A Comparison of Frequentist and Bayesian Power Analyses for Non-Inferiority Trials Designs

Session Details

Gillian Gresham
2019 (New Orleans) Annual Meeting

Contributed Session
A Comparison of Industry and NIH-funded Clinical Trials Registered in ClinicalTrials.gov

Session Details

Tolu Sajobi
2019 (New Orleans) Annual Meeting

Contributed Session
A Differential Item Functioning Analysis of the DASH Outcome Measure in a Randomized Controlled Trial of Patients with Elbow Fractures

Session Details

Andrew Chapple
2019 (New Orleans) Annual Meeting

Contributed Session
A Hybrid Phase I-II/III Clinical Trial Design Allowing Dose Re-Optimization in Phase III

Session Details

Tolulope Sajobi
2019 (New Orleans) Annual Meeting

Contributed Session
A Literature Review of Baseline Covariate Adjustment Methods in Randomized Clinical Trials

Session Details

Martin Law
2019 (New Orleans) Annual Meeting

Contributed Session
A new class of optimally curtailed trials for phase II oncology trials.

Session Details

Brittney Bailey
2019 (New Orleans) Annual Meeting

Contributed Session
A new predictive mean matching imputation method for data from cluster randomized trials

Session Details

RANI JAYSWAL
2019 (New Orleans) Annual Meeting

Contributed Session
A novel method for PFS ratio endpoint in a Phase II genomic-driven clinical trial

Session Details

Karen Beck
2019 (New Orleans) Annual Meeting

Contributed Session
A Pilot Study to Assess Feasibility and Acceptability of At-Home Self-Collection Sampling for Urine and Saliva

Session Details

Chaoqun Mei
2019 (New Orleans) Annual Meeting

Contributed Session
A Procedure for Comparison of Matched Pairs by Ranking Method

Session Details

Hongli Li
2019 (New Orleans) Annual Meeting

Contributed Session
A Programmatic Approach to the Increased Data Monitoring in the Cooperative Group System Required for FDA Registration Trials

Session Details

Lisa Henn
2019 (New Orleans) Annual Meeting

Contributed Session
A Randomized Controlled Trial with right-skewed dual endpoints in the presence of an unproven but incumbent competing intervention: Rationale and design

Session Details

Michael Grayling
2019 (New Orleans) Annual Meeting

Contributed Session
A review of software availability for adaptive clinical trials

Session Details

J Athene Lane
2019 (New Orleans) Annual Meeting

Contributed Session
A systematic literature review of site staff training methods in clinical trials

Session Details

Thevaa Chandereng
2019 (New Orleans) Annual Meeting

Contributed Session
A Tool for Design and Analysis of Adaptive Bayesian Clinical Trials

Session Details

Chin-Fu Hsiao
2019 (New Orleans) Annual Meeting

Contributed Session
A two-stage selection designs for basket clinical trials

Session Details

Zhenning Yu
2019 (New Orleans) Annual Meeting

Contributed Session
A Unified Approach for Frequentist and Bayesian Hypothesis Testing in Two-Arm Clinical Trials with Binary Outcomes

Session Details

Toshimitsu Hamasaki
2019 (New Orleans) Annual Meeting

Contributed Session
A use of adaptive design in clinical trial for evaluating safety and efficacy of the extracorporeal continuous-flow ventricular assist device in patients with severe heart failure or refractory cardiogenic shock

Session Details

Julia Robertson
2019 (New Orleans) Annual Meeting

Contributed Session
A Web-Based Approach for Tracking and Management of Sleep Device Mailings for In-Home Sleep Assessments in the WHISPER Study

Session Details

Katherine Snapinn
2019 (New Orleans) Annual Meeting

Contributed Session
Achieving balance between standardization and customization with the Statisticians’ Report Worksheet

Session Details

Donna Levy
2019 (New Orleans) Annual Meeting

Contributed Session
Adaptive Designs - Introduction for Non-statisticians - What are they? How do they impact me? What do I need to know?

Session Details

Yannan Jiang
2019 (New Orleans) Annual Meeting

Contributed Session
All New Zealand Acute Coronary Syndrome - Quality Improvement (ANZACS-QI) Programme: Using Routinely Collected National Patient Database for Clinical Trials

Session Details

Kevin Fain
2019 (New Orleans) Annual Meeting

Contributed Session
All-cause mortality reporting in ClinicalTrials.gov compared to publications.

Session Details

Fang-Shu Ou
2019 (New Orleans) Annual Meeting

Contributed Session
Alternative test statistics and their power under non-proportional hazard assumptions

Session Details

Hayley Belli
2019 (New Orleans) Annual Meeting

Contributed Session
An algorithmic approach for determining individualized stage duration in a Sequential Multiple Assignment Randomized Trial (SMART)

Session Details

Jacqueline Chen
2019 (New Orleans) Annual Meeting

Contributed Session
Analysis of Drug Labeling for Information Specific to Geriatric Populations

Session Details

Cindy Cooper
2019 (New Orleans) Annual Meeting

Contributed Session
Anticipated and observed effect sizes in publicly funded randomised controlled trials

Session Details

Jeffery Oliver
2019 (New Orleans) Annual Meeting

Contributed Session
APPLICATION OF KEY RISK INDICATORS TO IMPROVE DATA QUALITY: A NUTRITION COMPANY’S PERSPECTIVE

Session Details

Rene Peralta
2019 (New Orleans) Annual Meeting

Contributed Session
Application of the NIST Randomness Beacon to randomized trials.

Session Details

Jeannette Lee
2019 (New Orleans) Annual Meeting

Contributed Session
Assessing Clinical Trial Self-Perceived Competence Among International Sites Participating in the AIDS Malignancy Consortium

Session Details

Virginia Shipes
2019 (New Orleans) Annual Meeting

Contributed Session
Assessing the Robustness of Interim Stopping Criteria Methods in Phase III Survival Clinical Trials

Session Details

Lindsey Cameron-Dermann
2019 (New Orleans) Annual Meeting

Contributed Session
Association between estrogen and prevalent health-related quality of life in postmenopausal women randomized to the MAP.3 chemoprevention trial

Session Details

Shirley Ge
2019 (New Orleans) Annual Meeting

Contributed Session
Automated Assignment of Congenital Heart Surgery Procedure Types for Accurate Prediction of ICU Length-of-Stay

Session Details

Wenle Zhao
2019 (New Orleans) Annual Meeting

Contributed Session
Automated Site-Subject Payment Management System for Multi-center Clinical Trials

Session Details

Amanda MacPherson
2019 (New Orleans) Annual Meeting

Contributed Session
Benefit and burden in trials of novel, disease-modifying interventions in neurodegenerative disease: A systematic review and meta-analysis

Session Details

Derk Arts
2019 (New Orleans) Annual Meeting

Contributed Session
Benefits of dynamic consent in research - now and tomorrow

Session Details

Lehana THABANE
2019 (New Orleans) Annual Meeting

Educational Session
Beyond the CONSORT extension for pilot trials: guideline, planning, abstracts and protocols

Session Details

Joel Gagnier
2019 (New Orleans) Annual Meeting

Contributed Session
Bias Associated With Patient Reported Outcome Measures in Clinical Trials

Session Details

Lifeng Lin
2019 (New Orleans) Annual Meeting

Contributed Session
Borrowing of strength from indirect evidence in network meta-analyses

Session Details

Zarah Monfaredi
2019 (New Orleans) Annual Meeting

Contributed Session
Building the infrastructure to support patient engagement in clinical trials within an academic hospital

Session Details

Yumi Wakabayashi
2019 (New Orleans) Annual Meeting

Contributed Session
Categorization of Medical Information Databases

Session Details

Pralay Mukhopadhyay
2019 (New Orleans) Annual Meeting

Session Proposal
Challenges in Design, Analysis and Selection of Endpoints in Immuno-Oncology Trials

Session Details

Susanna Barber
2019 (New Orleans) Annual Meeting

Contributed Session
Challenges to Preventing Pregnancy During Ebola Vaccine Clinical Trials in Liberia

Session Details

Matthew Parkes
2019 (New Orleans) Annual Meeting

Contributed Session
Change in Pain and Physical Activity in the InRespond Trial: Can Composite Outcomes Improve Responsiveness?

Session Details

Jianrong Zhang
2019 (New Orleans) Annual Meeting

Contributed Session
Clinical Benefits on Progression-free Survival between Blinded Independent Central Review and Local Assessment in Phase III Randomized Controlled Trials on Solid Tumors: An Analysis of the Results from a Systematic Review

Session Details

SUSAN Ellenberg
2019 (New Orleans) Annual Meeting

Educational Session
Clinical Trial Data Monitoring Committees and Reporting Statistical Centers: The Basics and Emerging Issues

Session Details

Cole Wayant
2019 (New Orleans) Annual Meeting

Contributed Session
Clinical trial endpoints in oncology drug advertisements: a potential mechanism for hype?

Session Details

Mary Redman
2019 (New Orleans) Annual Meeting

Session Proposal
Clinical Trialists Can Help Make Real-World Data Analysis Better

Session Details

Andrew Pilecki
2019 (New Orleans) Annual Meeting

Contributed Session
Clinical trials and healthcare professionals: An analysis of primary factors driving referral behaviors

Session Details

Colin Begg
2019 (New Orleans) Annual Meeting

Session Proposal
Clinical Trials: Meet the Editors

Session Details

Denise Esserman
2019 (New Orleans) Annual Meeting

Session Proposal
Clinical, Practical and Methodological Considerations for Patient Preference Clinical Trials Designs

Session Details

Larisa Tereshchenko
2019 (New Orleans) Annual Meeting

Session Proposal
Clinician-reported outcomes: can we do better?

Session Details

Sarah Gaussoin
2019 (New Orleans) Annual Meeting

Contributed Session
COcoa Supplement and Multivitamin Outcomes Study of Cognitive Function (COSMOS-Mind): Design of a Large Randomized Clinical Trial

Session Details

Matthew` Schipper
2019 (New Orleans) Annual Meeting

Contributed Session
Comparing treatments effect estimates in oncology using randomized clinical trials and observational registries

Session Details

Adelaide Doussau
2019 (New Orleans) Annual Meeting

Contributed Session
Comparison Between Protocols and Publications for Prognostic and Predictive Cancer Biomarker Studies

Session Details

Rebecca Lewis
2019 (New Orleans) Annual Meeting

Contributed Session
Considerations in implementing an electronic patient reported outcomes (ePRO) system

Session Details

Julia Collins
2019 (New Orleans) Annual Meeting

Contributed Session
Considerations in Selection of a Single IRB of Record for Multi-Site Trials

Session Details

Meaghan Adkisson
2019 (New Orleans) Annual Meeting

Contributed Session
Consistent Data Collection Across Multiple Countries

Session Details

Peter Kaufmann
2019 (New Orleans) Annual Meeting

Educational Session
Control Groups, Clinically Important Differences and Effect Sizes in Complex Interventions

Session Details

Jennifer Talton
2019 (New Orleans) Annual Meeting

Contributed Session
Creating Dynamic SAS Reports Across Multiple REDCap Projects

Session Details

Gillian Lancaster
2019 (New Orleans) Annual Meeting

Contributed Session
Creation of the WHO indicators of Infant and Young Child Development (IYCD) as an outcome measure for assessing pre-primary interventions in low and middle income countries: meta data synthesis and field testing methodology

Session Details

Diane Hartford
2019 (New Orleans) Annual Meeting

Contributed Session
Crowdsourcing Solutions for RCT Study Start-Up Pain Points

Session Details

Jack White
2019 (New Orleans) Annual Meeting

Contributed Session
Data Integration in a Multi-site Intervention Through Use of Application Programming Interfaces (APIs)

Session Details

Andrew Rygiel
2019 (New Orleans) Annual Meeting

Contributed Session
DEFINING EVALUABILITY IN A PHASE II, PROSPECTIVE, NON-RANDOMIZED, PRAGMATIC CANCER CLINICAL TRIAL

Session Details

Andrea Anderson
2019 (New Orleans) Annual Meeting

Contributed Session
Designing an Adherence Tracking System for an International Trial

Session Details

Nolan Wages
2019 (New Orleans) Annual Meeting

Educational Session
Designs for modern phase I oncology trials

Session Details

Julie Croft
2019 (New Orleans) Annual Meeting

Contributed Session
Development of a resource to guide set-up and conduct of international surgical clinical trials

Session Details

Manqi Cai
2019 (New Orleans) Annual Meeting

Contributed Session
Development of Methods to handle medication non-adherence in Early Phase Dose-Finding

Session Details

Brett Thombs
2019 (New Orleans) Annual Meeting

Session Proposal
Development of reporting guidelines for randomized controlled trials using cohorts and routinely collected health data

Session Details

Rhiannon Macefield
2019 (New Orleans) Annual Meeting

Contributed Session
Digital images of surgical wounds taken by patient themselves after leaving hospital: exploring the feasibility of a method for remote and blinded outcome assessment of surgical site infection.

Session Details

Hayat Ahmed
2019 (New Orleans) Annual Meeting

Session Proposal
Diverse Representation in Clinical Trials

Session Details

Yuanxi Jia
2019 (New Orleans) Annual Meeting

Contributed Session
Duplicate Patterns and Duplicate Publication Bias among Chinese-sponsored Drug-related Randomized Controlled Trials

Session Details

Jeremy Wolff
2019 (New Orleans) Annual Meeting

Contributed Session
Electronic Healthcare Record Extraction, Transfer, and Use in Clinical Trials: Lessons Learned

Session Details

Cory Goldstein
2019 (New Orleans) Annual Meeting

Contributed Session
Emergency research without consent: an ethical analysis of the ketamine versus haloperidol trial

Session Details

Jianrong Zhang
2019 (New Orleans) Annual Meeting

Contributed Session
Endpoint Surrogacy in Oncological Randomized Controlled Trials with Immunotherapies: A Systematic Review of Meta-analyses

Session Details

yves rosenberg
2019 (New Orleans) Annual Meeting

Educational Session
Essentials of Clinical Trials

Session Details

Lori Dodd
2019 (New Orleans) Annual Meeting

Contributed Session
Establishment of Good Clinical Data Management Practices for a Randomized Clinical Trial during an Ebola Outbreak

Session Details

Victoria Shepherd
2019 (New Orleans) Annual Meeting

Contributed Session
Ethical aspects of surrogate decision-making for clinical trials: a systematic review of empirical research

Session Details

Madeleine Organ
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluating performance of covariate-constrained randomization (CCR) techniques under misspecification of cluster-level variables

Session Details

Elizabeth Ryan
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluation of Bayesian adaptive designs for Phase III trials

Session Details

Anne Welhaven
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluation of Continual Reassessment Method with Lagged Cohort

Session Details

Khalif Halani
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluation of new methods for valid inference in the presence of selection bias

Session Details

Elizabeth Louise Turner Turner
2019 (New Orleans) Annual Meeting

Contributed Session
Evaluation of weighting and imputation methods to deal with missing outcomes in cluster randomized trials

Session Details

Kehao Zhu
2019 (New Orleans) Annual Meeting

Contributed Session
Evolving Practices of Results Reporting in ClinicalTrials.gov

Session Details

Tracy Wolbach
2019 (New Orleans) Annual Meeting

Contributed Session
Expediting New HIV Therapy to the Market through Collaboration with a Contract Research Organization

Session Details

Samiha Islam
2019 (New Orleans) Annual Meeting

Contributed Session
Experience in Implementing a Genomic Test Screening Tool as a Patient Identification Aid in a Precision Medicine Oncology Study

Session Details

Paula Darby Lipman
2019 (New Orleans) Annual Meeting

Contributed Session
EXPLORING CHALLENGES ASSOCIATED WITH EARLY IMPLEMENTATION OF LOW-COST PRAGMATIC TRIALS

Session Details

Jenny Donovan
2019 (New Orleans) Annual Meeting

Contributed Session
Exploring the translation of the UK QRI (QuinteT Recruitment Intervention) to improve and optimise recruitment to clinical trials in the US

Session Details

Phyllis Goodman
2019 (New Orleans) Annual Meeting

Contributed Session
Extending Randomized Clinical Trial Results through Database Linkages

Session Details

KyungMann Kim
2019 (New Orleans) Annual Meeting

Session Proposal
Founders of the Society for Clinical Trials, Inc.

Session Details

Claire Cochran
2019 (New Orleans) Annual Meeting

Session Proposal
From Grant to GANNT, the challenges of setting up a trial in 2018 – lessons learnt for the international stage

Session Details

Matthew Parkes
2019 (New Orleans) Annual Meeting

Contributed Session
Futility of the Treatment, Rather than Futility of the Trial, as the Primary Focus of Interim Analyses in Clinical Trials

Session Details

Bert Arevalo
2019 (New Orleans) Annual Meeting

Contributed Session
GCP Compliance Challenges in Complementary and Alternative Medicine Trials

Session Details

Geng Li
2019 (New Orleans) Annual Meeting

Contributed Session
Graphical Displays of Patient-Reported Outcomes in Interim Clinical Trial Data Monitoring Committee Reports

Session Details

Michael Grayling
2019 (New Orleans) Annual Meeting

Contributed Session
Historical and contemporary opinions on the design of phase II oncology trials

Session Details

Katie Gillies
2019 (New Orleans) Annual Meeting

Session Proposal
How can behavioural science help us design better trials?

Session Details

Loïc Lebellec
2019 (New Orleans) Annual Meeting

Contributed Session
How to quantify the treatment effect in oncology randomized clinical trials with interval-censored data? Restricted Mean Survival Time Difference versus Hazard Ratio and point estimates: results from a simulation study.

Session Details

Logan Sirline
2019 (New Orleans) Annual Meeting

Contributed Session
Implementation of an Innovative Lab Kit and Bio-Sample Specimen Tracking Module within a Clinical Trial Management System

Session Details

Victoria Trapani
2019 (New Orleans) Annual Meeting

Contributed Session
Implementation of Brain Imaging in the Epidemiology of Diabetes Interventions and Complications Study

Session Details

Chris Cook
2019 (New Orleans) Annual Meeting

Contributed Session
Improving Online Tools for Clinical Trial Design

Session Details

Marie Kay
2019 (New Orleans) Annual Meeting

Contributed Session
Improving Risk, Safety, and Data Integrity Oversight through Standardized Protocol Deviation Management – A Data Coordinating Center’s Approach

Session Details

Lawrence Ragard
2019 (New Orleans) Annual Meeting

Contributed Session
IMPROVING TRANSPARENCY IN CLINICAL TRIAL COSTS FOR PARTICIPANTS: NATIONAL CANCER INSTITUTE (NCI) NATIONAL COVERAGE ANALYSIS INITIATIVE SUPPORTED BY THE NCI’S CANCER TRIALS SUPPORT UNIT

Session Details

Jessica Tran
2019 (New Orleans) Annual Meeting

Contributed Session
Inclusion of Limited English Proficient Individuals in Clinical Research

Session Details

Marcus Johnson
2019 (New Orleans) Annual Meeting

Contributed Session
Increasing Access to Clinical Research Using an Innovative Mobile Recruitment Approach: The (MoRe) Concept

Session Details

Nancy Dianis
2019 (New Orleans) Annual Meeting

Contributed Session
Incremental implementation of risk-based monitoring in a resource-constrained environment

Session Details

Kimberley Goldsmith
2019 (New Orleans) Annual Meeting

Contributed Session
Independent treatment mechanisms of cognitive behavioural treatments for Irritable Bowel Syndrome

Session Details

Mary Pautler
2019 (New Orleans) Annual Meeting

Contributed Session
Information Sharing through an Interactive Process Map

Session Details

Lauren Bradley
2019 (New Orleans) Annual Meeting

Contributed Session
Innovative Application of the Jira Software Technology in the Clinical Trial Case Report Form Development Process

Session Details

Gareth Griffiths
2019 (New Orleans) Annual Meeting

Contributed Session
Innovative digital recruitment and retention tools for more efficient conduct of randomised trials

Session Details

Chenguang Wang
2019 (New Orleans) Annual Meeting

Session Proposal
Innovative Early Phase Clinical Trial Designs for Cancer Immunotherapy

Session Details

RANI JAYSWAL
2019 (New Orleans) Annual Meeting

Contributed Session
Interim Monitoring Reports and SAS Macros to Facilitate Reporting and Implementation of Early Phase Clinical Trials

Session Details

Scott Rushing
2019 (New Orleans) Annual Meeting

Contributed Session
Intervention Adherence Tracking Through Use of an Electronic Participant Engagement Platform

Session Details

sally Jo zuspan
2019 (New Orleans) Annual Meeting

Session Proposal
Introduction to Quality by Design and Risk Management: Can you get your staff and study teams to bite?

Session Details

Katie Gillies
2019 (New Orleans) Annual Meeting

Contributed Session
Investigating Clinical Trial Consultations for Discussions of Retention: A Mixed Methods Study

Session Details

Jessica Overbey
2019 (New Orleans) Annual Meeting

Contributed Session
IS CORRECTING FOR MULTIPLE TESTING NECESSARY IN A PLATFORM TRIAL?

Session Details

Katie Minichiello
2019 (New Orleans) Annual Meeting

Contributed Session
Is Pre-Screening a Good Option for Master Protocols? The Lung-MAP Story

Session Details

Andrew Cook
2019 (New Orleans) Annual Meeting

Contributed Session
Is there an inverse relationship between the importance of a research question and the scientific quality of a proposal to answer it? A reassurance for the UK's Public Health Research programme.

Session Details

Laura Lovato
2019 (New Orleans) Annual Meeting

Educational Session
It Takes a Village: Multi-Disciplinary Approach to Designing Stellar Data Collection Forms

Session Details

Jemma Hudson
2019 (New Orleans) Annual Meeting

Contributed Session
Joint modelling of quality of life and time-to-event data in an orthopaedic trial

Session Details

Rick Chappell
2019 (New Orleans) Annual Meeting

Contributed Session
Just-in-Time Consent: Efficiency vs. Ethics

Session Details

Yuanxi Jia
2019 (New Orleans) Annual Meeting

Contributed Session
Language Bias among Chinese-sponsored Drug-related Randomized Controlled Trials

Session Details

Jérôme Tanguy
2019 (New Orleans) Annual Meeting

Contributed Session
Learnings from the Adaptive Design journey

Session Details

Jessica Tran
2019 (New Orleans) Annual Meeting

Contributed Session
Legal and Ethical Considerations for the Inclusion of Limited English Proficient Individuals in Clinical Research: A Literature Review

Session Details

Cathryn Rankin
2019 (New Orleans) Annual Meeting

Contributed Session
Maintaining a Vigilance for Quality Data

Session Details

Richard Emsley
2019 (New Orleans) Annual Meeting

Contributed Session
Mediation analysis of complex interventions should reflect the trial design

Session Details

Eleanor Murray
2019 (New Orleans) Annual Meeting

Educational Session
Methods for Causal Inference from Randomized Trials with Loss to Follow-up or Non-adherence

Session Details

Laura Morrison
2019 (New Orleans) Annual Meeting

Contributed Session
Minimization as a Randomization Method

Session Details

Thomas Cook
2019 (New Orleans) Annual Meeting

Contributed Session
Missing Data and Sensitivity Analysis with Implications for Sample Size and Power of Randomized Clinical Trials.

Session Details

Kerenza Hood
2019 (New Orleans) Annual Meeting

Contributed Session
Moving innovations in neurofeedback in Mental Health into clinical care: developing a framework to enhance translation

Session Details

Isabelle Weir
2019 (New Orleans) Annual Meeting

Contributed Session
Multivariate meta-analysis model for the difference in restricted mean survival times

Session Details

Yuanyuan Kong
2019 (New Orleans) Annual Meeting

Contributed Session
Novel Mode and Effectiveness of International Collaborative Clinical Research Training Programs among Chinese Physicians

Session Details

Gurbakhshash Singh
2019 (New Orleans) Annual Meeting

Contributed Session
On Covariate Adaptive Randomization Methods in Acute Stroke Trials

Session Details

J Athene Lane
2019 (New Orleans) Annual Meeting

Contributed Session
Optimising recruitment in clinical trials in surgery including strategies for surgical trainees working together to achieve success

Session Details

Marcus Johnson
2019 (New Orleans) Annual Meeting

Contributed Session
Optimization of a Shared Network Drive to Increase Utilization Efficiency in a Clinical Research Setting

Session Details

Jennifer Gassman
2019 (New Orleans) Annual Meeting

Contributed Session
Optimizing data capture and management for tolerability outcomes: The BASE Study

Session Details

Rhiannon Macefield
2019 (New Orleans) Annual Meeting

Contributed Session
Outcome selection and reporting for innovative surgical procedures and devices: a review of current practice in IDEAL/IDEAL-D studies to inform the development of a core outcome set

Session Details

Patty Davis
2019 (New Orleans) Annual Meeting

Contributed Session
PARTICIPANT-DIRECTED DATA ENTRY VIA iPad IN SINGLE AND MULTI-SITE CLINICAL TRIALS

Session Details

Sarah Bruschi
2019 (New Orleans) Annual Meeting

Contributed Session
PERFORMING ELIGIBILITY CHECKS FOR COMPLICATED SCENARIOS

Session Details

Lauren Yesko
2019 (New Orleans) Annual Meeting

Session Proposal
Perspectives on Data Sharing: Preparing, Analyzing, and Conducting Secondary Data Analyses using Publicly Available Clinical Trial Data

Session Details

yves rosenberg
2019 (New Orleans) Annual Meeting

Session Proposal
Planning and Implementing Key Design Changes in Multicenter Clinical Trials: Lessons Learned from the ISCHEMIA trial experience

Session Details

David Kerr
2019 (New Orleans) Annual Meeting

Contributed Session
Points of Consideration for the Independence of DMCs and SDACs

Session Details

Linda Harrison
2019 (New Orleans) Annual Meeting

Contributed Session
Power Calculation for Cross-Sectional Stepped Wedge Cluster Randomized Trials with Variable Cluster Sizes

Session Details

Jennifer Le-Rademacher
2019 (New Orleans) Annual Meeting

Contributed Session
Practical Considerations for Trial Design using the Mean Survival Time Endpoint

Session Details

Sarah Tanveer
2019 (New Orleans) Annual Meeting

Contributed Session
Pragmatic Clinical Trials in Headache and Migraine Research: A Scoping Review

Session Details

Jill Fikowski
2019 (New Orleans) Annual Meeting

Contributed Session
Pre-implementation of a multi-center, Phase IV, Investigator initiated clinical trial: Experiences from the Canadian Research Initiative in Substance Misuse

Session Details

Eve Jelstrom
2019 (New Orleans) Annual Meeting

Contributed Session
Premature Site Closure during a Multi-site Clinical Trial

Session Details

Janel Barnes
2019 (New Orleans) Annual Meeting

Session Proposal
Preparing and Submitting Data to Open and Limited-Access Repositories

Session Details

Wentao Li
2019 (New Orleans) Annual Meeting

Contributed Session
Problematic registration, randomization, and analysis in randomized controlled trials: systematic review of Obstetrics and Gynaecology studies from an African country (2013-2018)

Session Details

Julia Collins
2019 (New Orleans) Annual Meeting

Contributed Session
Procedural Considerations for the Secure Remote Review of Executed Informed Consent Forms

Session Details

Marie Kay
2019 (New Orleans) Annual Meeting

Contributed Session
Process Mapping RCT Study Start-Up

Session Details

Erich Dress
2019 (New Orleans) Annual Meeting

Contributed Session
Prognosticating Outcomes and Nudging Decisions with Electronic Records in the ICU (PONDER-ICU) Trial: Implementation in a learning health system

Session Details

Fei Yuan
2019 (New Orleans) Annual Meeting

Contributed Session
Projecting post-trial life expectancy and life-gained: Using A Markov Microsimulation Model

Session Details

Eleanor Murray
2019 (New Orleans) Annual Meeting

Contributed Session
Proposed guidelines for causal inference from pragmatic randomized trials

Session Details

Lauren Balmert
2019 (New Orleans) Annual Meeting

Contributed Session
Quantile Lost Lifespan: A summary measure for time-to-event data

Session Details

Dustin Rabideau
2019 (New Orleans) Annual Meeting

Contributed Session
Randomization Inference for a Marginal Treatment Effect in Cluster Randomized Trials

Session Details

Patricia Morris
2019 (New Orleans) Annual Meeting

Contributed Session
Re-Enrolling Older Adults Eight Years after Original Study Ended: Issues & Solutions

Session Details

Fatima Alvi
2019 (New Orleans) Annual Meeting

Contributed Session
Reducing Adenoviral Patient Infected Days (RAPID) Study: Success in Masking Subjects and Clinicians to Treatment with Ophthalmic 5% Povidone-Iodine

Session Details

Eric Hardter
2019 (New Orleans) Annual Meeting

Contributed Session
Regulatory considerations for HHS-sponsored, non-drug human subjects research studies

Session Details

Bolaji Egbewale
2019 (New Orleans) Annual Meeting

Contributed Session
Relative sample size reduction of three standard statistical methods in the analysis of randomized controlled trials: a simulation study

Session Details

Melissa Plets
2019 (New Orleans) Annual Meeting

Contributed Session
Rethinking the Traditions of Trial Design: A Rare Cancer Basket Trial as a Motivating Example

Session Details

Hao Zhu
2019 (New Orleans) Annual Meeting

Session Proposal
Role of Model Informed Drug Development (MIDD) in Drug Development and Regulatory Evaluation

Session Details

Marion Campbell
2019 (New Orleans) Annual Meeting

Session Proposal
ROLE OF THE EXPERTISE-BASED DESIGN IN TRIALS OF NON-PHARMACOLOGICAL INTERVENTIONS

Session Details

Spencer Hey
2019 (New Orleans) Annual Meeting

Session Proposal
Safeguarding Public and Patient Trust in Pragmatic Trials Without Written Informed Consent

Session Details

Nicholas Seewald
2019 (New Orleans) Annual Meeting

Contributed Session
Sample size considerations for comparing dynamic treatment regimens in a sequentially-randomized trial with a continuous longitudinal outcome

Session Details

Lee Kennedy-Shaffer
2019 (New Orleans) Annual Meeting

Contributed Session
Sample size estimation for stratified individual and cluster randomized trials with binary outcomes

Session Details

David Zahrieh
2019 (New Orleans) Annual Meeting

Contributed Session
Sample size planning in the design of healthcare delivery intervention trials using the symbolic data framework

Session Details

Steven julious
2019 (New Orleans) Annual Meeting

Contributed Session
Sample sizes Group Clinical Trials with a Survival Endpoint - It’s Accrual World

Session Details

Mark Forrest
2019 (New Orleans) Annual Meeting

Contributed Session
Scaling the communication management hurdle: Communications Manager

Session Details

Julia Collins
2019 (New Orleans) Annual Meeting

Educational Session
Site Selection for Clinical Trials: Tips, Tricks and Process Considerations

Session Details

John Nichols
2019 (New Orleans) Annual Meeting

Contributed Session
SITE TRACKING SYSTEM FOR ADMINISTRATION AND ORGANIZATION OF CLINICAL SITE-SPECIFIC INFORMATION

Session Details

Thomas Cook
2019 (New Orleans) Annual Meeting

Contributed Session
Statistical Approaches for Summarizing the Clinical Event Reporting and Adjudication Process.

Session Details

Jody Ciolino
2019 (New Orleans) Annual Meeting

Educational Session
Statistical Concepts in Clinical Trials for Non-Statisticians

Session Details

Lu Mao
2019 (New Orleans) Annual Meeting

Contributed Session
Statistical Inference for Complex Time to Event Outcomes under Non-Randomized Cohorts with Application to the INVESTED Trial

Session Details

Leila Rooshenas
2019 (New Orleans) Annual Meeting

Educational Session
Strategies for optimizing recruitment to randomized clinical trials

Session Details

Margaret Crawford
2019 (New Orleans) Annual Meeting

Contributed Session
Surmounting Barriers with Targeted Solutions: Launching the Pharmacotherapies for Alcohol and Substance Abuse Consortium

Session Details

Victoria Shepherd
2019 (New Orleans) Annual Meeting

Contributed Session
Surrogate decision-making for clinical trials: a qualitative exploration of surrogate decision-makers’ experiences

Session Details

Julie Qidwai
2019 (New Orleans) Annual Meeting

Session Proposal
Switching Boats Mid-Stream: Maintaining Continuity in a Large Clinical Trials Network in the Face of Change

Session Details

Clement Ma
2019 (New Orleans) Annual Meeting

Contributed Session
TARGET-CRM: a novel adaptive dose-escalation design for targeted therapies with applications in pediatric oncology

Session Details

Fei Chen
2019 (New Orleans) Annual Meeting

Contributed Session
Testing of Multiple Survival Endpoints in a Group Sequential Design – Control of Familywise Error in CREDENCE

Session Details

Nicole Edgar
2019 (New Orleans) Annual Meeting

Contributed Session
The BEACON Study: Protocol for a cohort study as part of an evaluation of the effectiveness of smartphone-assisted problem solving therapy in men who present with intentional self-harm to Emergency Departments in Ontario.

Session Details

Catherine Olivier
2019 (New Orleans) Annual Meeting

Contributed Session
The Challenge of Innovation: Considerations for implementing two-way text messaging for primary outcome data collection in clinical trials

Session Details

Amy Dwy
2019 (New Orleans) Annual Meeting

Session Proposal
THE COLLABORATION BETWEEN DATA MANAGERS AND MONITORS IN RISK BASED MONITORING IN INTERNATIONAL STUDIES

Session Details

Charles Opondo
2019 (New Orleans) Annual Meeting

Contributed Session
The Combined Protocol for Acute Malnutrition Study: a cluster randomized non-inferiority trial in Kenya and South Sudan

Session Details

David DeMets
2019 (New Orleans) Annual Meeting

Session Proposal
The Coronary Drug Project (CDP): Looking Back 50 Years

Session Details

Adelaide Doussau
2019 (New Orleans) Annual Meeting

Contributed Session
The Ethics of Placebo Sequential Parallel Comparison Design

Session Details

Greg Ball
2019 (New Orleans) Annual Meeting

Session Proposal
The Global Regulatory Landscape and a Safety Mindset: Medical Judgment and Decision-Making within a Quantitative Framework

Session Details

Brooke Maracle
2019 (New Orleans) Annual Meeting

Contributed Session
The Influence of Institution Accrual on Patient Survival in Canadian Cancer Clinical Trials

Session Details

Catherine Meyers
2019 (New Orleans) Annual Meeting

Session Proposal
The Landscape of Embedded Pragmatic Clinical Trials in the US: Focus on Opioid Use and Pain Management

Session Details

Melanie Bell
2019 (New Orleans) Annual Meeting

Contributed Session
The mixed model for repeated measures for cluster randomized trials (MMRM-CRT): a simulation study investigating bias and type I error with missing continuous data

Session Details

Karla Hemming
2019 (New Orleans) Annual Meeting

Session Proposal
The multiple-period cluster randomised cross-over design for comparative effectiveness research: statistical and ethical issues

Session Details

Krista Valladares
2019 (New Orleans) Annual Meeting

Contributed Session
The NeuroNEXT Model: Efficiencies Gained by Deploying an Embedded Research Administrator

Session Details

Jonathan Kimmelman
2019 (New Orleans) Annual Meeting

Session Proposal
The United States’ Right-To-Try Legislation: Implications for Clinical Trials

Session Details

ken cheung
2019 (New Orleans) Annual Meeting

Session Proposal
Training the future generation of clinical trial biostatisticians

Session Details

Claire Cochran
2019 (New Orleans) Annual Meeting

Contributed Session
Traumatic Decisions; Research Recruitment and Randomisation in an Acute Emergency Setting

Session Details

Alison McDonald
2019 (New Orleans) Annual Meeting

Educational Session
Trial Close 0ut and Archiving

Session Details

Rebecca Lewis
2019 (New Orleans) Annual Meeting

Contributed Session
Trial salvage: Pragmatic design adaptation in response to recruitment challenges

Session Details

Edward Mayerson
2019 (New Orleans) Annual Meeting

Contributed Session
Trials, Tribulations, and Triumphs in Coordinating a “Not Otherwise Categorized” Cohort in an Umbrella Trial for Rare Cancers

Session Details

Rob Basmadjian
2019 (New Orleans) Annual Meeting

Contributed Session
UGT2B17, exemestane metabolism, and their association with physical health-related quality of life in postmenopausal women participating in the Mammary Prevention 3 Trial

Session Details

Peter Kaufmann
2019 (New Orleans) Annual Meeting

Session Proposal
Unintended consequences of participant engagement in clinical trials involving behavioral interventons.

Session Details

Giulia Lorenzoni
2019 (New Orleans) Annual Meeting

Contributed Session
Use of wearable devices to monitor physical activity in clinical studies: the CAPABILITY study protocol

Session Details

Jeffrey McCrindle
2019 (New Orleans) Annual Meeting

Contributed Session
Using AI and Natural Language Generation to Automate Pharmaceutical Clinical Study Reports

Session Details

Maria Pufulete
2019 (New Orleans) Annual Meeting

Session Proposal
Using observational healthcare data to emulate randomized trials

Session Details

Shaun Treweek
2019 (New Orleans) Annual Meeting

Educational Session
Using Studies Within a Trial (SWATs) to increase the evidence base for trial process decision-making

Session Details

David Klements
2019 (New Orleans) Annual Meeting

Contributed Session
Utilizing cloud-based software to increase efficiency and reduce errors and increase efficiency in communication during the conduct of multi-site clinical trials

Session Details

Kimberley Goldsmith
2019 (New Orleans) Annual Meeting

Session Proposal
What works for whom and why: the future for trials of complex interventions

Session Details

Mahesh Parmar
2018 (Portland) Annual Meeting

Trial of the Year Award
The Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy (STAMPEDE, NCT00268476)

Fan-fan Yu, Kathleen Reape
2018 (Portland) Annual Meeting

Trial of the Year Award
Efficacy and Safety of Voretigene Neparvovec (AAV2-hRPE65v2) in Patients with RPE65-mediated Inherited Retinal Dystrophy

William C. Cushman
2018 (Portland) Annual Meeting

Founders Lecture
Major VA and NHLBI Clinical Trials That Impacted the Management of Hypertension

Susan Halabi
2018 (Portland) Annual Meeting

Fellows Presentation
Presentation of the Class of 2018 Fellows

James J. Dignam
2018 (Portland) Annual Meeting

Award Presentation
Thomas C. Chalmers Scholarship and Sylvan Green Awards

Steven Goodman
2018 (Portland) Annual Meeting

Curtis Meinert Lecture
Research reproducibility and research reform: lessons from clinical trials

Ted Karrison, PhD
2018 (Portland) Annual Meeting

Presidential Welcome
Welcome - 2017-18 SCT President

Nicola Mills
2018 (Portland) Annual Meeting

Session Proposal
Achieving the impossible? Case studies of successful recruitment to randomised clinical trials considered contentious or impossible

Session Details

Theodore Lystig
2018 (Portland) Annual Meeting

Session Proposal
Dynamic determination of a power prior parameter – the discount prior approach

Session Details

Roger J. Lewis
2018 (Portland) Annual Meeting

Session Proposal
Design of an Adaptive Trial of Extra-Corporeal Membrane Oxygenation for Refractory Out-of-hospital Cardiac Arrest (EROCA)

Session Details

Lehana Thabane
2018 (Portland) Annual Meeting

Session Proposal
In memory of Dave Sackett: Interim data sharing by data safety monitoring boards of trials (Alternative title: Dave Sackett’s last project on interim data sharing by DSMBs of trials)

Session Details

Catherine Dillon
2018 (Portland) Annual Meeting

Session Proposal
Optimizing investigational drug management to enhance clinical trial operation quality

Session Details

Jeremy Grimshaw
2018 (Portland) Annual Meeting

Session Proposal
Developing a framework for the ethical design and conduct of pragmatic trials: consultation with the clinical trials community

Session Details

Greg Ball
2018 (Portland) Annual Meeting

Session Proposal
Dynamic and Interactive Collaboration between Quantitative and Clinical Scientists: Towards a Better Way of Monitoring and Evaluating Safety Data during Clinical Development

Session Details

Jeremy Grimshaw
2018 (Portland) Annual Meeting

Session Proposal
Introducing the new CONSORT extension for the Stepped-Wedge Cluster Randomised Trial

Session Details

Professor Jeremy Grimshaw
2018 (Portland) Annual Meeting

Session Proposal
Designing Trials within Implementation Laboratories

Session Details

Frank Rockhold
2018 (Portland) Annual Meeting

Session Proposal
Open Sharing of Clinical Trial Data

Session Details

Caitlyn Meinzer
2018 (Portland) Annual Meeting

Session Proposal
Adaptive Timing of Interim Analysis for Primary Efficacy Outcome

Session Details

Kirsty Loudon
2018 (Portland) Annual Meeting

Contributed Session
“Treatment As Usual” as the comparator in Randomised Controlled Trials: A scoping review of the use of the term over the past five years in six international general medical trial journals.

Session Details

Katie Gillies
2018 (Portland) Annual Meeting

Contributed Session
‘It’s trying to manage the work’: a qualitative evaluation of recruitment processes within a UK multicentre trial

Session Details

Sharavi Peeramsetti
2018 (Portland) Annual Meeting

Contributed Session
“Essential data for Data Monitoring Committee (DMC) review – the ideal open and closed session reports”

Session Details

Barry Main
2018 (Portland) Annual Meeting

Contributed Session
“Forget-me-not” – a protocol for a pilot cluster randomised trial to pilot a core information set intervention for informed consent to invasive procedures including surgery

Session Details

Eric Hardter
2018 (Portland) Annual Meeting

Contributed Session
A “compound” problem: general strategies and key resources for the utilization of approved, commercially available drugs in a blinded, controlled clinical trial

Session Details

Boxian Wei
2018 (Portland) Annual Meeting

Contributed Session
A Bayesian Analysis of Small n Sequential Multiple Assignment Randomized Trials (snSMARTs)

Session Details

Graham Wheeler
2018 (Portland) Annual Meeting

Contributed Session
A BAYESIAN MODEL-FREE APPROACH TO COMBINATION THERAPY PHASE I TRIALS USING CENSORED TIME-TO-TOXICITY DATA

Session Details

Julia Collins
2018 (Portland) Annual Meeting

Contributed Session
A Comprehensive Customizable Site Readiness Checklist for Efficient Site Activation in a Clinical Trial

Session Details

Munya Dimairo
2018 (Portland) Annual Meeting

Contributed Session
A consensus-driven reporting guidance for adaptive clinical trials: an Adaptive designs CONSORT Extension (ACE)

Session Details

Xiaobo Zhong
2018 (Portland) Annual Meeting

Contributed Session
A Gate-keeping Test for Selecting Adaptive Interventions under General SMART Designs

Session Details

Beata Planeta
2018 (Portland) Annual Meeting

Contributed Session
A New Approach of Modeling Time in Longitudinal Studies Involving Infrequent and Unequally Spaced Measurements

Session Details

Qinshu Lian
2018 (Portland) Annual Meeting

Contributed Session
A Novel Bayesian Two-stage Design with Dynamic Historical Borrowing Using a Robust Network Meta-analytic-predictive Approach

Session Details

Brian Egleston
2018 (Portland) Annual Meeting

Contributed Session
A novel randomized Phase 2 trial design that constrains sample size by requiring a sufficient experimental response rate

Session Details

Haiyan Zheng
2018 (Portland) Annual Meeting

Contributed Session
A robust Bayesian meta-analytic approach for borrowing information across species in phase I clinical trials

Session Details

Andrew Forbes
2018 (Portland) Annual Meeting

Contributed Session
A simple relationship between power and expected confidence interval width

Session Details

Katherine Fairhurst
2018 (Portland) Annual Meeting

Contributed Session
A systematic analysis of UK nationally-funded surgical pilot and feasibility study protocols from the last 10 years to inform and optimise future surgical trials.

Session Details

Erik Doffagne
2018 (Portland) Annual Meeting

Contributed Session
A Targeted Approach to Medical and Safety Reviews

Session Details

Karla Hemming
2018 (Portland) Annual Meeting

Educational Session
A tutorial on sample size for efficient cluster, cluster cross-over and stepped-wedge randomised trials; including introduction to a practical on-line “app”

Session Details

Michael Grayling
2018 (Portland) Annual Meeting

Contributed Session
A two-stage version of Fisher’s exact test for multi-arm trials with binary outcome variables

Session Details

Kelly Miller
2018 (Portland) Annual Meeting

Contributed Session
A UNIQUE COLLABORATION FOR A DATA COORDINATING CENTER

Session Details

Elizabeth Colantuoni
2018 (Portland) Annual Meeting

Contributed Session
Accounting for baseline prognostic variables and patient drop-out in the analysis of longitudinal outcomes within randomized trials for Alzheimer’s Disease

Session Details

Kelsey Grantham
2018 (Portland) Annual Meeting

Contributed Session
Accounting for measurement times with a non-uniform correlation structure in sample size determination for multiple-period cluster randomised trials

Session Details

Keaton Somerville
2018 (Portland) Annual Meeting

Contributed Session
ACHIEVING PROJECTED DATABASE LOCK IN A MULTI-SITE STUDY - A REPORT FROM A NIDA CTN STUDY

Session Details

Ajar Kochar
2018 (Portland) Annual Meeting

Contributed Session
ADAPTABLE - A Patient-Centered, Pragmatic Randomized Clinical Trial

Session Details

Laura Flight
2018 (Portland) Annual Meeting

Contributed Session
Adaptive Design Clinical Trials and their Impact on the Health Economic Analysis of Healthcare Technologies - A Qualitative Study

Session Details

Christopher S. Coffey
2018 (Portland) Annual Meeting

Educational Session
Adaptive Designs - Overview, Hurdles, & Examples

Session Details

Ben Saville, Ph.D.
2018 (Portland) Annual Meeting

Educational Session
Adaptive Multi-arm Platform Trials

Session Details

Jonathan Chipman
2018 (Portland) Annual Meeting

Contributed Session
Adaptively Monitoring Clinical Trials with Second-Generation p-values

Session Details

Jiajun Wen
2018 (Portland) Annual Meeting

Contributed Session
Adverse events in 103 randomized trials on 1st line glaucoma eye drops

Session Details

Stephanie Wellford
2018 (Portland) Annual Meeting

Contributed Session
All Hands on Deck for Eligibility Checks

Session Details

Chen Hu
2018 (Portland) Annual Meeting

Session Proposal
Alternatives to Conventional Survival Analysis Metrics for Clinical Trials

Session Details

Kandi Velarde
2018 (Portland) Annual Meeting

Contributed Session
An Initiative Using Informatics to Facilitate Clinical Research Planning and Recruitment in the VA Health Care System

Session Details

Jane Candlish
2018 (Portland) Annual Meeting

Contributed Session
Analysis methods for individually randomised trials with partial clustering of outcomes

Session Details

Heidi Christ-Schmidt
2018 (Portland) Annual Meeting

Contributed Session
Analysis of studies when rescue therapy censors data

Session Details

Joseph Rausch
2018 (Portland) Annual Meeting

Contributed Session
Analyzing treatment effects and moderators in randomized pre-post clinical trials

Session Details

Jennifer Le-Rademacher
2018 (Portland) Annual Meeting

Contributed Session
Application of Multi-State Models in Cancer Clinical Trials

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Applying Measurement Science to the Development of Technology-Derived Novel Endpoints for use in Clinical Trials

Session Details

Daniele Bottigliengo
2018 (Portland) Annual Meeting

Contributed Session
Assessing the external validity of Randomized Clinical Trials: inverse probability weighting approaches on type-2 diabetes data

Session Details

Hiroko Dodge
2018 (Portland) Annual Meeting

Contributed Session
Behavioral RCT using frequent social interaction to enhance cognitive reserve

Session Details

Cristina Murray-Krezan
2018 (Portland) Annual Meeting

Contributed Session
BUILDING THE FOUNDATION FOR A STATISTICS AND DATA COORDINATING CENTER WITH LIMITED RESOURCES: THE HERO STUDY, A NATIONWIDE MULTICENTER RANDOMIZED HEPATITIS C TREATMENT TRIAL

Session Details

Benjamin Carlisle
2018 (Portland) Annual Meeting

Contributed Session
BURDEN AND CLINICAL IMPACT OF COMBINATION THERAPY EXPLORATION FOR NEW ANTICANCER DRUGS

Session Details

Adina Stoica
2018 (Portland) Annual Meeting

Contributed Session
Calculating Antiretroviral Drug Resistance: An Innovative Open-Source Tool

Session Details

Rachel Weber
2018 (Portland) Annual Meeting

Contributed Session
CENTRALIZED SOURCE DOCUMENT REVIEW: AN EFFECTIVE TOOL FOR REMOTE REVIEW OF DIGITIZED PAPER SOURCE DOCUMENTS

Session Details

Wendy Seiferheld
2018 (Portland) Annual Meeting

Contributed Session
Challenges and Lessons Learned from Engaging the ClinicalTrials.gov Protocol Registration and Results System (PRS): An NRG Oncology Experience

Session Details

Shelly Lensing
2018 (Portland) Annual Meeting

Contributed Session
Challenges and Successes in Recruitment of HIV Infected Persons to a Cancer Prevention Study

Session Details

Roberta Scherer
2018 (Portland) Annual Meeting

Contributed Session
Challenges in conducting a multi-center trial in US military hospitals

Session Details

Melissa Plets
2018 (Portland) Annual Meeting

Contributed Session
Challenges in Conducting DART (S1609), a Pioneer Basket Trial for Rare Cancers in a Cooperative Group Setting

Session Details

Jeannette Lee
2018 (Portland) Annual Meeting

Contributed Session
Challenges of Conducting a Clinical Trial in Youth Correctional Facilities

Session Details

Andrew Waberski
2018 (Portland) Annual Meeting

Contributed Session
Challenges with Conducting a Trial of Opioid Administration during Anesthesia in Pediatric Patients Undergoing Cardiac Surgery

Session Details

Kehao Zhu
2018 (Portland) Annual Meeting

Contributed Session
Characteristics and trends of industry sponsored clinical trials with a DMC – insights from ClinicalTrials.gov

Session Details

Jody Ciolino
2018 (Portland) Annual Meeting

Contributed Session
Choosing a Balancing Criterion for Complex Cluster-Randomized Trials with Continuous Baseline Variables

Session Details

Rui Wu
2018 (Portland) Annual Meeting

Contributed Session
Classifying No Improvement in Visual Acuity in Children with Amblyopia Using Simulations

Session Details

Barbara H. Braffett
2018 (Portland) Annual Meeting

Session Proposal
Clinical Studies with Long-term Follow-up: Experiences and Lessons Learned

Session Details

Jidong Jia
2018 (Portland) Annual Meeting

Session Proposal
Clinical Trials in China – Opportunities and Challenges for International Collaboration

Session Details

Nisha Grover
2018 (Portland) Annual Meeting

Contributed Session
Collaborative Approach to Conduct User Testing by Non-technical Research Staff

Session Details

GEORGE KITSARAS
2018 (Portland) Annual Meeting

Contributed Session
Collection of real-time data from participants – interactive text surveys

Session Details

Walter Ambrosius
2018 (Portland) Annual Meeting

Contributed Session
Combining SAS and LaTeX for DSMB report generation: The ENRGISE Pilot Study

Session Details

Katherine Guthrie
2018 (Portland) Annual Meeting

Contributed Session
Comparison of mass mailings to Facebook advertising for recruitment of midlife women with bothersome vaginal symptoms

Session Details

Valerie Durkalski-Mauldin
2018 (Portland) Annual Meeting

Session Proposal
Competing with RVUs: How to successfully balance clinical research and clinical practice for the academic clinical principal investigator

Session Details

Taylor Swankie
2018 (Portland) Annual Meeting

Contributed Session
Conducting High-Impact, High-Quality Clinical Trials: Site Staff Training as a Component of Quality

Session Details

Claire Snowdon
2018 (Portland) Annual Meeting

Contributed Session
Conducting Non-commercial Clinical Trials Internationally - Experiences of a UK based Academic Clinical Trials Unit

Session Details

Andrew Forbes
2018 (Portland) Annual Meeting

Session Proposal
Covariate constrained randomisation for the design of parallel and stepped wedge cluster trials

Session Details

Ayon Mukherjee
2018 (Portland) Annual Meeting

Contributed Session
Covariate-Adjusted Response-Adaptive Designs for Weibull Distributed Survival Responses

Session Details

Li Chen
2018 (Portland) Annual Meeting

Session Proposal
Current Development of Adaptive Designs in Clinical Trials

Session Details

Andrew Forbes
2018 (Portland) Annual Meeting

Contributed Session
Decomposition of the treatment effect estimator in stepped wedge trials: Understanding the horizontal and vertical contributions

Session Details

Ludovic Trinquart
2018 (Portland) Annual Meeting

Contributed Session
Design Analyses of Randomized Clinical Trials Supporting FDA Cancer Drug Approvals

Session Details

Amanda Farrin
2018 (Portland) Annual Meeting

Educational Session
Design and Conduct of Efficient, Innovative Pilot & Feasibility Studies for Complex Interventions

Session Details

Jonathan Cook
2018 (Portland) Annual Meeting

Contributed Session
Design and optimal use of the expertise-based randomised controlled trial design

Session Details

Keith Pauls
2018 (Portland) Annual Meeting

Contributed Session
Design of an Electronic cIRB Submission Module Integrated Within a Clinical Trial Management System

Session Details

Isabelle Weir
2018 (Portland) Annual Meeting

Contributed Session
Design of Non-inferiority Randomized Trials Using the Difference in Restricted Mean Survival Times

Session Details

Lynn Sleeper
2018 (Portland) Annual Meeting

Contributed Session
DESIGN OF THE TEAMMATE TRIAL FOR CHILDREN WITH HEART TRANSPLANT AND DEVELOPMENT OF A NOVEL EFFICIENT ENDPOINT

Session Details

Lydia Foster
2018 (Portland) Annual Meeting

Contributed Session
Designing a Non-Inferiority Trial: Bayesian versus Frequentist Approach

Session Details

Jan Jansen
2018 (Portland) Annual Meeting

Contributed Session
Designing efficient trials in major trauma: the case study of REBOA

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Designing study protocols when mobile devices are used for data capture: Recommendations from the Clinical Trials Transformation Initiative

Session Details

Hakim-Moulay Dehbi
2018 (Portland) Annual Meeting

Contributed Session
Designing two- or three-arm randomized phase 2 selection trials using a margin of practical equivalence

Session Details

Jamie Jackson
2018 (Portland) Annual Meeting

Contributed Session
Determining Wear Time Validation Algorithms and Cutpoints: Challenges to Using Accelerometry in a Behavioral Randomized Clinical Trial of Adolescents with Congenital Heart Disease

Session Details

Heather Murray
2018 (Portland) Annual Meeting

Contributed Session
Developing a Remote Statistical Monitoring Plan

Session Details

Kaleab Abebe
2018 (Portland) Annual Meeting

Contributed Session
Development and implementation of a web-based SAE adjudication system.

Session Details

Kerry Avery
2018 (Portland) Annual Meeting

Contributed Session
Development of a core outcome set capturing key concepts relevant to safe and efficient evaluation of innovative invasive procedures

Session Details

Diane Whitham
2018 (Portland) Annual Meeting

Contributed Session
Development of a standardised set of metrics for monitoring site performance in multicentre randomised trials: a mixed methods study

Session Details

Wendy Lawton
2018 (Portland) Annual Meeting

Contributed Session
Digital Strategies for Making Clinical Trials More Accessible: SWOG’s Website Redesign

Session Details

Mathew Margolis
2018 (Portland) Annual Meeting

Contributed Session
Do Site Visits Improve Participant Re-Engagement In Longitudinal Clinical Research?

Session Details

Clement Ma
2018 (Portland) Annual Meeting

Contributed Session
Dual-agent dose escalation methods for pediatric oncology clinical trials

Session Details

Ashley Hogan
2018 (Portland) Annual Meeting

Contributed Session
DYNAMIC MANUSCRIPT DEVELOPMENT AND TRACKING OF SCIENTIFIC PRODUCTIVITY AND IMPACT

Session Details

Zhibao Mi
2018 (Portland) Annual Meeting

Contributed Session
Empirical Assessment of Trial Futility in Multicenter Clinical Trials

Session Details

Carol Knott
2018 (Portland) Annual Meeting

Educational Session
Engaging ‘tricky’ sites: hints and tips

Session Details

Sangeetha Paramasivan
2018 (Portland) Annual Meeting

Contributed Session
Ethical aspects of clinical trials in India: a systematic review of research in the past two decades

Session Details

Cory Goldstein
2018 (Portland) Annual Meeting

Contributed Session
Ethical implications for pragmatic trials involving head-to-head comparisons of usual care interventions: an ethical analysis of the MINT trial

Session Details

Ralph Trane
2018 (Portland) Annual Meeting

Contributed Session
Evaluation of Diabetic Retinopathy Using the ETDRS Severity Scale – Is There A Gold Standard?

Session Details

Kimberley Goldsmith
2018 (Portland) Annual Meeting

Contributed Session
Evidenced based refinement of treatments – building mechanism evaluation into clinical trials

Session Details

Nicola Greenlaw
2018 (Portland) Annual Meeting

Contributed Session
Expanding on accepted wisdoms of statistical design and analysis - stratified randomized controlled trials

Session Details

Katie Gillies
2018 (Portland) Annual Meeting

Contributed Session
Exploring retention in clinical trials: A meta-ethnographic synthesis of studies reporting participant reasons for drop out

Session Details

Michelle Collinson
2018 (Portland) Annual Meeting

Contributed Session
EXPLORING THE HAWTHORNE EFFECT USING A BALANCED INCOMPLETE BLOCK DESIGN IN THE ASPIRE CLUSTER RANDOMISED CONTROLLED TRIALS

Session Details

Zhaomian Li
2018 (Portland) Annual Meeting

Contributed Session
Exploring the Impact of the False Discovery Rate to Correct for Multiple Comparisons

Session Details

Laura Lovato
2018 (Portland) Annual Meeting

Contributed Session
Exploring the potential of clinical trial data sharing: The SPRINT Challenge

Session Details

Loretta Davies
2018 (Portland) Annual Meeting

Contributed Session
Exploring treatment preference in trials which compare very different interventions: a pre-trial qualitative study

Session Details

Wynne Norton
2018 (Portland) Annual Meeting

Contributed Session
Extension of the PRECIS-2 tool to assist in planning trials of multi-level interventions

Session Details

Mallory Hacker
2018 (Portland) Annual Meeting

Contributed Session
Feasibility of a Seven-Day Therapeutic Washout in Early Stage Parkinson’s Disease

Session Details

Kaitlyn Cook
2018 (Portland) Annual Meeting

Contributed Session
Futility Assessment via the Conditional Power for Cluster-Randomized Trials with Time-to-Event Endpoints

Session Details

Melissa Schultz
2018 (Portland) Annual Meeting

Contributed Session
Graphical Summaries of Trial Conduct in DMC Reports

Session Details

Kristen Mason
2018 (Portland) Annual Meeting

Contributed Session
Heat Maps for Database Lock

Session Details

Heidi Gardner
2018 (Portland) Annual Meeting

Contributed Session
How do trialists go about designing their recruitment strategies? A qualitative interview study with trial stakeholders

Session Details

Allison Hirst, IDEAL Project Manager & Researcher
2018 (Portland) Annual Meeting

Educational Session
How to use IDEAL (Idea, Development, Exploration, Assessment and Long-term study) to improve surgical innovation research

Session Details

Asha Khachane
2018 (Portland) Annual Meeting

Contributed Session
IDEAL: Framework and Recommendations for Evaluation of Surgical Innovations

Session Details

Jody Ciolino
2018 (Portland) Annual Meeting

Contributed Session
Ideas in Randomization Methods for Complex Cluster-Randomized Trials

Session Details

Garrick Wallstrom
2018 (Portland) Annual Meeting

Contributed Session
Identification of High-efficacy Subgroups in Clinical Trials

Session Details

Rebecca Simpson
2018 (Portland) Annual Meeting

Contributed Session
Identifying subgroups of children with asthma who are at higher risk of having an unscheduled medical contact in September: A mixed methods study

Session Details

Thevaa Chandereng
2018 (Portland) Annual Meeting

Contributed Session
Imbalanced

Session Details

Erik Doffagne
2018 (Portland) Annual Meeting

Contributed Session
Implementing a Scalable Risk-Based Monitoring Strategy

Session Details

Lauren Yesko
2018 (Portland) Annual Meeting

Contributed Session
Implementing eCRFs in an Emergency Department environment: challenges, enhancements, and lessons learned

Session Details

Jeremy Wolff
2018 (Portland) Annual Meeting

Contributed Session
Implementing Standardized Assessments in EDC: Benefits and Challenges based on Experience of Integrating the PhenX Toolkit into a Clinical Trials Network

Session Details

Paul Brocklehurst
2018 (Portland) Annual Meeting

Contributed Session
Improving implementation in Wales through 'The Forum': an update

Session Details

Sian Cousins
2018 (Portland) Annual Meeting

Contributed Session
Improving RCTs in invasive procedures; a proposed new definition of invasive procedures

Session Details

Shaun Treweek
2018 (Portland) Annual Meeting

Contributed Session
Improving the evidence base for trial process decision-making: Studies Within A Trial (SWAT) and why we should be coordinating and doing more of them

Session Details

Dr. Marjorie Jenkins
2018 (Portland) Annual Meeting

Session Proposal
Including Pregnant and Lactating Women in Clinical Trials: Controversies, Challenges and Opportunities

Session Details

Victoria Trapani
2018 (Portland) Annual Meeting

Contributed Session
Incorporating Aging Measures in a Long-term Multicenter Observational Study: Training and Certification Procedures

Session Details

Colin Begg
2018 (Portland) Annual Meeting

Session Proposal
Informed Consent and Innovative Trial Designs

Session Details

Allison Furey
2018 (Portland) Annual Meeting

Contributed Session
Innovative Use of Stacked Area Plots in DMC Reporting

Session Details

Wenle Zhao
2018 (Portland) Annual Meeting

Contributed Session
Integrated Drug Tracking Module in EDC-CTMS for Operation Quality Assurance in a Large Multicenter Trial

Session Details

Jaemyung Kim
2018 (Portland) Annual Meeting

Contributed Session
Integrating Neuroimaging Central Repository and Tracking in Clinical Trial Management System

Session Details

Brian Burke
2018 (Portland) Annual Meeting

Contributed Session
Integrating New Site Coordinators in an Ongoing Long-Term Multi-Site Observational Trial

Session Details

Michael Frasketi
2018 (Portland) Annual Meeting

Contributed Session
Interactive Reporting and Visualization of Standardized Clinical Data

Session Details

Toshimitsu Hamasaki
2018 (Portland) Annual Meeting

Contributed Session
Interim evaluation of efficacy or futility in group-sequential trials with two time-to-event outcomes

Session Details

Brett Hanscom
2018 (Portland) Annual Meeting

Contributed Session
Interim Monitoring using Adaptive, Time-Varying Non-Inferiority Margins

Session Details

Katie Gillies
2018 (Portland) Annual Meeting

Contributed Session
Interventions to improve retention to clinical trials: a behavioural analysis of effective interventions.

Session Details

Stephen Nash
2018 (Portland) Annual Meeting

Contributed Session
Introducing a new Stata package for sample size calculation in trials where the outcome is a rate

Session Details

Jimmy Le
2018 (Portland) Annual Meeting

Contributed Session
Is intraocular pressure, a surrogate outcome, important to patients with glaucoma?

Session Details

Dixie Ecklund
2018 (Portland) Annual Meeting

Session Proposal
Keeping Your Eye on the Endpoints: Study Closeout Starts from the Beginning

Session Details

Heather Kopetskie
2018 (Portland) Annual Meeting

Contributed Session
Leveraging Existing Databases for Clinical Trial Data

Session Details

Sudha Raman
2018 (Portland) Annual Meeting

Contributed Session
Leveraging the Electronic Health Record in a Global Outcomes Trial: Design and Rationale of the HARMONY Outcomes EHR Ancillary

Session Details

Gail Mallett
2018 (Portland) Annual Meeting

Contributed Session
Maternal Characteristics Associated with Consent and Reasons for Refusal in a Randomized Controlled Trial in Pregnancy

Session Details

Denise Esserman
2018 (Portland) Annual Meeting

Contributed Session
MEASURING THE IMPACT OF PATIENT PREFERENCE IN CLINICAL TRIALS

Session Details

Michael Frasketi
2018 (Portland) Annual Meeting

Contributed Session
Medical Image Integration with Clinical Research Systems

Session Details

Virginia Howard
2018 (Portland) Annual Meeting

Contributed Session
Methods, Successes, and Lessons Learned from Centralized Cognitive Assessment in a Multicenter Clinical Trial of Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis (CREST-2)

Session Details

Fang-Shu Ou
2018 (Portland) Annual Meeting

Contributed Session
Milestone prediction for time-to-event endpoint monitoring in clinical trials

Session Details

Brooke Rabe
2018 (Portland) Annual Meeting

Contributed Session
Missing data imputation methods in non-inferiority trials: a simulation study

Session Details

Elaine Pascoe
2018 (Portland) Annual Meeting

Contributed Session
MISSING DATA IN THE COMPONENTS OF A BINARY COMPOSITE ENDPOINT: IMPLICATIONS FOR THE COMPOSITE

Session Details

Virginia Nido
2018 (Portland) Annual Meeting

Contributed Session
MOBILE TECHNOLOGY AND CLINICAL TRIALS: PATIENT PERSPECTIVES AND OPPORTUNITIES TO REDUCE THE BURDEN OF PARTICIPATION

Session Details

Danni Liu
2018 (Portland) Annual Meeting

Contributed Session
Modeling Correlated Ocular Outcomes when Both Eyes from Some but Not All Participants are Enrolled

Session Details

Brian Burke
2018 (Portland) Annual Meeting

Contributed Session
Monitoring and Adjudication of Comorbidities in a Multi-Center Observational Study of Youth with Type 2 Diabetes

Session Details

Jennifer Gassman
2018 (Portland) Annual Meeting

Contributed Session
Monitoring and Reporting blood pressure data quality and data completeness and blood pressure treatment arm separation for the Blood Pressure in Dialysis (BID) Pilot Study

Session Details

Jason McCoy
2018 (Portland) Annual Meeting

Contributed Session
Monitoring Interactive Response Technology Vendor Implemented Randomization and Dosing Systems

Session Details

Anna Bowers
2018 (Portland) Annual Meeting

Contributed Session
MONITORING OF MEDICAL EVENTS AND ADJUDICATION THROUGH CUSTOMIZABLE DIGITAL WORKFLOWS IN THE DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

Session Details

Haley Hedlin
2018 (Portland) Annual Meeting

Contributed Session
Monitoring rare events during an ongoing clinical trial

Session Details

Stacey Slone
2018 (Portland) Annual Meeting

Contributed Session
My Data, Your Data, Where’s the Data?

Session Details

Jonathan Cook
2018 (Portland) Annual Meeting

Contributed Session
New guidance on specifying the target difference (“effect size”) for a RCT

Session Details

Claire Boyle
2018 (Portland) Annual Meeting

Contributed Session
NHANES as a Comparator Cohort

Session Details

Ying Yuan
2018 (Portland) Annual Meeting

Educational Session
Novel Adaptive Designs for Phase I and II Clinical Trials

Session Details

Paola Berchialla
2018 (Portland) Annual Meeting

Contributed Session
Objective inference to adjust for baseline covariates in the analysis of randomized controlled trials for increasing efficiency

Session Details

Daniel Benjamin
2018 (Portland) Annual Meeting

Contributed Session
On the Accuracy of Oncology Experts’ Predictions about Safety in Randomized Cancer Trials

Session Details

Pamela Tenaerts
2018 (Portland) Annual Meeting

Contributed Session
One decade of impact. One vision ahead. Optimizing the power of public-private partnership: Lessons learned from the Clinical Trials Transformation Initiative

Session Details

Steven Edland
2018 (Portland) Annual Meeting

Contributed Session
Optimal Composite Endpoints for Clinical Trials of Chronic Progressive Disease

Session Details

J Athene Lane
2018 (Portland) Annual Meeting

Contributed Session
Optimising recruitment in clinical trials in surgery: how do surgical trainees working together achieve success?

Session Details

Sian Cousins
2018 (Portland) Annual Meeting

Contributed Session
Optimising the design of placebo-controlled RCTs of invasive procedures: An analysis of published RCTs

Session Details

Jay Siegel
2018 (Portland) Annual Meeting

Contributed Session
Optimizing Phase II Clinical Trials

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Optimizing the selection of mobile devices for data capture in clinical trials: Recommendations from the Clinical Trials Transformation Initiative

Session Details

Alice Biggane
2018 (Portland) Annual Meeting

Contributed Session
Participant Input in Core Outcome Set Development: Qualitative Study

Session Details

Caroline Hurley
2018 (Portland) Annual Meeting

Contributed Session
Perceived barriers and facilitators to Risk Based Monitoring in academic- led clinical trials – a mixed methods study

Session Details

Graham Wheeler
2018 (Portland) Annual Meeting

Contributed Session
PHASE I TRIALS OF IMMUNOTHERAPIES AND MOLECULARLY TARGETED AGENTS: WHAT DESIGNS ARE USED, AND HOW WELL ARE THEY REPORTED?

Session Details

Jose Jimenez
2018 (Portland) Annual Meeting

Contributed Session
Phase I/II Bayesian adaptive design with drug combinations and time-to-event data

Session Details

Jonathan Cook
2018 (Portland) Annual Meeting

Session Proposal
Placebo and sham controlled trials in surgery and in other invasive procedures: lessons, ethics and design issues

Session Details

RANI JAYSWAL
2018 (Portland) Annual Meeting

Contributed Session
Practical Methods for Utilization of Biomarkers to Assess Cancer Prognosis

Session Details

Scott Evans
2018 (Portland) Annual Meeting

Session Proposal
Pragmatic Benefit:risk Assessment in Clinical Trials: A New Paradigm Using Pairwise Comparison of Patients

Session Details

Paula Darby Lipman
2018 (Portland) Annual Meeting

Contributed Session
Pragmatic trial management: Exploring evidence for trial planning milestones

Session Details

Kirsty Loudon
2018 (Portland) Annual Meeting

Educational Session
Precisely how can this tool help investigators design trials to achieve practical answers to “real world” questions?

Session Details

Sonia Davis Thomas
2018 (Portland) Annual Meeting

Contributed Session
Predictive modeling of outcomes in a clinical trial with missing baseline data

Session Details

Heidi Gardner
2018 (Portland) Annual Meeting

Contributed Session
Presenting user-tested evidence based tools to support development of trial recruitment strategies

Session Details

on behalf of Bluebelle Study Group
2018 (Portland) Annual Meeting

Contributed Session
PSYCHOMETRIC AND INITIAL CLINICAL VALIDATION OF THE BLUEBELLE WOUND HEALING QUESTIONNAIRE (WHQ): A NEW OUTCOME MEASURE FOR POST-DISCHARGE ASSESSMENT OF WOUNDS FOR SURGICAL SITE INFECTION

Session Details

Elizabeth Wright
2018 (Portland) Annual Meeting

Contributed Session
Randomized Clinical Trial Abstracts Submitted to Major Medical Meetings: Do They Include Trial Registration Numbers and Conform to Consort Guidelines?

Session Details

Mackenzie Dome
2018 (Portland) Annual Meeting

Contributed Session
Reach Out: Randomized Clinical Trial of Emergency Department-Initiated Hypertension Behavioral Intervention Connecting Multiple Health Systems

Session Details

Yong Zang
2018 (Portland) Annual Meeting

Session Proposal
Recent Developments in Umbrella, Basket and Platform Trial Designs

Session Details

Karen Bracken
2018 (Portland) Annual Meeting

Contributed Session
Recruiting men aged 50-74 years to a large diabetes prevention trial: the effectiveness of traditional vs online promotional strategies

Session Details

Jamie Soames
2018 (Portland) Annual Meeting

Contributed Session
Reducing unnecessary antibiotic prescribing in primary care: a point-of-care electronic intervention using electronic healthcare records (REDUCE Trial)

Session Details

Shing Lee
2018 (Portland) Annual Meeting

Session Proposal
Reproducible Clinical Trials

Session Details

Melanie Bell
2018 (Portland) Annual Meeting

Contributed Session
Responder analysis with missing data: comparison of two imputation techniques in the context of randomized controlled trials

Session Details

Clare Relton
2018 (Portland) Annual Meeting

Contributed Session
RETHINKING THE ARCHITECTURE OF PRAGMATIC TRIALS

Session Details

Amber Randall
2018 (Portland) Annual Meeting

Contributed Session
Risk-based Validation in Clinical Trial Reporting: Focus on What Matters Most

Session Details

Simon Day (tentative)
2018 (Portland) Annual Meeting

Session Proposal
Role of Data Monitoring Committees in Complicated Trials

Session Details

David Collister
2018 (Portland) Annual Meeting

Contributed Session
Run-in periods in randomized controlled trials of chronic diseases: a meta-epidemiologic study

Session Details

Wayne Feng
2018 (Portland) Annual Meeting

Contributed Session
Safety and tolerability of transcranial direct current stimulation to stroke patients - A phase I current escalation study

Session Details

Wei Wang
2018 (Portland) Annual Meeting

Contributed Session
Safety Assessment Committee Joins with Data Monitoring Committee - Safety Is the New Efficacy

Session Details

Maria Ciarleglio
2018 (Portland) Annual Meeting

Contributed Session
Sample Size Estimation Using a Hybrid Classical and Bayesian Procedure

Session Details

DANILA AZZOLINA
2018 (Portland) Annual Meeting

Contributed Session
Sample size issues for non-inferiority clinical trials with multiple primary endpoints

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Selecting Technology Derived Novel Endpoints for Development and Inclusion in Clinical Trials

Session Details

Ying Liu
2018 (Portland) Annual Meeting

Contributed Session
SEQUENTIAL MULTIPLE ASSIGNMENT RANDOMIZED TRIALS FOR COMPARING PERSONALIZED ANTIMICROBIAL STRATEGIES (SMART COMPASS)

Session Details

Sarah Finlayson
2018 (Portland) Annual Meeting

Contributed Session
Should we plan for the unplanned? Managing undesirable but unavoidable protocol amendments in clinical trials.

Session Details

Kaitlyn Antonelli
2018 (Portland) Annual Meeting

Contributed Session
Site Activation Processes Predictive of Enrollment Success in a Pragmatic Precision Medicine Study

Session Details

Karen Innes
2018 (Portland) Annual Meeting

Contributed Session
Site Initiation Training – What can be learned from evaluating this process from multicentre trials?

Session Details

Hyunsook Chin
2018 (Portland) Annual Meeting

Contributed Session
Site Investigator vs. Sponsor SAE Causality: Are they different?

Session Details

Shaun Treweek
2018 (Portland) Annual Meeting

Contributed Session
Sixty-eight studies and (nearly) nothin’ on: the poor state of the recruitment intervention methodology literature and what to do about it

Session Details

Marta Bofill Roig
2018 (Portland) Annual Meeting

Contributed Session
Sizing clinical trials with composite binary endpoints

Session Details

Riaz Qureshi
2018 (Portland) Annual Meeting

Contributed Session
Standardized Reporting of Randomized Clinical Trials for Systematic Reviews: Systematic Review Data Repository

Session Details

Rebecca Paulus
2018 (Portland) Annual Meeting

Educational Session
Statistical Graphs in SAS Using Graphics Template Language (GTL)

Session Details

Abigail Baldridge
2018 (Portland) Annual Meeting

Contributed Session
StatTag for Connecting R, SAS, and Stata to Word: A Practical Approach to Reproducibility

Session Details

Abigail Baldridge
2018 (Portland) Annual Meeting

Educational Session
StatTag for Connecting R, SAS, and Stata to Word: A Practical Approach to Reproducibility

Session Details

Heidi Gardner
2018 (Portland) Annual Meeting

Contributed Session
Strategies to improve participant recruitment to randomised controlled trials: A systematic review of non-randomised evaluations

Session Details

Adel Gomaa Ibrahim El Feky
2018 (Portland) Annual Meeting

Contributed Session
Strategies to improve participant retention to randomized controlled trials: what do non-randomized evaluations of retention strategies have to tell us?

Session Details

Tsedenia Bezabeh
2018 (Portland) Annual Meeting

Contributed Session
STREAMLINING THE PROTOCOL OVERSIGHT PROGRAM FOR MAXIMUM EFFICIENCY IN THE DIABETES PREVENTION PROGRAM OUTCOMES STUDY (DPPOS)

Session Details

Kimberley Goldsmith
2018 (Portland) Annual Meeting

Educational Session
Studying Treatment Mechanisms – A Whistle Stop Tour of Simple Mediation Analysis

Session Details

Eileen Stock
2018 (Portland) Annual Meeting

Contributed Session
Surveillance of Serious Adverse Events in a Multisite Clinical Trial utilizing VA Healthcare Administrative Data

Session Details

Anna Moseley
2018 (Portland) Annual Meeting

Contributed Session
SURVIVAL BY HISPANIC ETHNICITY AMONG CANCER PATIENTS PARTICIPATING IN SWOG CLINICAL TRIALS

Session Details

Jade Fiotto
2018 (Portland) Annual Meeting

Contributed Session
Telephonic Informed Consent for Point of Care (POC) Clinical Trials

Session Details

Letitia Perdue
2018 (Portland) Annual Meeting

Contributed Session
The Central IRB Experience in a Minimal Risk Observational Study

Session Details

William Wood
2018 (Portland) Annual Meeting

Contributed Session
THE CHALLENGES AND OPPORTUNITIES OF MOBILE TECHNOLOGY: A QUALITATIVE EXAMINATION OF INVESTIGATORS’ EXPERIENCES AND RECOMMENDATIONS

Session Details

Jonathan Gibb
2018 (Portland) Annual Meeting

Contributed Session
The Data Extract Verify File – an open source and cross platform XML file to verify data extracts

Session Details

Mary Putt
2018 (Portland) Annual Meeting

Contributed Session
The Habit Formation Trial to Evaluate Behavioral Economic Interventions to Reduce the Risk of Cardiovascular Disease: Lessons Learned

Session Details

Tianchen Qian
2018 (Portland) Annual Meeting

Session Proposal
The Micro-Randomized Trial Design for developing adaptive mobile health interventions

Session Details

Mitra Lewis
2018 (Portland) Annual Meeting

Contributed Session
The National Drug Abuse Treatment Clinical Trials Network (NDAT CTN) Strategic Planning Group on Retention: Lessons Learned and Best Practices

Session Details

Nicholas Seedorff
2018 (Portland) Annual Meeting

Contributed Session
The National Institute of Neurology Disorders and Stroke Clinical Trials Methodology Course: Outcomes of Trainees after 3 Years

Session Details

Yuko Palesch
2018 (Portland) Annual Meeting

Session Proposal
The Role of Central IRB vs DSMB in the Decision Making Process for Premature Termination or Enrollment Suspension of a Multicenter Trial

Session Details

Jessica Kasza
2018 (Portland) Annual Meeting

Contributed Session
The standard error of the treatment effect in stepped wedge trials when the within-cluster correlation structure is misspecified

Session Details

Andrea Viecelli
2018 (Portland) Annual Meeting

Contributed Session
The Standardized Outcomes in Nephrology – Hemodialysis (SONG-HD) Initiative: establishing a core outcome set for trials in patients on hemodialysis

Session Details

David Kerr
2018 (Portland) Annual Meeting

Contributed Session
The Ugly Truths of Today’s DMCs – and What the SDAC Can Do to Help

Session Details

Nicholas Fergusson
2018 (Portland) Annual Meeting

Contributed Session
The win ratio approach in kidney transplant trials

Session Details

Ales Kotalik
2018 (Portland) Annual Meeting

Contributed Session
The win ratio approach to the analysis of a composite outcome in the Multiple Risk Factor Intervention Trial

Session Details

Brian Traver
2018 (Portland) Annual Meeting

Contributed Session
Time-Course Graphics for Individual Subjects In DMC Reports

Session Details

David Kerr
2018 (Portland) Annual Meeting

Educational Session
Training the Next Generation of DMC Members and the Teams that Support Them

Session Details

Eve Jelstrom
2018 (Portland) Annual Meeting

Contributed Session
Translating Assessments in Clinical Trials Conducted in the US

Session Details

Claire Cochran
2018 (Portland) Annual Meeting

Contributed Session
Traumatic Decisions; Research Recruitment and Randomisation in an Acute Emergency Setting

Session Details

Roberta Scherer
2018 (Portland) Annual Meeting

Contributed Session
Treatment adherence in the Tinnitus Retraining Therapy Trial

Session Details

Lucy Beasant
2018 (Portland) Annual Meeting

Contributed Session
Treatment preference in pediatric randomised clinical trials: systematic review and qualitative synthesis

Session Details

Navneet Hakhu
2018 (Portland) Annual Meeting

Contributed Session
TWO FACTORS IMPACTING FORMULATION OF DATA MONITORING COMMITTEE RECOMMENDATIONS FOR ADAPTIVE DESIGN CLINICAL TRIALS

Session Details

Michael J. Grayling
2018 (Portland) Annual Meeting

Educational Session
Understanding adaptive designs through single-arm trials

Session Details

Katherine Fairhurst
2018 (Portland) Annual Meeting

Contributed Session
Understanding progression from an internal pilot to a main trial: exploring views and perceptions of key stakeholders.

Session Details

J athene Lane
2018 (Portland) Annual Meeting

Contributed Session
Understanding strategies and practices that influence retention in clinical trials through an interview study of trial staff in five multi-centre trials

Session Details

Lesley Curtis
2018 (Portland) Annual Meeting

Contributed Session
Understanding the Clinical Trial Enterprise’s Newest Trend: Incorporating Real-World Evidence into Randomized Clinical Trials

Session Details

Chin-Fu Hsiao
2018 (Portland) Annual Meeting

Contributed Session
Use of A Bayesian Approach to Incorporate Toxicity Consideration Into The Two Stage Design of Phase II Clinical Trials

Session Details

Brian Perry
2018 (Portland) Annual Meeting

Contributed Session
Use of Qualitative Data Analysis Software to Facilitate a Systematic Literature Review

Session Details

Patricia Morris
2018 (Portland) Annual Meeting

Contributed Session
Using a Professional Tracing Service to Locate Participants 6 Years After Study Close-out

Session Details

Jennifer Goldsack
2018 (Portland) Annual Meeting

Contributed Session
Using a single, central IRB for a nationwide pragmatic clinical trial using claims data

Session Details

Kathryn Jackson
2018 (Portland) Annual Meeting

Contributed Session
Using Composite Surrogate Baseline Variables in a Modified Covariate-Constrained Randomization Algorithm

Session Details

Pablo Serrano
2018 (Portland) Annual Meeting

Contributed Session
USING ELECTRONIC DATABASES TO INCREASE ACCRUAL TO GASTROINTESTINAL CANCER CLINICAL TRIALS

Session Details

Lin Wang
2018 (Portland) Annual Meeting

Contributed Session
Using FDA website and ClinicalTrials.gov to identify trials for network meta-analysis: A case study on first-line medications for glaucoma

Session Details

Ian Wadsworth
2018 (Portland) Annual Meeting

Contributed Session
Using model-based approaches for determining optimal dosing rules in children

Session Details

Ron Marks
2018 (Portland) Annual Meeting

Contributed Session
Using Phase 2 Clinical Trial Design to Enhance the Phase 3 Process

Session Details

Kellee Miller
2018 (Portland) Annual Meeting

Contributed Session
Using Qualitative Data to Develop and Refine Interventions

Session Details

Shaun Treweek
2018 (Portland) Annual Meeting

Educational Session
Using Studies Within a Trial (SWATs) to increase the evidence base for trial recruitment and retention decision-making

Session Details

Marcus Johnson
2018 (Portland) Annual Meeting

Contributed Session
Utilization of a Paired Comparison Analysis Framework to Inform and Prioritize Decision-Making in a Highly Matrixed Clinical Research Program

Session Details

Dagmar Salazar
2018 (Portland) Annual Meeting

Contributed Session
Utilizing a Robust and Comprehensive Locator Form as a Retention Tool in Clinical Trials

Session Details

Daniel Goldenholz
2018 (Portland) Annual Meeting

Contributed Session
Variability adjusted time to event (VATE) method for analysis of randomized clinical trials in epilepsy and other episodic diseases

Session Details

Shun Fu Lee
2018 (Portland) Annual Meeting

Contributed Session
Variations in Design of the Stepped Wedge Cluster Randomized Trial: illustration of statistical concepts using the Patient-Centered Care Transitions in Heart Failure (PACT-HF) Trial

Session Details

Alan Stevenson
2018 (Portland) Annual Meeting

Contributed Session
Video Adjudication in Clinical Trials: Enabling Distribution of Expertise and Accurate Scoring

Session Details

Catherine Meyers
2018 (Portland) Annual Meeting

Session Proposal
What Are We Learning from Pragmatic Clinical Trials? Design, Implementation and Analytic Strategies

Session Details

Isoken Odia
2018 (Portland) Annual Meeting

Contributed Session
WHAT IS THE EFFECT OF TREATMENT CROSSOVER ON AN INTENTION TO TREAT ANALYSIS IN A NON-INFERIORITY TRIAL?

Session Details

merrick.zwarenstein@ices.on.ca
2018 (Portland) Annual Meeting

Session Proposal
When pragmatism and reality collide: use of the PRECIS 1 and 2 tools in PCORI funded trials

Session Details

Kristen Wroblewski
2018 (Portland) Annual Meeting

Contributed Session
Why Not Buckley-James? A Simulation Study

Session Details

J. Michael Gaziano
2017 (Liverpool) Annual Meeting

Founders Lecture
The Million Veteran Program: A Modern Mega-Cohort within a Healthcare systemUsing Big Health Data to Improve Health Care

Jerry Wolinsky
2017 (Liverpool) Annual Meeting

Trial of the Year Award
ORATORIO

James J. Dignam
2017 (Liverpool) Annual Meeting

Award Presentation
Thomas C. Chalmers Scholarship and Sylvan Green Awards

Susan S. Ellenberg
2017 (Liverpool) Annual Meeting

Curtis Meinert Lecture
Clinical Trials in the Twenty-First Century: Ongoing Challenges and Emerging Issues

Will Meurer & Jon Nichols
2017 (Liverpool) Annual Meeting

Special Presentation
Opening Remarks, Program Scientific Committee Co-Chairs

Susan Halabi
2017 (Liverpool) Annual Meeting

Fellows Presentation
Presentation of the Class of 2017 Fellows

Siobhan Bourke
2017 (Liverpool) Annual Meeting

Contributed Session
Rituximab for the treatment of neuromyelitis optica: an application of individual patient data meta-analysis in a rare disease.

Session Details

Clare Clement
2017 (Liverpool) Annual Meeting

Contributed Session
"To have and to hold, from this day forward": Understanding current practice regarding retention of trial particpants

Session Details

Clare Clement
2017 (Liverpool) Annual Meeting

Contributed Session
‘Enquiry into how Qualitative Methods Influence Trials and their Yields’ (EQUITY): Exploring registered trials that include a reported qualitative component

Session Details

Loretta Davies
2017 (Liverpool) Annual Meeting

Contributed Session
“I struggle with equipoise”: a qualitative study exploring clinicians’ views of a randomised controlled trial (ACL SNNAP) prior to trial conduct

Session Details

Andrew Embleton
2017 (Liverpool) Annual Meeting

Contributed Session
“If a tree falls in a forest…”: Abstract view statistics as a measure of research impact

Session Details

Alex Nicolson
2017 (Liverpool) Annual Meeting

Contributed Session
“More than the Emperor’s new clothes”: Enhancing meaningful Patient and Public Involvement in Trial Oversight Committees through qualitative research with eight clinical trials facing challenges

Session Details

Mary Rauchenberger
2017 (Liverpool) Annual Meeting

Contributed Session
“Will you walk a little faster?” - Joining the database development dance

Session Details

Laura Pankhurst
2017 (Liverpool) Annual Meeting

Contributed Session
40 is the magic number

Session Details

Alexina Mason
2017 (Liverpool) Annual Meeting

Contributed Session
A Bayesian framework to address missing not at random data in longitudinal studies with multiple types of missingness

Session Details

Moreno Ursino
2017 (Liverpool) Annual Meeting

Contributed Session
A Bayesian weighted quasi-likelihood design for Phase I/II clinical trial with repeated dose administration in preterm newborns.

Session Details

Alba Realpe
2017 (Liverpool) Annual Meeting

Contributed Session
A case study method to support and promote recruitment at a multi-centre RCT comparing surgical versus non-surgical treatments

Session Details

Joy Esterlitz
2017 (Liverpool) Annual Meeting

Contributed Session
A Common Data Language for Clinical Research Studies: Five (5) New Disease Recommendations from the National Institute of Neurological Disorders and Stroke, National Institutes of Health Common Data Elements Project

Session Details

Brennan Kahan
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of adjudication approaches for clinical trials

Session Details

Lesley-Anne Carter
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of baseline as response and missing indicator methods for missing baseline data in a mixed design cluster randomised control trial

Session Details

Jemma Hudson
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of methods to handle missing data in the analysis of an area under the curve outcome

Session Details

Ines Rombach
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of statistical approaches for analysing missing longitudinal patient reported outcome data in randomised controlled trials

Session Details

Peter Godolphin
2017 (Liverpool) Annual Meeting

Contributed Session
A comparison of stroke diagnosis at trial entry by local clinicians versus independent adjudicators: secondary analysis and simulation

Session Details

Marcus Johnson
2017 (Liverpool) Annual Meeting

Contributed Session
A Cross-Cutting Approach to Clinical Trial Success: The US Department of Veterans Affairs’ Network of Dedicated Enrollment Sites (NODES) Model

Session Details

Suzanne Freeman
2017 (Liverpool) Annual Meeting

Contributed Session
A framework for identifying treatment-covariate interactions in individual participant data network meta-analysis

Session Details

Gordon Fernie
2017 (Liverpool) Annual Meeting

Contributed Session
A good use of time and money? A study of how trial data collection effort is distributed across different categories of data.

Session Details

Toby Prevost
2017 (Liverpool) Annual Meeting

Contributed Session
A journey from statistical consultation to funded adaptive trial

Session Details

Iryna Schlackow
2017 (Liverpool) Annual Meeting

Contributed Session
A lifetime disease model based on an RCT: development, validation and applications

Session Details

Pankaj Mistry
2017 (Liverpool) Annual Meeting

Contributed Session
A literature review of the use of Adaptive Design methods in Oncology trials.

Session Details

Derk Arts
2017 (Liverpool) Annual Meeting

Contributed Session
A look at the future of data standardization and sharing in clinical research.

Session Details

Graham Wheeler
2017 (Liverpool) Annual Meeting

Contributed Session
A model-free Bayesian adaptive design for combination therapy dose-finding trials with censored time-to-toxicity data

Session Details

Claire Dyer
2017 (Liverpool) Annual Meeting

Contributed Session
A Multi-Centred Study Validating a Bleeding Assessment Tool (BAT) Developed by the Biomedical Excellence for Safer Transfusion (BEST) Collaborative For Use in Adult Patients with Haematological Malignancy

Session Details

Matteo Quartagno
2017 (Liverpool) Annual Meeting

Contributed Session
A new design for trials for finding optimal treatment duration

Session Details

Emma Wang
2017 (Liverpool) Annual Meeting

Contributed Session
A novel approach to analysis of clinical trials for rare cancers assuming symmetry

Session Details

Hannah Buckley
2017 (Liverpool) Annual Meeting

Contributed Session
A Phase II randomised controlled trial with biomarkers in soft tissue sarcoma: application of a biomarker stratified design

Session Details

Elizabeth Randell
2017 (Liverpool) Annual Meeting

Contributed Session
A pilot randomised controlled trial of community led anti-psychotic drug reduction for adults with learning disabilities: ANDREA-LD

Session Details

Meng Liu
2017 (Liverpool) Annual Meeting

Contributed Session
A predictive probability interim design for phase II clinical trials with continuous endpoints

Session Details

Toshimitsu Hamasaki
2017 (Liverpool) Annual Meeting

Contributed Session
A Program for Training the Next Generation of Biostatisticians in Japan: Developing On-the-Job Training at NCVC

Session Details

Caitlin O'Hara
2017 (Liverpool) Annual Meeting

Contributed Session
A qualitative feasibility study to inform fluids in shock (FiSh) - a pilot randomised controlled trial of fluid bolus therapy in septic shock

Session Details

Caroline Rick
2017 (Liverpool) Annual Meeting

Contributed Session
A reflection on the management of a trial of speech and language therapy.

Session Details

James Howlett
2017 (Liverpool) Annual Meeting

Contributed Session
A Response-Adaptive Trial to Determine the Optimal IL-2 Dose-Frequency to Achieve Multiple Target Increases on Regulatory T Cells in Type 1 Diabetes: DILfrequency study

Session Details

Isabelle Smith
2017 (Liverpool) Annual Meeting

Contributed Session
A review of design and analysis methods for pressure ulcer research

Session Details

Daniel Greenwood
2017 (Liverpool) Annual Meeting

Contributed Session
A review of dose escalation methods in first-in-human small molecule oncology clinical trials

Session Details

Dewen Yang
2017 (Liverpool) Annual Meeting

Contributed Session
A Review of the Essentials and Pitfalls of the Lugano Classification in Malignant Lymphoma Trials

Session Details

Jelena Savovic
2017 (Liverpool) Annual Meeting

Contributed Session
A revised tool for assessing risk of bias in randomized trials (RoB 2.0)

Session Details

Andrew Forbes
2017 (Liverpool) Annual Meeting

Contributed Session
A simple relationship between power and expected confidence interval width

Session Details

Diane Whitham
2017 (Liverpool) Annual Meeting

Contributed Session
A study aimed at improving the conduct and efficiency of trials by developing a standardised set of site performance metrics and a systematic approach to reporting

Session Details

Sophie Betteridge
2017 (Liverpool) Annual Meeting

Contributed Session
A system for real-time integration of laboratory data into trials of targeted therapy with applications to Acute Myeloid Leukaemia

Session Details

Rebecca Barnes
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic mapping review of methods used for the evaluation of implementation fidelity in primary care trials

Session Details

Sena Jawad
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review identifying neonatal core data elements for clinical trials, and assessment of data completeness of identified data elements using the National Neonatal Research Database (NNRD)

Session Details

Richéal Burns
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review of analytical methods applied for discarded organs in kidney and liver transplantation research

Session Details

Heather Catt
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review of core outcomes for Crohn's Disease in adults

Session Details

Katie Gillies
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review of measures of informed consent for randomised controlled trials.

Session Details

Katie Sworn
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review of the different approaches to intervention development

Session Details

Jane Dennis
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic review to inform a trial of comprehensive pain management for patients with chronic pain after total knee replacement: the STAR experience

Session Details

Jamie Kirkham
2017 (Liverpool) Annual Meeting

Contributed Session
A systematic search of ClinicalTrials.gov to assess the uptake of core outcome sets

Session Details

Allan Walker
2017 (Liverpool) Annual Meeting

Contributed Session
A targeted approach to drug-supply in RCTs limits wastage and can reduce costs. The experience of the MS-Smart trial

Session Details

Heather Bagley
2017 (Liverpool) Annual Meeting

Contributed Session
A Toolkit for Patient and Public Involvement in a Clinical Trials Unit – An Update & Next Steps

Session Details

Michelle DeVeaux
2017 (Liverpool) Annual Meeting

Contributed Session
A Two-Stage, Phase II Clinical Trial Design with Nested Criteria for Early Stopping and Efficacy

Session Details

Chao Huang
2017 (Liverpool) Annual Meeting

Contributed Session
A validation and calibration process on self-reported tobacco with participants’ cotinine levels in Building Blocks

Session Details

Nigel Stallard
2017 (Liverpool) Annual Meeting

Contributed Session
A Value of Information approach to optimal design of confirmatory clinical trials

Session Details

Joana Vasconcelos
2017 (Liverpool) Annual Meeting

Contributed Session
A way to assess the impact of an omitted study on the overall meta-analysis estimate

Session Details

Sheau-Chiann Chen
2017 (Liverpool) Annual Meeting

Contributed Session
A web application for optimal selection of adaptive designs in phase I oncology clinical trials

Session Details

Kevin Wilson
2017 (Liverpool) Annual Meeting

Contributed Session
A WEB-BASED SYSTEM FOR THE MANAGEMENT AND STORAGE OF METADATA FOR MULTI-CENTER CLINICAL TRIALS

Session Details

Jane Aziz
2017 (Liverpool) Annual Meeting

Contributed Session
Access and security considerations of using ePROMS to collect follow-up data for clinical trials

Session Details

Rema Raman, PhD
2017 (Liverpool) Annual Meeting

Session Proposal
Acquisition and sharing of data in Alzheimer’s Disease Research

Session Details

Marcus Jepson
2017 (Liverpool) Annual Meeting

Contributed Session
Adapting the QuinteT Recruitment Intervention (QRI) to optimise recruitment in an ongoing randomised controlled trial

Session Details

Rachel Blundred
2017 (Liverpool) Annual Meeting

Contributed Session
Adapting trial design for challenging populations: How the Rational MCC trial was designed to account for a rare, aggressive cancer in an elderly and diverse population

Session Details

Christopher Jennison
2017 (Liverpool) Annual Meeting

Educational Session
Adaptive Designs Showcase and Panel Discussion

Session Details

Christopher Jennison
2017 (Liverpool) Annual Meeting

Session Proposal
Adaptive Designs Showcase and Panel Discussion

Session Details

Deepak Parashar
2017 (Liverpool) Annual Meeting

Contributed Session
Adaptive enrichment design for randomised clinical trials with predictive biomarkers

Session Details

Ben Saville, Ph.D.
2017 (Liverpool) Annual Meeting

Educational Session
Adaptive Multi-arm Platform Trials

Session Details

Brett Hanscom
2017 (Liverpool) Annual Meeting

Contributed Session
Adaptive Non-Inferiority Margins under Obervable Non-Constancy

Session Details

Yu Lan
2017 (Liverpool) Annual Meeting

Contributed Session
Adaptive Prediction of Event Times in Clinical Trials

Session Details

Laura Flight
2017 (Liverpool) Annual Meeting

Session Proposal
Adaptive Study Designs and Health Economic Evaluations

Session Details

Tom Morris
2017 (Liverpool) Annual Meeting

Contributed Session
Adjusting trial analyses for continuous stratification variables

Session Details

Kirsty Rhodes
2017 (Liverpool) Annual Meeting

Contributed Session
Adjusting trial results for biases in meta-analysis: combining generic evidence on bias with detailed trial assessment

Session Details

Rebecca Mercieca-Bebber
2017 (Liverpool) Annual Meeting

Contributed Session
Administering patient-reported outcome questionnaires in Australian cancer trials: the roles, experiences, training received and needs of site coordinators

Session Details

Adwoa Hughes-Morley
2017 (Liverpool) Annual Meeting

Educational Session
Advancing trial efficiency through embedded recruitment and retention trials

Session Details

Vichithranie MADURASINGHE
2017 (Liverpool) Annual Meeting

Contributed Session
Adverse outcomes in non-drug intervention trials: what and how these are recorded

Session Details

Heather Bagley
2017 (Liverpool) Annual Meeting

Contributed Session
Agreeing outcomes that matter to patients – what are the challenges?

Session Details

Cody Chiuzan
2017 (Liverpool) Annual Meeting

Session Proposal
Alternative Endpoints and Dose Selection Methods in Early-Phase Cancer Trials

Session Details

James Dignam
2017 (Liverpool) Annual Meeting

Session Proposal
Alternative metrics and inference tools in clinical trials with time-to-event data: Beyond the hazard ratio and log-rank test.

Session Details

Vicky Tsipouri
2017 (Liverpool) Annual Meeting

Contributed Session
Ambulatory oxygen in fibrotic lung disease (AmbOx): study protocol for a randomised controlled trial.

Session Details

Maria Altzerinakou
2017 (Liverpool) Annual Meeting

Contributed Session
An adaptive design for the identification of the optimal dose using joint modelling of efficacy and toxicity in phase I/II clinical trials of molecularly targeted agents

Session Details

Melina Dritsaki
2017 (Liverpool) Annual Meeting

Contributed Session
An annotated guideline to the use of a Health Economics Analysis Plan (HEAP) alongside randomised controlled trials.

Session Details

Bethan Copsey
2017 (Liverpool) Annual Meeting

Contributed Session
An assessment of the design and dissemination of Phase I clinical trials: where can we improve?

Session Details

Austin Horn
2017 (Liverpool) Annual Meeting

Contributed Session
An ethical analysis of the FIRST Trial: Addressing ethical challenges in pragmatic cluster randomized trials of policy interventions targeting healthcare providers

Session Details

Fan Li
2017 (Liverpool) Annual Meeting

Contributed Session
An evaluation of constrained randomization for the design and analysis of group-randomized trials with binary outcomes

Session Details

Emma Clark
2017 (Liverpool) Annual Meeting

Contributed Session
An evaluation of statistical methods for predicting timelines for reaching target number of events in clinical trials with time-to-event endpoints

Session Details

Nicola Mills
2017 (Liverpool) Annual Meeting

Contributed Session
An evaluation of the impact of QuinteT RCT recruitment training on the self-confidence and self-assessed recruitment practice of recruiters to surgical trials

Session Details

Joseph Rausch
2017 (Liverpool) Annual Meeting

Contributed Session
An Evaluation of Treatment Effect Estimators When Primary Outcome Data are Missing in Longitudinal Randomized Clinical Trials

Session Details

Leila Rooshenas
2017 (Liverpool) Annual Meeting

Contributed Session
An intervention to optimise recruitment in challenging RCTs: implementation of the 'Quintet Recruitment Intervention' across eight pilot/feasibility RCTs

Session Details

Rebecca Simpson
2017 (Liverpool) Annual Meeting

Contributed Session
AN INVESTIGATION OF THE FACTORS WHICH INFLUENCE CHILDREN WITH ASTHMA HAVING UNSCHEDULED MEDICAL CONTACTS AROUND THE START OF THE NEW SCHOOL YEAR IN ENGLAND AND WALES – A MIXED METHODS STUDY

Session Details

ENASS DURO
2017 (Liverpool) Annual Meeting

Contributed Session
An investigation of the methods used to design, analysis and quantify non-inferiority margins in four medical journals in a 12 month time period

Session Details

Andrew Brand
2017 (Liverpool) Annual Meeting

Contributed Session
An Online Tool for Exploring Recruitment Achievability for a Feasibility and Pilot Studies in the UK.

Session Details

Sara Khalid
2017 (Liverpool) Annual Meeting

Contributed Session
An Oxford Knee Score cut-off point to identify patients with chronic pain after knee replacement for a complex intervention trial

Session Details

Rebecca Evans
2017 (Liverpool) Annual Meeting

Contributed Session
Analysis challenges in Blood Stream Infection: Focus on outcomes study

Session Details

Ross Peterson
2017 (Liverpool) Annual Meeting

Contributed Session
Analysis of an ordinal endpoint for use in evaluating treatments for severe influenza requiring hospitalization

Session Details

Laurent Billot
2017 (Liverpool) Annual Meeting

Contributed Session
Analysis of the Head Position in Stroke Trial (HeadPoST): an international cluster randomised cross-over trial

Session Details

Athanasia Gravani
2017 (Liverpool) Annual Meeting

Contributed Session
ANALYSIS OF TRIAL-SPECIFIC TRAINING DURING THE SITE INITIATION PHASE: THE ATLAS STUDY

Session Details

Rebecca Playle
2017 (Liverpool) Annual Meeting

Contributed Session
Analysis strategies for two-level clustering in one arm of a randomised group therapy trial set in Cardiff Prison

Session Details

Susanna Dodd
2017 (Liverpool) Annual Meeting

Session Proposal
Application of causal analysis in clinical trials

Session Details

Mark Van Natta
2017 (Liverpool) Annual Meeting

Contributed Session
Application of Recent NEJM Recommendations for Supplementary Analyses of Positive or Failed Randomized Clinical Trials

Session Details

Wenle Zhao
2017 (Liverpool) Annual Meeting

Contributed Session
Architecture design of an automated study drug distribution coordination module integrated in a web-based clinical trial management system

Session Details

Yuan Huang
2017 (Liverpool) Annual Meeting

Contributed Session
ASCERTAINING STUDY PARTICIPANT SAFETY USING CENTRALIZED ELECTRONIC MEDICAL RECORDS IN A CLINICAL TRIAL SETTING --- LESSONS LEARNED FROM THE VETERANS AFFAIRS NEPHRON-D TRIAL

Session Details

Charlotte Murkin
2017 (Liverpool) Annual Meeting

Contributed Session
Assessing clinically relevant endpoints in a pragmatic trial: Development of a measure to identify relevant clinical symptoms.

Session Details

Elaine Toomey
2017 (Liverpool) Annual Meeting

Contributed Session
Assessing implementation fidelity in clinical trials of behaviour change interventions

Session Details

Karen Barnes
2017 (Liverpool) Annual Meeting

Contributed Session
Assessing the impact of a funder’s recommendation on consideration and uptake of core outcome sets in funding applications

Session Details

Peter Godolphin
2017 (Liverpool) Annual Meeting

Contributed Session
Assessing the impact of independent adjudication of serious adverse events on the safety results of the Efficacy of Nitric Oxide in Stroke (ENOS) Trial

Session Details

Sabine Landau
2017 (Liverpool) Annual Meeting

Contributed Session
Assessing treatment effect moderation in trials of psychological interventions: A case for individual participant data meta-analysis of pooled trials

Session Details

Nada Alsowaida
2017 (Liverpool) Annual Meeting

Contributed Session
Assessment of the reporting quality of RCTs conducted in Saudi Arabia: A systematic review

Session Details

Chris Rogers
2017 (Liverpool) Annual Meeting

Contributed Session
Audio-recording recruitment consultations – an exploratory study in two RCTs to investigate the impact on randomisation rates

Session Details

Elizabeth Hill
2017 (Liverpool) Annual Meeting

Contributed Session
Automated solution for importing lab test results from a laboratory information management system into an electronic data capture system

Session Details

Elizabeth Hill
2017 (Liverpool) Annual Meeting

Contributed Session
Automated solution for tracking electronic case report form completion

Session Details

Ting Wang
2017 (Liverpool) Annual Meeting

Contributed Session
Auxiliary-variable-enriched Biomarker Stratified Design

Session Details

Matthew Sydes, MRC CTU at UCL, London, UK
2017 (Liverpool) Annual Meeting

Session Proposal
Balancing on-site and central monitoring: where does new evidence leads us?

Session Details

Marina Zaki
2017 (Liverpool) Annual Meeting

Contributed Session
Barriers and Facilitators to Statistical Rigour in Clinical Trials - Emerging Themes from the Literature

Session Details

Adedayo Oke
2017 (Liverpool) Annual Meeting

Contributed Session
Barriers to recruitment from primary care into a trial in secondary care settings: experience from the feasibility study of IBIS-3 trial

Session Details

Shalini Santhakumaran
2017 (Liverpool) Annual Meeting

Contributed Session
Bayesian methods for informative missingness in longitudinal intensive care data

Session Details

Chris Newby
2017 (Liverpool) Annual Meeting

Contributed Session
Bayesian prediction of the Intra-cluster correlation for sample size calculation of cluster randomised trials

Session Details

Xinxue Liu
2017 (Liverpool) Annual Meeting

Contributed Session
Bayesian predictive probability design in single-arm cancer phase II trials: is it superior to Frequentist design?

Session Details

Sonia Davis
2017 (Liverpool) Annual Meeting

Contributed Session
Best Practices for Reporting Safety Data to Data Monitoring Committees

Session Details

Dikla Blumberg
2017 (Liverpool) Annual Meeting

Contributed Session
Best practices for study drug management and accountability throughout the study lifecycle in multi-site randomized controlled trials

Session Details

Natalie Blencowe
2017 (Liverpool) Annual Meeting

Contributed Session
Beyond blinding: a systematic review to explore performance bias in surgical RCTs

Session Details

Gita Thanarajasingam
2017 (Liverpool) Annual Meeting

Contributed Session
Beyond Maximum Grade: A Novel Longitudinal Toxicity over Time (ToxT) Adverse Event Analysis for Targeted Therapy Trials in Lymphoma

Session Details

Allan Wilson
2017 (Liverpool) Annual Meeting

Contributed Session
Big Data Analytics and the Elephant in the Room

Session Details

Sarah Kernaghan
2017 (Liverpool) Annual Meeting

Contributed Session
Biological sample collection: considerations and lessons learnt at ICR-CTSU

Session Details

David Raunig
2017 (Liverpool) Annual Meeting

Contributed Session
Biomarker Validation as a Clinical Trial Endpoint: What works and what doesn’t

Session Details

Miranta Antoniou
2017 (Liverpool) Annual Meeting

Contributed Session
Biomarker-guided clinical trial designs: Sample size calculations with survival endpoints

Session Details

Ella Zadorozny
2017 (Liverpool) Annual Meeting

Contributed Session
Biospecimen Management System that Streamlines Processes and Reduces Inherent Challenges

Session Details

Michael Grayling
2017 (Liverpool) Annual Meeting

Contributed Session
Blinded and unblinded sample size re-estimation procedures for stepped wedge cluster randomised trials

Session Details

Pascal Probst
2017 (Liverpool) Annual Meeting

Contributed Session
Blinding in randomized controlled trials in general and abdominal surgery: a systematic review and empirical study

Session Details

Paul McGarry
2017 (Liverpool) Annual Meeting

Contributed Session
Breaking up is hard to do: Letting go of paper case report forms (CRFs) and the challenges of adapting data management processes to remote data entry (RDE)

Session Details

Julia Wade
2017 (Liverpool) Annual Meeting

Contributed Session
Bridging the gap between knowledge and practice: methods developed within the ProtecT trial to optimise implementation of findings in clinical policy and practice.

Session Details

Katie Flaherty
2017 (Liverpool) Annual Meeting

Contributed Session
Brief consent forms enable rapid enrolment in acute clinical trials: Data from the on-going Tranexamic acid for hyperacute primary IntraCerebral Haemorrhage (TICH-2) study.

Session Details

Robbie Wilson
2017 (Liverpool) Annual Meeting

Contributed Session
Building a generic Drug Supply Management system for eCRF systems – challenges and experience gained

Session Details

Jonathan Gibb
2017 (Liverpool) Annual Meeting

Contributed Session
Building a new EDC in 2016

Session Details

Cushla Cooper
2017 (Liverpool) Annual Meeting

Contributed Session
Building a relationship with industry – an academic’s experience working with Zimmer Biomet.

Session Details

Ileana Baldi
2017 (Liverpool) Annual Meeting

Contributed Session
Building comprehensive searches through a Machine Learning approach for systematic reviews

Session Details

The RELEASE Collaboration
2017 (Liverpool) Annual Meeting

Contributed Session
Building on the past: systematic identification, data extraction and synthesis of pre-existing individual stroke patient datasets to inform the development and design of future clinical trials.

Session Details

Nils Ternès
2017 (Liverpool) Annual Meeting

Contributed Session
Calculating expected survival from high-dimensional Cox models with treatment-by-biomarker interactions in randomized clinical trials

Session Details

Jessica Kendall
2017 (Liverpool) Annual Meeting

Contributed Session
Calibrated Phase II Oncology Design in a Bayesian Setting

Session Details

Kirsteen Goodman
2017 (Liverpool) Annual Meeting

Contributed Session
Can behaviour change theory increase questionnaire response rates within trials?

Session Details

Ranjit Lall
2017 (Liverpool) Annual Meeting

Contributed Session
Can Complex Intervention clinical trials capture treatment effects using a single primary outcome?

Session Details

Peter McCulloch, Chair, IDEAL Collaboration
2017 (Liverpool) Annual Meeting

Session Proposal
CAN PROSPECTIVE COLLABORATIVE COHORT STUDIES EASE THE WAY TO RCTS OF COMPLEX INTERVENTIONS?

Session Details

Diane Whitham
2017 (Liverpool) Annual Meeting

Contributed Session
Can site recruitment be predicted? Results of a retrospective, blinded evaluation of a site selection questionnaire in five multicentre trials

Session Details

Seonaidh Cotton
2017 (Liverpool) Annual Meeting

Contributed Session
Can trial managers predict whether sites will recruit to target or not? Results from the Estimating Site Performance (ESP) study

Session Details

Carlo Lancia
2017 (Liverpool) Annual Meeting

Contributed Session
Causal inference with randomised clinical trials of chemotherapy: the importance of well-documented treatment side-effects

Session Details

Trisha Boekhoudt
2017 (Liverpool) Annual Meeting

Contributed Session
CENTRAL CHART REVIEW OF COMPLEX OUTCOMES

Session Details

Caitlyn Ellerbe
2017 (Liverpool) Annual Meeting

Session Proposal
Challenges and Potential Solutions to Translating a Research Idea into a Clinical Trial - Case Studies from the StrokeNet Disease Network

Session Details

Julie Croft
2017 (Liverpool) Annual Meeting

Contributed Session
Challenges faced during implementation of a surgical clinical trial

Session Details

Megan Wirth
2017 (Liverpool) Annual Meeting

Contributed Session
Challenges in Implementing and Managing Clinical Trials in Developing Countries: Lessons Learned by The National Cancer Institute’s (NCI) AIDS Malignancy Consortium (AMC)

Session Details

Laura Cavaliere
2017 (Liverpool) Annual Meeting

Contributed Session
Challenges in teaching clinical trials: the experience of teaching biostatistics in online post-graduate academic courses, target to industrial biometrician

Session Details

Helena Smartt
2017 (Liverpool) Annual Meeting

Contributed Session
Challenges in the analysis of a randomised controlled trial with retrospective consenting: the RAPIDO study

Session Details

Dominic Hague
2017 (Liverpool) Annual Meeting

Contributed Session
Changing platforms without stopping the train : A Data Management Perspective on the operational aspects of adaptive platform trials

Session Details

Anne Daykin
2017 (Liverpool) Annual Meeting

Contributed Session
Changing roles and relationships within trial oversight: An ethnographic study of eight clinical trials facing challenges

Session Details

Era Prakash
2017 (Liverpool) Annual Meeting

Session Proposal
Changing the Way We Recruit Patients for Clinical Trials

Session Details

Louise Roper
2017 (Liverpool) Annual Meeting

Contributed Session
CHILDREN AND YOUNG PEOPLE’S VIEWS ON RESEARCH WITHOUT PRIOR CONSENT IN LIFE THREATENING SITUATIONS: A QUALITATIVE STUDY

Session Details

Kim Harman
2017 (Liverpool) Annual Meeting

Contributed Session
Chinese Herbal Medicine (CHM) for Recurrent UTIs in Women, a feasibility trial.

Session Details

Tim Morris
2017 (Liverpool) Annual Meeting

Contributed Session
Choosing between cross-over and re-randomisation designs for conditions with multiple treatment episodes

Session Details

Barbara Hawkins
2017 (Liverpool) Annual Meeting

Contributed Session
Citation of Articles Published in Clinical Trials: Design Articles vs. Others

Session Details

Rhiannon Macefield
2017 (Liverpool) Annual Meeting

Contributed Session
Clinical and psychometric validation of a new outcome measure: methods to assess measurement properties in the absence of a 'gold' standard

Session Details

Ionut Bebu
2017 (Liverpool) Annual Meeting

Session Proposal
Clinical Studies with Long-term Follow-up: Experiences and Lessons Learned

Session Details

Claire Snowdon
2017 (Liverpool) Annual Meeting

Contributed Session
Clinical Trial Data and Tissue – Considerations for Responsible Sharing

Session Details

Gabriele Dreier
2017 (Liverpool) Annual Meeting

Contributed Session
Clinical Trial Units of Medical Scientific Societies to close Evidence Gaps

Session Details

Abhik Das
2017 (Liverpool) Annual Meeting

Contributed Session
Clinical trials in neonatology: Design and analyses issues

Session Details

Laura Pankhurst
2017 (Liverpool) Annual Meeting

Contributed Session
Clinical trials in organ donation and transplantation in the UK - benefits and challenges

Session Details

Joerg Hasford
2017 (Liverpool) Annual Meeting

Contributed Session
Clinical Trials: increasing value, reducing waste - the potential role of Ethics Committees

Session Details

Elizabeth Wright
2017 (Liverpool) Annual Meeting

Contributed Session
Cluster Randomized Clinical Trials: Can they be found in PubMed and clinical trial registries and do they adhere to CONSORT guidelines?

Session Details

Lucy Brading
2017 (Liverpool) Annual Meeting

Contributed Session
Collating the evidence base to facilitate patient and public involvement in core outcome set development – a qualitative meta-synthesis

Session Details

Lucy Culliford
2017 (Liverpool) Annual Meeting

Contributed Session
Collecting trial quality data about complications routinely: a study within a study to maximize efficiency

Session Details

Matthew Sydes, (1) MRC CTU at UCL, London, UK; (2) MRC London Hub for Trials Methodology Research, London, UK
2017 (Liverpool) Annual Meeting

Session Proposal
Communicating trial results to participants

Session Details

Lei Clifton
2017 (Liverpool) Annual Meeting

Contributed Session
Comparing different ways of calculating sample size for a randomised controlled trial using baseline and post-intervention measurements

Session Details

Caroline Rick
2017 (Liverpool) Annual Meeting

Contributed Session
Comparing the challenges of the management of trials of medical tests versus randomised controlled trials of health care interventions.

Session Details

James Griffin
2017 (Liverpool) Annual Meeting

Contributed Session
Comparison and impact of prospective and retrospective falls data completion methods in the PreFIT trial: Results of a randomised methodology study within a trial (SWAT)

Session Details

Lisa Woodhouse
2017 (Liverpool) Annual Meeting

Contributed Session
Comparison of global statistical analyses in patients with hyper-acute stroke: assessment of randomised trials of transdermal glyceryl trinitrate, a nitric oxide donor

Session Details

Giovanna Culeddu
2017 (Liverpool) Annual Meeting

Contributed Session
Comparison of regression methods for the cost effectiveness analysis of clinical trials with a small population size: the SYCAMORE and FolATED trials.

Session Details

Julia Edwards
2017 (Liverpool) Annual Meeting

Contributed Session
Concealing the randomised allocation in trials: experience from the Thermic trials

Session Details

Stanley Musgrave
2017 (Liverpool) Annual Meeting

Contributed Session
Concepts important to the design of an innovative risk register in general practice databases – developing methodology from ARRISA-UK

Session Details

Shah-Jalal Sarker
2017 (Liverpool) Annual Meeting

Contributed Session
Concurrent versus sequential addition of diethylstilbestrol with dexamethasone in the treatment of castration-resistant prostate cancer: An exploratory analysis

Session Details

David Robertson
2017 (Liverpool) Annual Meeting

Contributed Session
Conditionally unbiased estimation in two-stage adaptive trials with unknown variances

Session Details

Katie Griffin
2017 (Liverpool) Annual Meeting

Contributed Session
Conduct of a Precision Medicine Trial: Screening, Tissue Adequacy, Study Registration, and Reasons For Not Participating on Lung-MAP (Lung Cancer Master Protocol)

Session Details

Professor Amanda Farrin
2017 (Liverpool) Annual Meeting

Session Proposal
Conducting trials in adult populations with diminished capacity

Session Details

Peter Mulhall
2017 (Liverpool) Annual Meeting

Contributed Session
Conducting Trials with hard to recruit disabled populations: A systematic review of the methodological challenges reported in the literature.

Session Details

Julia Sanders
2017 (Liverpool) Annual Meeting

Contributed Session
Consent pathway options in trials of emergency interventions

Session Details

Lawrence Mbuagbaw
2017 (Liverpool) Annual Meeting

Contributed Session
Considerations in designing equity-relevant clinical trials

Session Details

Eve Jelstrom
2017 (Liverpool) Annual Meeting

Contributed Session
Considering Sex as a Biological Variable in Research Design, Data Analyses and Reporting

Session Details

Rebecca Mister
2017 (Liverpool) Annual Meeting

Contributed Session
Consolidated trial management: An example of a purpose built Clinical Trial Management System for an Academic Research Organisation

Session Details

Nicholas Magill
2017 (Liverpool) Annual Meeting

Contributed Session
Contamination in trials of complex interventions: measuring and accounting for it in the analysis of a trial

Session Details

Lisa Woodhouse
2017 (Liverpool) Annual Meeting

Contributed Session
Continue or Stop: the rationale for early closedown of a clinical trial as a result of stopping rules within the data monitoring committee charter

Session Details

Masha Kocherginsky
2017 (Liverpool) Annual Meeting

Contributed Session
Continuous Safety Monitoring in Large Phase I Cancer Clinical Trials with Multiple Expansion Cohorts

Session Details

Haolun Shi
2017 (Liverpool) Annual Meeting

Contributed Session
Control of type I error rates in Bayesian group sequential designs

Session Details

Joanna Thorn
2017 (Liverpool) Annual Meeting

Contributed Session
Core items for a standardised resource-use measure (ISRUM): expert Delphi consensus survey

Session Details

Amarnath Vijayarangan
2017 (Liverpool) Annual Meeting

Contributed Session
Cost Effective Interactive Live Clinical Data Monitoring Dashboards with Drill-Down

Session Details

Baptiste Leurent
2017 (Liverpool) Annual Meeting

Contributed Session
Cost-effectiveness analysis of clinical trials with missing data: using multiple imputation to address data missing not at random

Session Details

Ram Bajpai
2017 (Liverpool) Annual Meeting

Contributed Session
Could adaptive research designs be useful in designing an effective eHealth intervention? A methodological analysis

Session Details

Robin Bechhofer
2017 (Liverpool) Annual Meeting

Educational Session
Creating Effective Reports for Data Monitoring Committees (DMCs)

Session Details

Kent Koprowicz
2017 (Liverpool) Annual Meeting

Contributed Session
Current Trends in Data Monitoring Committees

Session Details

Shaun Treweek
2017 (Liverpool) Annual Meeting

Session Proposal
Data and Biospecimen Sharing: Enhancing Collaborative Science Globally

Session Details

Michelle Steven
2017 (Liverpool) Annual Meeting

Contributed Session
Data Management Lifecycle Evaluation

Session Details

Virginia Chiocchia
2017 (Liverpool) Annual Meeting

Contributed Session
Data Monitoring Committee overseeing multiple international randomised controlled trials

Session Details

Lynn A. Sleeper
2017 (Liverpool) Annual Meeting

Educational Session
Data Monitoring Committees (DMCs): Member Responsibilities and Interpretation of DMC Reports for Effective Decision-Making

Session Details

Rebecca DerSimonian
2017 (Liverpool) Annual Meeting

Session Proposal
Data Monitoring Committees: Current Issues and Challenges

Session Details

Raymond Bain, Ph.D.
2017 (Liverpool) Annual Meeting

Educational Session
Data Monitoring Committees: Multi-stakeholder Recommendations and Hands-on Experience from CTTI and the MRCT Center

Session Details

Katie Flaherty
2017 (Liverpool) Annual Meeting

Contributed Session
Data validation traffic light system: data from the Tranexamic acid for IntraCerebral Haemorrhage (TICH-2) trial.

Session Details

Chris Harbron
2017 (Liverpool) Annual Meeting

Contributed Session
Decision Making in the Face of Biomarker Uncertainty

Session Details

Sharon Kean
2017 (Liverpool) Annual Meeting

Contributed Session
Decisions, decisions: bespoke EDC?

Session Details

Peter Kaufmann
2017 (Liverpool) Annual Meeting

Contributed Session
Decomposing the effects of the study population on null results: the Look AHEAD trial.

Session Details

Andrew Forbes
2017 (Liverpool) Annual Meeting

Contributed Session
Decomposition of the treatment effect estimator in stepped wedge trials: Understanding the horizontal and vertical contributions

Session Details

Babak Choodari-Oskooei
2017 (Liverpool) Annual Meeting

Contributed Session
DEFINING THE FAMILY OF PAIRWISE COMPARISONS IN MULTI-ARM MULTI-STAGE (MAMS) PLATFORM TRIALS

Session Details

Sarah Gaussoin
2017 (Liverpool) Annual Meeting

Contributed Session
Dementia Outcomes After Addition of Proxy-based Assessments for Deceased or Proxy-dependent Participants

Session Details

Yuanyuan Kong
2017 (Liverpool) Annual Meeting

Contributed Session
Demographic and Baseline Characteristics of Patients in China Registry of Hepatitis B (CR-HepB)

Session Details

Jenny Donovan
2017 (Liverpool) Annual Meeting

Contributed Session
Demonstrating the external validity of a randomised controlled trial: the design and generalizability of the ProtecT prostate cancer trial

Session Details

Ian White
2017 (Liverpool) Annual Meeting

Educational Session
Demystifying causal inference: Assessing efficacy when patients depart from randomised treatments

Session Details

Miss Conroy
2017 (Liverpool) Annual Meeting

Contributed Session
Design and analysis of the learning curve and clustering effects in randomised surgical trials – a review of current practice

Session Details

Rema Raman, PhD
2017 (Liverpool) Annual Meeting

Session Proposal
Design and Biostatistical Considerations in Alzheimer’s Disease clinical trials

Session Details

Rick Chappell
2017 (Liverpool) Annual Meeting

Session Proposal
Design and conduct of Oncology Clinical Trials: A Session in Memory of Daniel J. Sargent (1970-2016)

Session Details

Richard Holubkov
2017 (Liverpool) Annual Meeting

Contributed Session
DESIGN AND COORDINATION OF THE DECAAF II RANDOMIZED INTERNATIONAL TRIAL

Session Details

Wenle Zhao
2017 (Liverpool) Annual Meeting

Educational Session
Design and implementation of better and simple randomization algorithms with low allocation predictability, accurate allocation targeting, and strong baseline covariate balancing

Session Details

Lehana Thabane
2017 (Liverpool) Annual Meeting

Session Proposal
Design and Methodological Issues in Registry-based Randomized Controlled Trials

Session Details

Isoken Odia
2017 (Liverpool) Annual Meeting

Contributed Session
DESIGN ISSUES OF A NON-INFERIORITY TRIAL: Prompt Panretinal Photocoagulation Versus Intravitreous Ranibizumab for Proliferative Diabetic Retinopathy (A tale of Two Diseases)

Session Details

Kristian Brock
2017 (Liverpool) Annual Meeting

Contributed Session
Design of a practice-changing trial in the ultra-rare condition of Wolfram Syndrome

Session Details

Mary Redman
2017 (Liverpool) Annual Meeting

Contributed Session
Design, conduct, and analysis of a master protocol within an evolving landscape of standard of care: The Lung-MAP Trial

Session Details

Mark Espeland
2017 (Liverpool) Annual Meeting

Contributed Session
Designing Clinical Trials with Age-Related Multiple Morbidity Outcomes

Session Details

Eftychia Psarelli
2017 (Liverpool) Annual Meeting

Contributed Session
Designing trial outcomes for rare diseases

Session Details

Sujata Patil
2017 (Liverpool) Annual Meeting

Contributed Session
Designing trials that aim to evaluate therapies that target brain metastases in cancer patients: challenges and recommendations

Session Details

Deborah Donnell
2017 (Liverpool) Annual Meeting

Contributed Session
Detection of incomplete data in surveillance and impact of missing data in assessment of effectiveness of financial incentives of viral load suppression in HPTN 065

Session Details

Alexina Mason
2017 (Liverpool) Annual Meeting

Contributed Session
Developing a Bayesian adaptive design for a Phase I clinical trial: a case study for a novel HIV treatment

Session Details

Megan Wirth
2017 (Liverpool) Annual Meeting

Contributed Session
Developing a Comprehensive Site Selection Process for a Cancer Network in a Resource-Limited Settings in Sub-Saharan Africa

Session Details

Lydia Emerson
2017 (Liverpool) Annual Meeting

Contributed Session
Developing a framework to aid purposive sampling in process evaluation of a critical care trial

Session Details

Kayla Daniels
2017 (Liverpool) Annual Meeting

Contributed Session
Developing a Web-Based Central Laboratory Shipment Scheduler and Information System

Session Details

Martin Landray
2017 (Liverpool) Annual Meeting

Contributed Session
DEVELOPING NOVEL ENDPOINTS, GENERATED USING MOBILE TECHNOLOGY, FOR USE IN CLINICAL TRIALS: A CLINICAL TRIALS TRANSFORMATION INITIATIVE (CTTI) PROJECT

Session Details

Martin Landray
2017 (Liverpool) Annual Meeting

Session Proposal
Developing Novel Endpoints, Generated using Mobile Technology, for use in Clinical Trials: A Clinical Trials Transformation Initiative (CTTI) Project

Session Details

Jonathan Gibb
2017 (Liverpool) Annual Meeting

Contributed Session
Developing Tablet Based EDC Apps

Session Details

Athanasia Gravani
2017 (Liverpool) Annual Meeting

Contributed Session
DEVELOPMENT AND FIRST EVALUATION OF THE ATLAS TRAINING TOOLKIT FOR CLINICAL TRIALS

Session Details

Helen Richmond
2017 (Liverpool) Annual Meeting

Contributed Session
Development of a complex exercise intervention for prevention of shoulder dysfunction in high-risk women following treatment for breast cancer: PReventionOf Shoulder ProblEms tRial (PROSPER)

Session Details

Vikki Wylde
2017 (Liverpool) Annual Meeting

Contributed Session
Development of a complex intervention for patients with chronic pain after knee replacement

Session Details

Sarah Lawton
2017 (Liverpool) Annual Meeting

Contributed Session
Development of a Health Informatics Working Group to enhance the conduct of Clinical Trials in Primary Care

Session Details

Sharon Kean
2017 (Liverpool) Annual Meeting

Contributed Session
Development of a safe haven analytical platform

Session Details

Susanne Finnegan
2017 (Liverpool) Annual Meeting

Contributed Session
Development of complex interventions to prevent falls and fractures in older people living in the community: The Prevention of Fall Injury Trial (PreFIT)

Session Details

Michael Schlussel
2017 (Liverpool) Annual Meeting

Contributed Session
DEVELOPMENT OF THE CORKA TRIAL SCREENING TOOL FOR IDENTIFYING PATIENTS AT INCREASED RISK OF POOR OUTCOME FOLLOWING KNEE REPLACEMENT

Session Details

Julie Duncan Millar
2017 (Liverpool) Annual Meeting

Contributed Session
Development of the Standardising Measures in Arm Rehabilitation Trials for stroke (SMART) Toolbox (Work in progress)

Session Details

Amber Randall
2017 (Liverpool) Annual Meeting

Contributed Session
DMC Report Production: Considering a Risk-Based Approach to Quality Control

Session Details

Jessica Wood
2017 (Liverpool) Annual Meeting

Contributed Session
Do higher monetary incentives improve response rates part-way through a randomised control trial?

Session Details

Jackie Martin-Kerry
2017 (Liverpool) Annual Meeting

Contributed Session
Do multimedia resources increase the quality of information provision and rate of recruitment in trials involving children and adolescents?: Protocol for the TRECA study

Session Details

Lauren Greenberg
2017 (Liverpool) Annual Meeting

Contributed Session
Do trialists adequately pre-specify their statistical analysis approach? A review and re-analysis

Session Details

Adwoa Hughes-Morley
2017 (Liverpool) Annual Meeting

Contributed Session
Does advertising patient and public involvement in a trial to potential participants improve recruitment and response rates? An embedded cluster randomised trial

Session Details

Lucy Culliford
2017 (Liverpool) Annual Meeting

Contributed Session
Does appearance matter? A study within a study

Session Details

Richard Holubkov
2017 (Liverpool) Annual Meeting

Contributed Session
DSMB Monitoring of the Therapeutic Hypothermia After Pediatric Cardiac Arrest (THAPCA) Trials

Session Details

Ashley Hogan
2017 (Liverpool) Annual Meeting

Contributed Session
Dynamic Manuscript Development and Tracking for Clinical Trial Publications

Session Details

Gian Luca Di Tanna
2017 (Liverpool) Annual Meeting

Contributed Session
Economic evaluation alongside Stepped Wedge Trials: a systematic review and a proposal of analysis

Session Details

Allison Furey
2017 (Liverpool) Annual Meeting

Contributed Session
Effective Graphical Analyses of Adverse Events in DMC Reports

Session Details

Sean Strong
2017 (Liverpool) Annual Meeting

Contributed Session
Effective teamwork is crucial to maximising recruitment to randomised controlled trials in surgical oncology

Session Details

Seonaidh Cotton
2017 (Liverpool) Annual Meeting

Contributed Session
Efficiencies in multi-centre RCTs – what lessons can be learned from a trial with more than 100 recruitment sites?

Session Details

Kris McGill
2017 (Liverpool) Annual Meeting

Contributed Session
Efficiency of Recruitment to Stroke Rehabilitation Randomised Controlled Trials: Secondary Analysis of Recruitment Data

Session Details

Toshimitsu Hamasaki
2017 (Liverpool) Annual Meeting

Contributed Session
Efficient group-sequential designs for monitoring two time-to-event outcomes in clinical trials

Session Details

Charlotte Friend
2017 (Liverpool) Annual Meeting

Contributed Session
Electronic data capture; changing data management at ICR-CTSU

Session Details

Debra Housel
2017 (Liverpool) Annual Meeting

Session Proposal
Electronic Medical Record (EMR) Use in Clinical Research Monitoring: Challenges and Solutions

Session Details

Pamela Tenaerts
2017 (Liverpool) Annual Meeting

Contributed Session
Embedding Randomized Clinical Trials within Registries: How Feasible?

Session Details

Suzanne Hartley
2017 (Liverpool) Annual Meeting

Contributed Session
Embedding trials into established service improvement initiatives: challenges and lessons from an implementation laboratory.

Session Details

Yuanyuan Liang
2017 (Liverpool) Annual Meeting

Contributed Session
Engaging hard-to-reach communities for community-partnered research: A comparison of two non-probability sampling methods

Session Details

Jonathan Gibb
2017 (Liverpool) Annual Meeting

Contributed Session
Ensuring a GCP compliant audit trail for EDC/EPROM

Session Details

Amanda Lilley-Kelly
2017 (Liverpool) Annual Meeting

Contributed Session
ENSURING RESEARCH QUALITY IN CARE HOME TRIALS: LEARNING FROM NHS GOVERNANCE PROCEDURES

Session Details

Amanda Lilley-Kelly
2017 (Liverpool) Annual Meeting

Session Proposal
Ensuring Research quality in Care Home trials: Learning from NHS governance procedures

Session Details

Laura Lovato
2017 (Liverpool) Annual Meeting

Educational Session
Essentials of Randomized Clinical Trials

Session Details

Charles Opondo
2017 (Liverpool) Annual Meeting

Contributed Session
Estimating intervention effect in cluster randomised controlled trials with non-compliance

Session Details

Kirsty Garfield
2017 (Liverpool) Annual Meeting

Contributed Session
Estimating the cost of prescribed medications in economic evaluation: does the current method reflect the true cost to the English NHS? Evidence from the COMET feasibility study.

Session Details

Laura Mandefield
2017 (Liverpool) Annual Meeting

Contributed Session
Estimating the underlying overall and centre recruitment rates in external pilot trials- how many centre-months of recruitment data do we need? A case study of the BEADS pilot trial.

Session Details

Cory Goldstein
2017 (Liverpool) Annual Meeting

Contributed Session
Ethical issues in individual-cluster trials: beyond the Ottawa Statement

Session Details

Thomas Jaki
2017 (Liverpool) Annual Meeting

Session Proposal
Evaluating medicines when recruitment is ethically and/or practically challenging

Session Details

Matthias Pierce
2017 (Liverpool) Annual Meeting

Contributed Session
Evaluating personalised treatment recommendations using randomised controlled trials

Session Details

Caroline Fairhurst
2017 (Liverpool) Annual Meeting

Contributed Session
Evaluating the effectiveness of remote versus on-site initiation visits: an embedded randomised controlled feasibility cluster trial within the SWIFFT trial

Session Details

Antonia Marsden
2017 (Liverpool) Annual Meeting

Contributed Session
Evaluating treatment effect modification on the additive scale for the evaluation of predictive markers

Session Details

Laurent Billot
2017 (Liverpool) Annual Meeting

Contributed Session
Evaluation of a state-wide chronic disease management program on health service utilisation using a propensity-matched control group

Session Details

Federico Rotolo
2017 (Liverpool) Annual Meeting

Contributed Session
Evaluation of Failure Time Surrogate Endpoints in Individual Patient Data Meta-Analyses of randomized clinical trials. A Poisson Approach

Session Details

Katie Gillies
2017 (Liverpool) Annual Meeting

Contributed Session
EvaLuation of Interventions for informed Consent for randomIsed controlled Trials (ELICIT): results from a systematic review and interviews towards developing a core outcome set.

Session Details

Deirdre Hurley
2017 (Liverpool) Annual Meeting

Contributed Session
Evaluation of Recruitment Procedures to the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) cluster randomised controlled feasibility trial [ISRCTN 49875385]

Session Details

David Beard
2017 (Liverpool) Annual Meeting

Contributed Session
Evidence based evaluation of practice using the IDEAL-Physio framework. A strategic method of evaluating innovation and current practice.

Session Details

Rebecca Haydock
2017 (Liverpool) Annual Meeting

Contributed Session
Evolution of a recruitment strategy between secondary and primary care during the recruitment phase of the Fourfold Asthma (FAST) Trial

Session Details

Sandra Galvin
2017 (Liverpool) Annual Meeting

Session Proposal
Exemplars of the successful involvement of the public in randomised trial design.

Session Details

Gillian Gyte
2017 (Liverpool) Annual Meeting

Contributed Session
Explaining randomisation to potential clinical trial participants

Session Details

Neil Corrigan
2017 (Liverpool) Annual Meeting

Contributed Session
Exploring and adjusting for potential learning effects in ROLARR - a randomised controlled surgical trial

Session Details

Amarnath Vijayarangan
2017 (Liverpool) Annual Meeting

Contributed Session
Exploring Automated Free SMS from Email in Clinical Trials

Session Details

Jennifer Liddle
2017 (Liverpool) Annual Meeting

Contributed Session
Exploring discrepancies between long-term condition review consultation audio-recordings and computer template data (the ENHANCE pilot trial)

Session Details

Paulina Szymczynska
2017 (Liverpool) Annual Meeting

Contributed Session
Exploring Retention Challenges and Strategies in Psychosis Trials: Patient and Trialist Perspectives

Session Details

Joanne Chalmers
2017 (Liverpool) Annual Meeting

Contributed Session
Exploring the impact of priority setting partnerships in skin disease

Session Details

Richard Hellyar
2017 (Liverpool) Annual Meeting

Contributed Session
Exploring understanding of Neural Stem Cell Transplantation (NSCT) as an intervention for Huntington’s disease (HD)

Session Details

Denise Esserman
2017 (Liverpool) Annual Meeting

Contributed Session
Extending the Two-Stage Patient Preference Design for Binary Outcomes with Stratification

Session Details

Iftekhar Khan
2017 (Liverpool) Annual Meeting

Contributed Session
Extrapolation of Utilities Between Disease Progression and Death in Cancer Trials for Economic Evaluation

Session Details

Danielle Edwards
2017 (Liverpool) Annual Meeting

Contributed Session
Factors influencing recruitment in large randomised trials

Session Details

Frances Sherratt
2017 (Liverpool) Annual Meeting

Contributed Session
Family perspectives on the feasibility of a corticosteroid induction regimen randomised controlled trial in juvenile idiopathic arthritis: Results of a qualitative study.

Session Details

Rebecca Barnes
2017 (Liverpool) Annual Meeting

Contributed Session
Footprints in Primary Care: Using mixed methods to assess fidelity to a complex intervention for frequently attending patients

Session Details

Amy Corneli
2017 (Liverpool) Annual Meeting

Contributed Session
Formative Research Findings on the Design of an Early Enrollment Clinical Trial on Hospital-Acquired Bacterial Pneumonia (HABP) and Ventilator-Associated Bacterial Pneumonia (VABP)

Session Details

Paula Darby Lipman
2017 (Liverpool) Annual Meeting

Contributed Session
Framing the Conversation: Use of PRECIS-2 ratings to advance understanding of pragmatic trial design domains

Session Details

Lucy Bradshaw
2017 (Liverpool) Annual Meeting

Contributed Session
Frequency of data collection in a randomised controlled trial for long term eczema management in children

Session Details

Nelson Kinnersley
2017 (Liverpool) Annual Meeting

Contributed Session
From molecule to medicine: a case study in how a statistician can provide strategic input to drug development

Session Details

Rick Grobbee
2017 (Liverpool) Annual Meeting

Session Proposal
From the concept of pragmatic trials to a pragmatic and feasible study protocol

Session Details

Lisa Douet
2017 (Liverpool) Annual Meeting

Contributed Session
Funding innovative study designs – The Efficacy and Mechanism Evaluation Programme

Session Details

Claire Boyle
2017 (Liverpool) Annual Meeting

Contributed Session
FUNNEL PLOTS FOR STATISTICAL QUALITY CONTROL IN A LARGE, MULTI-SITE REGISTRY

Session Details

Claire Diver
2017 (Liverpool) Annual Meeting

Contributed Session
Gatekeeping amongst allied health professionals: recruitment in stem cell trial of recovery enhancement-3 (STEMS-3) feasibility study

Session Details

James Glasbey
2017 (Liverpool) Annual Meeting

Contributed Session
Generating student recruiters for randomised trials in surgery (GRANULE): A one-day course to empower a cohort of future surgical trialists

Session Details

Tracey Davidson
2017 (Liverpool) Annual Meeting

Contributed Session
Going Green whilst maximising questionnaire response rates. Does size matter?

Session Details

Sarah Lawton
2017 (Liverpool) Annual Meeting

Contributed Session
Good order is the foundation of all things: A strong project management structure underpins successful research at Keele CTU

Session Details

Yi-Da Chiu
2017 (Liverpool) Annual Meeting

Contributed Session
Graphical display techniques for subgroup analysis

Session Details

Colin Everett
2017 (Liverpool) Annual Meeting

Contributed Session
Graphical presentation of regression model diagnostics arising from using multiple imputation

Session Details

Danni Liu
2017 (Liverpool) Annual Meeting

Contributed Session
Group Sequential Methods for Monitoring Multi-Arm Clinical Trials

Session Details

Danila Azzolina
2017 (Liverpool) Annual Meeting

Contributed Session
HANDLING MISSING OR INCOMPLETE DATA IN A BAYESIAN NETWORK META-ANALYSIS FRAMEWORK

Session Details

Danila Azzolina
2017 (Liverpool) Annual Meeting

Contributed Session
Handling poor accrual in adaptive trial setting: Bayesian Interim analysis of RESCUE Trial

Session Details

Joanna Thorn
2017 (Liverpool) Annual Meeting

Contributed Session
Health economics analysis plans: the current state of play

Session Details

Jonathan Deeks
2017 (Liverpool) Annual Meeting

Contributed Session
How accurately do trialists pre-specify sample sizes for test evaluation trials? The experience in NIHR funded trials in the HTA and EME programmes.

Session Details

John Gregson
2017 (Liverpool) Annual Meeting

Contributed Session
How and when do competing risks influence results from clinical trials?

Session Details

Melanie Bell
2017 (Liverpool) Annual Meeting

Contributed Session
How are researchers handling missing data in noninferiority trials? A systematic review

Session Details

Rejina Verghis
2017 (Liverpool) Annual Meeting

Contributed Session
How are Surrogate Outcomes defined in Critical Care Trials? Preliminary results of a systematic review

Session Details

Professor Paula Williamson
2017 (Liverpool) Annual Meeting

Session Proposal
How can a trialist appraise and make use of core outcome sets and the COMET database?

Session Details

Peter Bower
2017 (Liverpool) Annual Meeting

Contributed Session
How can incentives be designed and used to improve recruitment and retention in ways that are effective, efficient and ethical?

Session Details

Carmel Conefrey
2017 (Liverpool) Annual Meeting

Contributed Session
How do recruiters present randomisation during trial recruitment? An evaluation of current practice

Session Details

William Aitchison
2017 (Liverpool) Annual Meeting

Contributed Session
How do you detect and deal with compromised EDC accounts?

Session Details

Siew Wan Hee
2017 (Liverpool) Annual Meeting

Contributed Session
How does prevalence affect the size of clinical trials for treatments of rare diseases?

Session Details

Daisy Elliott
2017 (Liverpool) Annual Meeting

Contributed Session
How evidence is presented to potential participants in RCT recruitment consultations

Session Details

Fang-Shu Ou
2017 (Liverpool) Annual Meeting

Contributed Session
How frequently should a disease be monitored? The interval length between observations in interval-censored data

Session Details

Joanna Crocker
2017 (Liverpool) Annual Meeting

Contributed Session
How might patient and public involvement (PPI) improve recruitment and retention in surgical trials? A qualitative study exploring the views of trial staff and PPI contributors

Session Details

Paul Wakim
2017 (Liverpool) Annual Meeting

Educational Session
How to avoid common errors related to design, statistical analysis and reporting of results of clinical trials

Session Details

Professor Paul Brocklehurst
2017 (Liverpool) Annual Meeting

Session Proposal
How to design implementation into your trial from the outset

Session Details

Trish Groves
2017 (Liverpool) Annual Meeting

Educational Session
How to reduce research waste through publishing trials and protocols: an editor's guide

Session Details

Joshua Feinberg
2017 (Liverpool) Annual Meeting

Contributed Session
IDEAL Framework and Recommendations: A literature review of its utilization by surgical innovators since 2009

Session Details

Caroline Kristunas
2017 (Liverpool) Annual Meeting

Contributed Session
Identification of participants for a questionnaire and interview study investigating the feasibility issues encountered during stepped-wedge cluster randomised trials.

Session Details

Anna Kearney
2017 (Liverpool) Annual Meeting

Contributed Session
Identifying effective retention strategies: A research agenda

Session Details

Daniel Hill-McManus
2017 (Liverpool) Annual Meeting

Contributed Session
Identifying the optimal clinical pharmacological properties of potential future medicines using clinical trial simulation

Session Details

Paul Thompson
2017 (Liverpool) Annual Meeting

Contributed Session
Image Modification Journaling for Reproducibility and Fraud Prevention

Session Details

David Raunig
2017 (Liverpool) Annual Meeting

Contributed Session
Imaging endpoint eligibility in oncology trials: What works and what doesn’t

Session Details

Kirsty Loudon
2017 (Liverpool) Annual Meeting

Contributed Session
Impact case study: Using PRECIS-2 to discuss the design of a pilot and feasibility study - Summary of Swallowing intervention Package (SiP)

Session Details

Kevin Fain
2017 (Liverpool) Annual Meeting

Contributed Session
Impact of Results Reporting in ClinicalTrials.gov

Session Details

Paul Brocklehurst
2017 (Liverpool) Annual Meeting

Contributed Session
Implementation in dental trials: an exploration of trial meta-processes

Session Details

RANI JAYSWAL
2017 (Liverpool) Annual Meeting

Contributed Session
Implementation into Practice of Isotonic Regression for Simultaneous Assessment of Toxicity and Pharmacodynamic Endpoints in a Dose Escalation Trial

Session Details

Helen Richmond
2017 (Liverpool) Annual Meeting

Contributed Session
Implementation into practice: the development, enhancement and delivery of an online training programme to support clinicians in the replication of the Back Skills Training (BeST) Programme in practice

Session Details

Catherine Dillon
2017 (Liverpool) Annual Meeting

Contributed Session
Implementation of CTMS Functionality for Remote Monitoring of Informed Consents

Session Details

Steven Weiner
2017 (Liverpool) Annual Meeting

Contributed Session
Implementation of Strategies to Improve Collection of a Challenging Laboratory Outcome in the Delivery Room

Session Details

Lucy Bailey
2017 (Liverpool) Annual Meeting

Contributed Session
Implementing a Risk Based Monitoring Approach In The Early Phase Myeloma Portfolio at Leeds CTRU

Session Details

Cody Chiuzan
2017 (Liverpool) Annual Meeting

Session Proposal
Implementing adaptive designs: balancing the practical with the statistical

Session Details

Duncan Appelbe
2017 (Liverpool) Annual Meeting

Contributed Session
Implementing and Running an online Trial – A case study using The REACT Trial

Session Details

Ashley Hogan
2017 (Liverpool) Annual Meeting

Contributed Session
Implementing Mobile Electronic Patient Reported Outcomes (ePRO) in a Long-Term Trial with an Aging and Diverse Population

Session Details

Alba Realpe
2017 (Liverpool) Annual Meeting

Contributed Session
Implementing training for recruiters based on a new simple six-step model to promote information sharing and recruitment to RCTs: Challenges and opportunities.

Session Details

Rosie Harris
2017 (Liverpool) Annual Meeting

Contributed Session
Improving data quality though routine automated reporting using standard statistical software

Session Details

Matthew Sydes
2017 (Liverpool) Annual Meeting

Contributed Session
IMPROVING KAPLAN–MEIER GRAPHS: BETTER PRESENTATION OF NUMBERS-AT-RISK, CUMULATIVE EVENTS AND MEASURES OF UNCERTAINTY

Session Details

Jon Steingrimsson
2017 (Liverpool) Annual Meeting

Contributed Session
Improving Precision by Adjusting for Prognostic Baseline Variables in Randomized Trials with Binary Outcomes, without Regression Model Assumptions

Session Details

Efstathia Gkioni
2017 (Liverpool) Annual Meeting

Contributed Session
Improving the planning and monitoring of recruitment to clinical trials

Session Details

Carmen Rosa
2017 (Liverpool) Annual Meeting

Contributed Session
Improving the quality of NIH funded clinical trials

Session Details

Song Yang
2017 (Liverpool) Annual Meeting

Contributed Session
Improving the testing of treatment effect in clinical trials with time to event outcomes

Session Details

Dorota Juszczyk
2017 (Liverpool) Annual Meeting

Contributed Session
Incorporating electronic health records data into efficient trial interventions. Cluster randomised trial to reduce antibiotic prescribing in primary care.

Session Details

Madeleine Hurd
2017 (Liverpool) Annual Meeting

Contributed Session
Increasing follow-up response among parents of very preterm infants: personalised contact, external promotion, and web-based questionnaires

Session Details

Chris Cook
2017 (Liverpool) Annual Meeting

Contributed Session
Increasing the availability of statistical tools through mobile development

Session Details

Lucy Bradshaw
2017 (Liverpool) Annual Meeting

Contributed Session
Independent Adjudication of Neonatal Cranial Ultrasound Scans in a Pilot Randomised Trial

Session Details

Janet Wittes (Moderator)
2017 (Liverpool) Annual Meeting

Educational Session
Independent Data Monitoring Committee Reports: A Practical Guide for Reporting Statisticians

Session Details

Sally Hopewell
2017 (Liverpool) Annual Meeting

Contributed Session
Influence of peer review on the reporting of primary outcome(s) and statistical analyses of randomised trials

Session Details

Tao Chen
2017 (Liverpool) Annual Meeting

Contributed Session
Influence of primary outcome change on treatment effect estimates in clinical trials: meta-epidemiological study

Session Details

Victoria Shepherd
2017 (Liverpool) Annual Meeting

Contributed Session
Informed consent and proxy decision making for research involving adults lacking capacity: a systematic review (framework synthesis)

Session Details

Claire Rourke
2017 (Liverpool) Annual Meeting

Contributed Session
Informed consent in acute trauma resuscitation: Experiences of a major trauma centre

Session Details

Matthew Wright
2017 (Liverpool) Annual Meeting

Contributed Session
Informed consent process enhancement approaches for research participants who may be considered vulnerable populations

Session Details

Kaitlyn Antonelli
2017 (Liverpool) Annual Meeting

Contributed Session
Initial Experience with a Virtual Molecular Tumor Board in a Pragmatic Precision Medicine Study

Session Details

Nia Goulden
2017 (Liverpool) Annual Meeting

Contributed Session
Integrating continuous stratification variables into a dynamic adaptive randomisation algorithm

Session Details

Simon Bacon
2017 (Liverpool) Annual Meeting

Contributed Session
Integration of Patients, Caregivers and Healthcare Providers into a Hypertension Management Research Priorities Process

Session Details

Gareth McCray
2017 (Liverpool) Annual Meeting

Contributed Session
Internal pilot sample size re-estimation in paired comparative diagnostic accuracy trials with a binary response

Session Details

Jacqueline Hill
2017 (Liverpool) Annual Meeting

Contributed Session
Intervention development and treatment success in randomised controlled trials of rehabilitation

Session Details

Lucy Bradshaw
2017 (Liverpool) Annual Meeting

Contributed Session
Intra and inter-observer agreement in the interpretation of preterm neonatal cranial ultrasound scans

Session Details

Brittney Bailey
2017 (Liverpool) Annual Meeting

Contributed Session
Investigating Multiple Imputation in Cluster Randomized Trials

Session Details

Wei Tan
2017 (Liverpool) Annual Meeting

Contributed Session
Investigating recruitment imbalance in EXPONATE, a cluster randomised trial

Session Details

Peter Godolphin
2017 (Liverpool) Annual Meeting

Contributed Session
Investigating the effect of independent blinded digital image assessment on the STOP GAP trial

Session Details

Nada Elbeltagi
2017 (Liverpool) Annual Meeting

Contributed Session
Investigating the impact of phase II trial design parameters on the ability to successfully screen new treatments for phase III trials

Session Details

Gemma Clayton
2017 (Liverpool) Annual Meeting

Contributed Session
Investigating the use of evidence synthesis in the design and analysis of clinical trials

Session Details

Leila Rooshenas
2017 (Liverpool) Annual Meeting

Contributed Session
Is it possible to randomise patients to potentially not receive a dressing after surgery? Preliminary findings of the NIHR HTA Bluebelle pilot randomised controlled trial

Session Details

Heather Morgan
2017 (Liverpool) Annual Meeting

Contributed Session
Is that it? – using ‘Explorachoc’ to engage the public with clinical trials and health services research

Session Details

Helen Myers
2017 (Liverpool) Annual Meeting

Contributed Session
Is there anyone so wise as to learn by the experience of others? Developing and implementing a ‘Lessons Learnt’ database in a Clinical Trials Unit.

Session Details

Meredith Martyn
2017 (Liverpool) Annual Meeting

Contributed Session
Issues with Over-fitting in Predictive Models Produced for Stratified Medicine: A Case Study on an Ovarian Cancer Trial

Session Details

Katherine Fairhurst
2017 (Liverpool) Annual Meeting

Contributed Session
Key design features of pilot and feasibility studies to inform successful surgical trials: A systematic analysis of funded studies.

Session Details

Lisa Reeves
2017 (Liverpool) Annual Meeting

Contributed Session
Keys to Successful Participant Response Rates in a 30 year Longitudinal Study

Session Details

Emily Graham
2017 (Liverpool) Annual Meeting

Contributed Session
Late stage combination drug development for improved portfolio-level decision-making

Session Details

J. Jack Lee, Ph.D.
2017 (Liverpool) Annual Meeting

Educational Session
Learning Bayesian Methods and Adaptive Designs: Concepts, Tools, and Applications

Session Details

Catherine Arundel
2017 (Liverpool) Annual Meeting

Contributed Session
Learning from the OCTET Trial - Exploring acceptability of clinical trials management

Session Details

Adwoa Hughes-Morley
2017 (Liverpool) Annual Meeting

Contributed Session
Learning lessons from trial decliners about improving recruitment: qualitative study

Session Details

David Preiss
2017 (Liverpool) Annual Meeting

Contributed Session
LENS – a clinical trial embedded in routine clinical practice to reduce the burden of diabetic eye disease

Session Details

Rachel Phillips
2017 (Liverpool) Annual Meeting

Contributed Session
Lessons to learn from the reporting of adverse events (AEs) in randomised controlled trials published in high impact journals.

Session Details

Radhika Kondapaka
2017 (Liverpool) Annual Meeting

Contributed Session
Leveraging Electronic Data Capture (EDC) Systems to Optimize Pharmacovigilance in Clinical Trials

Session Details

Mansour Sharabiani
2017 (Liverpool) Annual Meeting

Contributed Session
Log-Likelihood is the best correlative measure to estimate the cutpoint for a continuous prognostic variable: A Monte Carlo simulation study

Session Details

Maiken Pontoppidan
2017 (Liverpool) Annual Meeting

Contributed Session
Long Term Results Of the Incredible Years Parents And Babies Program– A Randomized Controlled Pilot Trial Of A Universal Parenting Intervention In Denmark

Session Details

Virginia Chiocchia
2017 (Liverpool) Annual Meeting

Contributed Session
Machine perfusion in liver transplantation: practical issues to consider in the design and conduct of a complex multinational interventional trial and the potential impact on the analysis

Session Details

Paul Whybrow
2017 (Liverpool) Annual Meeting

Contributed Session
Maintaining Recruitment and Informed Consent in the Advanced Stages of a Trial: the By-Band-Sleeve Study

Session Details

Liz Tremain
2017 (Liverpool) Annual Meeting

Contributed Session
Managed access to NIHR-funded research data: An opportunity for all?

Session Details

T. Charles Casper
2017 (Liverpool) Annual Meeting

Educational Session
Managing Manuscripts Efficiently in Multicenter Trials

Session Details

Carlos Diaz-Montana
2017 (Liverpool) Annual Meeting

Contributed Session
Managing our TEMPER: Monitoring triggers and site matching algorithms for defining triggered and control sites in the TEMPER study

Session Details

Gwenllian Moody
2017 (Liverpool) Annual Meeting

Contributed Session
Managing the challenge of recruiting foster carers into a trial of a supportive group-based social care intervention: lessons learned from the Confidence in Care trial.

Session Details

James Barrett
2017 (Liverpool) Annual Meeting

Contributed Session
Matching the right patient to the right clinical study: the opportunities for more efficient clinical studies using selective-recruitment designs.

Session Details

Linda Sharples
2017 (Liverpool) Annual Meeting

Contributed Session
Maximising information in pressure ulcer prevention trials using multi-state modelling

Session Details

Dr Athene
2017 (Liverpool) Annual Meeting

Contributed Session
Maximising participant retention and outcome data in a long term cancer trial (ProtecT)

Session Details

Samantha Cruz Rivera
2017 (Liverpool) Annual Meeting

Contributed Session
Maximising research impact: a systematic review of research impact frameworks

Session Details

Gordon Forbes
2017 (Liverpool) Annual Meeting

Contributed Session
Maximising the relevance of randomised trials to primary care

Session Details

Lauren Scott
2017 (Liverpool) Annual Meeting

Contributed Session
Maximising trial efficiency in the Airways-2 trial using a multi-functional database

Session Details

Louise Hiller
2017 (Liverpool) Annual Meeting

Contributed Session
Measurement methods for eliciting opinions on treatment benefits, toxicities and acceptable trade-offs of the two, within the PERSEPHONE trial

Session Details

Deborah DiLiberto
2017 (Liverpool) Annual Meeting

Contributed Session
Mediation Analysis to Explore Causal Mechanisms in Trials of Complex Interventions

Session Details

Brent C Opmeer
2017 (Liverpool) Annual Meeting

Educational Session
Methodological and practical considerations in multinational economic evaluation studies

Session Details

Julia Forman
2017 (Liverpool) Annual Meeting

Contributed Session
Methodological challenges in the REACT Study, a randomized controlled trial of Real Time Continuous Glucose monitoring in Neonatal Intensive Care

Session Details

Prof Ken Cheung
2017 (Liverpool) Annual Meeting

Session Proposal
Methods and Practice of Modern Adaptive Dose Finding Trials: A Progress Report

Session Details

Iryna Schlackow
2017 (Liverpool) Annual Meeting

Contributed Session
Methods for extrapolation from clinical trial data to inform economic evaluations: a taxonomy

Session Details

Alice Biggane
2017 (Liverpool) Annual Meeting

Contributed Session
Methods for including patients in core outcome set development

Session Details

Lucy McParland
2017 (Liverpool) Annual Meeting

Contributed Session
Methods for testing for and handling non-proportional hazards in a Phase II RCT in Chronic Lymphocytic Leukaemia

Session Details

Polly Scutt
2017 (Liverpool) Annual Meeting

Contributed Session
Methods for training paramedics to recruit patients into the Rapid intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)

Session Details

Denise Forshaw
2017 (Liverpool) Annual Meeting

Contributed Session
Methods of approaching general practices for trial participant information: feasibility cluster-randomised trial nested within a large multi-centre cluster-randomised controlled cross-over trial

Session Details

Jane Candlish
2017 (Liverpool) Annual Meeting

Contributed Session
Methods to analyse partially nested randomised controlled trials

Session Details

Sian Cousins
2017 (Liverpool) Annual Meeting

Contributed Session
Minimising bias in surgical RCTs through blinding: a systematic review

Session Details

Ken Kelley
2017 (Liverpool) Annual Meeting

Contributed Session
Minimum-risk Point-estimation for the Standardized Mean Difference: A Sequential Estimation Approach

Session Details

Baptiste Leurent
2017 (Liverpool) Annual Meeting

Contributed Session
Missing data in trial-based cost-effectiveness analysis: a review of the current practice

Session Details

Ann-Kristin Leuchs, Federal Institute for Drugs and Medical Devices (BfArM), Germany
2017 (Liverpool) Annual Meeting

Session Proposal
Missing Outcome Data in Randomized Clinical Trials: addressing the challenges to applying principled methods for analysis of causal estimands

Session Details

Charlotte Murkin
2017 (Liverpool) Annual Meeting

Contributed Session
Mixed methods feasibility work to inform data collection in a main study: designing case report forms to capture variation in surgical techniques.

Session Details

Garry Meakin
2017 (Liverpool) Annual Meeting

Contributed Session
Mock activation of a pandemic influenza clinical trial: testing for rapid recruitment

Session Details

Trudie Lang
2017 (Liverpool) Annual Meeting

Session Proposal
Modern methodology to tackle an ancient disease of poverty: Design innovations in tuberculosis clinical trials in resource-poor settings

Session Details

Jason McCoy
2017 (Liverpool) Annual Meeting

Contributed Session
Monitoring Interactive Response Technology Vendor Implemented Randomization and Dosing Systems

Session Details

Emily Harrop
2017 (Liverpool) Annual Meeting

Contributed Session
Motives, meanings and misconceptions: exploring the understandings and experiences of advanced lung cancer patients participating in a non-placebo clinical IMP trial

Session Details

Kerry Hood
2017 (Liverpool) Annual Meeting

Session Proposal
MRC Guidance for complex interventions: intervention development and exploratory / feasibility studies

Session Details

Claire Kerr
2017 (Liverpool) Annual Meeting

Contributed Session
MS SharePoint – Using collaborative software to support collaborative research

Session Details

Ed Juszczak
2017 (Liverpool) Annual Meeting

Contributed Session
MULTI-ARM PARALLEL GROUP TRIALS – NOT A SIMPLE EXTENSION TO 2-ARM TRIALS

Session Details

Peter Knapp
2017 (Liverpool) Annual Meeting

Session Proposal
Multimedia and digital provision of trial participant recruitment information: opportunities and challenges

Session Details

Soeun Kim
2017 (Liverpool) Annual Meeting

Contributed Session
Multiple Imputation for Missing Covariates in Clinical Trials with Interactions

Session Details

Karla DiazOrdaz
2017 (Liverpool) Annual Meeting

Contributed Session
Multiple imputation methods for estimating causal treatment effects in trials with non-compliance

Session Details

Kimberley Goldsmith
2017 (Liverpool) Annual Meeting

Contributed Session
Multiply efficient trials: combining multiple trial arms and critical secondary questions increases trial efficiency

Session Details

Gillian Gresham
2017 (Liverpool) Annual Meeting

Contributed Session
Navigating the ClinicalTrials.gov database: A case study

Session Details

Larisa Tereshchenko
2017 (Liverpool) Annual Meeting

Contributed Session
Network meta-analysis of antiembolic interventions: adjustment for confounders

Session Details

Catherine Klersy
2017 (Liverpool) Annual Meeting

Contributed Session
Network metanalysis benchmarking the technological development of implantable medical devices

Session Details

Claire Cochran
2017 (Liverpool) Annual Meeting

Contributed Session
Networked for sucess? The establishment and maturation of a Trainee Reserach Network within a UK based Opthalmology study

Session Details

Eric Foster
2017 (Liverpool) Annual Meeting

Contributed Session
NeuroNEXT Study Design Working Group Experiences

Session Details

Sandra Eldridge
2017 (Liverpool) Annual Meeting

Contributed Session
New Cochrane risk of bias tool for cluster randomised tools

Session Details

Deborah Ashby
2017 (Liverpool) Annual Meeting

Session Proposal
New guidance on specifying the target difference (“effect size”) for a RCT

Session Details

Ceri Rowlands
2017 (Liverpool) Annual Meeting

Contributed Session
New methods for categorising recruitment research: a case study

Session Details

Phillip Whitehead
2017 (Liverpool) Annual Meeting

Contributed Session
NIHR Clinical Trials Fellowship: Reflections from a fellow and a mentor

Session Details

Mark Mullee
2017 (Liverpool) Annual Meeting

Contributed Session
NIHR Research Design Service

Session Details

Jack Wilkinson
2017 (Liverpool) Annual Meeting

Contributed Session
No common denominator: a review of outcome measures in IVF RCTs.

Session Details

Jessica Kendall
2017 (Liverpool) Annual Meeting

Contributed Session
Non-Stochastic Curtailment in Phase II Oncology Trials

Session Details

Chi Kin Lam
2017 (Liverpool) Annual Meeting

Contributed Session
Nonparametric Overdose Control for Dose Finding in Drug-Combination Trials

Session Details

Jennifer Bell
2017 (Liverpool) Annual Meeting

Contributed Session
Observational versus randomised data: Using a fractional factorial RCT to compare results.

Session Details

Polly Scutt
2017 (Liverpool) Annual Meeting

Contributed Session
Obtaining consent in the pre-hospital setting: consent procedures from the Rapid Intervention with Glyceryl trinitrate in Hypertensive stroke Trial-2 (RIGHT-2)

Session Details

Tolulope Sajobi
2017 (Liverpool) Annual Meeting

Contributed Session
On Synthesis Evidence from Explanatory and Pragmatic trials: A Comparison of Meta-analytic Methods

Session Details

Gina Simone
2017 (Liverpool) Annual Meeting

Educational Session
One Month, Two Studies, Four FDA Audits

Session Details

Anna Kearney
2017 (Liverpool) Annual Meeting

Contributed Session
Online resource for Recruitment Research in Clinical triAls research (ORRCA)

Session Details

Pam Mangat
2017 (Liverpool) Annual Meeting

Contributed Session
Operational Advantages and Challenges with Pragmatic Precision Medicine Trials: The TAPUR Study

Session Details

Sheila Burgard
2017 (Liverpool) Annual Meeting

Contributed Session
Operationalizing and Testing a Minimization Randomization Algorithm for Use in Clinical Trials

Session Details

Sheila Burgard
2017 (Liverpool) Annual Meeting

Contributed Session
Operationalizing the Use of Latent Variables in the Process of Determining an ARIC Participant’s Neurocognitive Status at Visit 6

Session Details

Jeremy Horwood
2017 (Liverpool) Annual Meeting

Contributed Session
Opportunistic trial recruitment during routine primary care consultations for acute conditions: a mixed methods evaluation of recruitment performance and barriers.

Session Details

Pat Hoddinott
2017 (Liverpool) Annual Meeting

Contributed Session
Opportunities and pitfalls encountered when using the Template for Intervention Description and Replication (TIDieR) to develop a complex intervention to reduce obesity in men.

Session Details

Karla Hemming
2017 (Liverpool) Annual Meeting

Session Proposal
Optimality in stepped wedge cluster randomised trials – when and where to take measurements

Session Details

Alison Deary
2017 (Liverpool) Annual Meeting

Contributed Session
Optimising primary outcome data collection in a neonatal trial

Session Details

Warwick Medical School
2017 (Liverpool) Annual Meeting

Educational Session
Optimising setup and recruitment of multicentre complex randomised control trials

Session Details

Talia Isaacs
2017 (Liverpool) Annual Meeting

Contributed Session
Optimising the recruitment of underrepresented ethnic minority patients to telehealth diabetes trials: Examining the role of language and research reporting practices

Session Details

Martina Svobodova
2017 (Liverpool) Annual Meeting

Contributed Session
Optimising trial recruitment with well-designed screening log: experiences from the ROCS Study

Session Details

Rui (Sammi) Tang
2017 (Liverpool) Annual Meeting

Session Proposal
Optimizing Clinical Trials by Using Historical Data and Novel Designs

Session Details

Catherine Dillon
2017 (Liverpool) Annual Meeting

Session Proposal
Optimizing Quality in Clinical Research: Strategies for Preventing Errors in Trial Operation, Study Data, and Human Subjects Protection

Session Details

Caroline Main
2017 (Liverpool) Annual Meeting

Contributed Session
Outcome measurement in paediatric proton beam radiation therapy studies: is greater standardisation needed?

Session Details

junhua zhang
2017 (Liverpool) Annual Meeting

Contributed Session
Outcome Measures in Clinical trials of traditional Chinese medicine for stable angina pectoris

Session Details

Paula Williamson
2017 (Liverpool) Annual Meeting

Contributed Session
Outcome selection in clinical trials – looking back at the problems and moving forward with solutions

Session Details

Julius Sim
2017 (Liverpool) Annual Meeting

Contributed Session
Outcome-adaptive randomization: some ethical issues

Session Details

Mike Clarke (invited)
2017 (Liverpool) Annual Meeting

Session Proposal
Outcomes in Trials and Systematic Reviews: Why we should be paying more attention

Session Details

Amy Ruppert
2017 (Liverpool) Annual Meeting

Contributed Session
Overall Success Rate of a Safe and Efficacious Drug: Results Using Six Phase I Designs, Each Followed by Phase II and III Trials Using Standard Designs

Session Details

Jennie Young
2017 (Liverpool) Annual Meeting

Contributed Session
Overtreatment of DCIS – 4 years on from the Marmot Review - Progress with the LORIS Trial

Session Details

Rachel Phillips
2017 (Liverpool) Annual Meeting

Contributed Session
Overview of statistical methods to monitor harms during the conduct of a randomised controlled trial

Session Details

Claire Vale
2017 (Liverpool) Annual Meeting

Contributed Session
Participant involvement as a form of patient and public involvement in clinical trials: experience, reflections and recommendations

Session Details

RANI JAYSWAL
2017 (Liverpool) Annual Meeting

Contributed Session
Partnership of Cancer Center Core Facilities with Community-Based Research Networks in the Coordination and Management of Multi-Center Clinical Trials

Session Details

Cushla Cooper
2017 (Liverpool) Annual Meeting

Contributed Session
Patient and public involvement into the design of a Paediatric surgical trial: The NINJA study

Session Details

Lucy Selman
2017 (Liverpool) Annual Meeting

Contributed Session
Patient and Public Involvement: An Investigation

Session Details

prof. Kit Roes
2017 (Liverpool) Annual Meeting

Session Proposal
Patient centered outcome measurements in rare disease trials: Challenges and potential solutions

Session Details

Emily Holmes
2017 (Liverpool) Annual Meeting

Contributed Session
Patient preferences for outcomes in clinical trials: implications for medicines optimisation

Session Details

Rachel McNamara
2017 (Liverpool) Annual Meeting

Contributed Session
Patient reported outcome measure development in epilepsy and intellectual disability: A systematic review of measures of anti-epileptic drug side effects

Session Details

Colin Ridyard
2017 (Liverpool) Annual Meeting

Contributed Session
Patient-level information and costing systems (PLICS) as a source of routinely collected cost data for trial-based economic evaluations

Session Details

Annmarie Nelson
2017 (Liverpool) Annual Meeting

Contributed Session
Patients’ experience in adaptive oncology clinical trials: Trial acceptability, feasibility, efficiency, processes and outcomes

Session Details

Rachel Maishman
2017 (Liverpool) Annual Meeting

Contributed Session
Patterns of adverse events after cardiac surgery

Session Details

Heidi Gardner
2017 (Liverpool) Annual Meeting

Contributed Session
Perceptions and experiences of participant recruitment: A qualitative interview study with trial stakeholders

Session Details

Emily OBrien
2017 (Liverpool) Annual Meeting

Contributed Session
Perceptions of the Utility and Barriers of Using Electronic Health Records for Patient Screening in Clinical Trials: An In-Depth Interviews Study of Site Coordinators

Session Details

Roy Elbers
2017 (Liverpool) Annual Meeting

Contributed Session
Performance bias in trials that cannot blind participants and healthcare providers to assigned interventions: implications for trial conduct

Session Details

Deirdre Hurley
2017 (Liverpool) Annual Meeting

Contributed Session
Physiotherapists’ views of the acceptability and feasibility of the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) complex intervention within a cluster randomised controlled feasibility trial [ISRCTN 49875385]

Session Details

Amparo Casanova
2017 (Liverpool) Annual Meeting

Contributed Session
PILOT AND FEASIBILITY STUDIES: A SYSTEMATIC REVIEW OF STUDIES CONDUCTED AT THE POPULATION HEALTH RESEARCH INSTITUTE

Session Details

Lawrence Richer
2017 (Liverpool) Annual Meeting

Contributed Session
Placebo response is not decreased by enrichment trial designs in randomized controlled trials of triptan medications in the paediatric age group

Session Details

Naomi Merritt
2017 (Liverpool) Annual Meeting

Contributed Session
Placebo Surgery Trials in the NHS are Possible

Session Details

Indrani Bhattacharya
2017 (Liverpool) Annual Meeting

Contributed Session
Planned implementation of a study within a trial using a stepped wedge trial design evaluating the introduction of a patient decision aid on decisional conflict in patients’ considering entry into the PRIMETIME study

Session Details

Kukatharmini Tharmaratnam
2017 (Liverpool) Annual Meeting

Contributed Session
Point and interval estimation for predicting individual patients treatment effect based on randomized clinical trial data

Session Details

Barbara E. Bierer, MD
2017 (Liverpool) Annual Meeting

Session Proposal
Post trial access to Investigational Medicines: Policy and Practical Recommendations

Session Details

Rebecca Llewellyn-Bennett
2017 (Liverpool) Annual Meeting

Contributed Session
Post-trial follow-up methodology in large randomized controlled trials: a systematic review

Session Details

Naoki Ishizuka
2017 (Liverpool) Annual Meeting

Contributed Session
Practical sample size re-estimation of propensity score analysis for prospective study.

Session Details

Sharon Ruddock
2017 (Liverpool) Annual Meeting

Contributed Session
Practicalities of obtaining long term follow up data from International Sites

Session Details

Sian Taylor-Phillips
2017 (Liverpool) Annual Meeting

Contributed Session
Pragmatic Integrated Randomised Controlled Trials in Screening: Experience from a trial in 1.2million women attending breast screening

Session Details

Brian Egleston
2017 (Liverpool) Annual Meeting

Contributed Session
Pragmatic verification of cancer clinical trial efficacy findings using the Surveillance Epidemiology and End Results (SEER) database

Session Details

Kirsty Loudon
2017 (Liverpool) Annual Meeting

Educational Session
PRECIS-2 PRECIS-2: Precisely how can this tool help investigators design trials to achieve practical answers to “real world” questions?

Session Details

Dr Andrea Jorgensen
2017 (Liverpool) Annual Meeting

Session Proposal
Precision medicine – addressing the key challenges of demonstrating clinical utility

Session Details

Karan Vadher
2017 (Liverpool) Annual Meeting

Contributed Session
Prediction model for developmental outcome at 2 years of age for babies born very preterm

Session Details

Wendi Qian
2017 (Liverpool) Annual Meeting

Contributed Session
Predictive power in feasibility study design: implementation in the INTERIM melanoma cancer trial

Session Details

Peter Knapp
2017 (Liverpool) Annual Meeting

Contributed Session
Preliminary analysis of a new measure of quality of patient decision making about research participation

Session Details

Tamara Haller
2017 (Liverpool) Annual Meeting

Contributed Session
Presentation and Publication System (PnP): A tool to facilitate efficient tracking and reporting of the presentation and publication process

Session Details

Kerry Woolfall
2017 (Liverpool) Annual Meeting

Contributed Session
Priorities for methodological research on patient and public involvement in clinical trials: a modified Delphi process

Session Details

Healy Patricia
2017 (Liverpool) Annual Meeting

Contributed Session
PRioritising Recruitment in Randomised Trials: The PRioRiTy Study- An Ireland and UK priority setting partnership

Session Details

Sarah Gorst
2017 (Liverpool) Annual Meeting

Contributed Session
Priority setting for core outcome set development

Session Details

Jamie Murdoch
2017 (Liverpool) Annual Meeting

Contributed Session
Process evaluation for the PREPARE-ABC study: context mapping, pinchpoints and implications for implementation and theoretical fidelity.

Session Details

William Stevens
2017 (Liverpool) Annual Meeting

Contributed Session
Producing CDISC compliant data and metadata for regulatory submissions

Session Details

Clare Cruickshank
2017 (Liverpool) Annual Meeting

Contributed Session
Quality assurance (QA) challenges in the development of international trials in rare diseases.

Session Details

Noga Lewin
2017 (Liverpool) Annual Meeting

Contributed Session
Quality Control of SDTM Domain Mappings from Electronic Case Report Forms

Session Details

Joanne Rothwell
2017 (Liverpool) Annual Meeting

Contributed Session
Quantifying Effect Sizes in Clinical Trials

Session Details

Heather Catt
2017 (Liverpool) Annual Meeting

Contributed Session
Quantitative benefit-risk modelling of infliximab biosimilar Inflectra versus reference product Remicade in the treatment of Crohn’s disease

Session Details

Simon Bond
2017 (Liverpool) Annual Meeting

Contributed Session
R package to implement Rank Preserving Structural Failure Time Models

Session Details

Rebecca Randell
2017 (Liverpool) Annual Meeting

Contributed Session
Randomised Controlled Trials and Realist Evaluation: In What Contexts and How?

Session Details

Jeff Szychowski
2017 (Liverpool) Annual Meeting

Contributed Session
Randomization Balance in Multicenter Clinical Trials with Short Drug Life and Rapid Allocation

Session Details

Gene Pennello
2017 (Liverpool) Annual Meeting

Contributed Session
Randomized Trial Designs for Evaluating Predictive Markers: What is the Estimand?

Session Details

Lisa Woodhouse
2017 (Liverpool) Annual Meeting

Contributed Session
Rationale for using an ordinal primary outcome in clinical trials for the prevention of recurrent stroke and transient ischaemic attack

Session Details

Jane Daniels
2017 (Liverpool) Annual Meeting

Contributed Session
Reaching a consensus on causes of pain: use of an expert independent panel to determine a reference standard

Session Details

Qi Long
2017 (Liverpool) Annual Meeting

Session Proposal
Recent Advances in Methods for Handling Missing Data in Clinical Trials

Session Details

Karla Hemming
2017 (Liverpool) Annual Meeting

Session Proposal
Recent Developments in the Design and Analysis of Cluster Randomized Trials

Session Details

Suzanne Breeman
2017 (Liverpool) Annual Meeting

Contributed Session
Record Linkage of Trial Datasets to Hospital Admission Records: A Trial Manager’s Experience

Session Details

Steven Penegar
2017 (Liverpool) Annual Meeting

Contributed Session
Recruitment aids for a phase II randomised trial in low risk bladder cancer

Session Details

Claire Diver
2017 (Liverpool) Annual Meeting

Contributed Session
Recruitment and participation in the stem cell trial of recovery enhancement-3 (STEMS-3): experiences of stroke survivors and their carer’s.

Session Details

Stephen Walters
2017 (Liverpool) Annual Meeting

Contributed Session
Recruitment and retention of participants in randomised controlled trials: a review of trials funded by the United Kingdom Health Technology Assessment Programme

Session Details

Christy Toms
2017 (Liverpool) Annual Meeting

Contributed Session
Recruitment estimates provided by sites - are they consistent with observed accrual?

Session Details

Sarah Tearne
2017 (Liverpool) Annual Meeting

Contributed Session
Recruitment in GP practices: Research assistant or research nurse?

Session Details

Katie Flaherty
2017 (Liverpool) Annual Meeting

Contributed Session
Recruitment monitoring and predictions: data from the Tranexamic acid for IntraCerebral Haemorrhage (TICH-2) trial.

Session Details

Ceri Rowlands
2017 (Liverpool) Annual Meeting

Contributed Session
Recruitment to randomised controlled trials in patients receiving unplanned hospital care: a systematic review and in-depth analysis using the ORRCA database

Session Details

Anna Kearney
2017 (Liverpool) Annual Meeting

Contributed Session
Reducing attrition: The communication of retention and withdrawal within Patient Information Sheets

Session Details

Alexanda Wright-Hughes
2017 (Liverpool) Annual Meeting

Contributed Session
Reducing bias in randomised controlled trials involving therapists: To randomise or not to randomise – what are the questions?

Session Details

Jamilla Hussain
2017 (Liverpool) Annual Meeting

Contributed Session
Reducing missing data in palliative care randomised controlled trials: a mixed-methods study

Session Details

Jennifer Talton
2017 (Liverpool) Annual Meeting

Contributed Session
REDUCING UNDER- AND OVER-TRIAGE IN MOTOR VEHICLE CRASHES USING AN INJURY-BASED APPROACH

Session Details

Prof Marion Campbell
2017 (Liverpool) Annual Meeting

Session Proposal
REGISTRY-BASED RANDOMISED CONTROLLED TRIALS – THE FUTURE FOR CLINICAL TRIALS?

Session Details

Catherine Oldenburg
2017 (Liverpool) Annual Meeting

Contributed Session
Regression discontinuity for replication of randomized controlled trial results: An application to the Mycotic Ulcer Treatment Trials

Session Details

Sara Valencia
2017 (Liverpool) Annual Meeting

Contributed Session
Regulation in Latin America and its impact on the execution of multinational clinical trials to evaluate vaccines.

Session Details

Jane Blazeby
2017 (Liverpool) Annual Meeting

Contributed Session
REPORT-UK (Real-time Electronic Patient Outcome ReporTing of adverse events in UK cancer trials): Methods to optimise data collection

Session Details

Anna Kearney
2017 (Liverpool) Annual Meeting

Contributed Session
Reported reasons for missing data

Session Details

Marcus Johnson
2017 (Liverpool) Annual Meeting

Contributed Session
Research Site Mentoring: A Novel Approach to Improving Study Recruitment

Session Details

Alina Striha
2017 (Liverpool) Annual Meeting

Contributed Session
Response and Progression Endpoint Review in a Large Phase III Randomised Control Trial of Multiple Myeloma

Session Details

Katie Gillies
2017 (Liverpool) Annual Meeting

Contributed Session
Retention in randomised trials: What matters to Trial Managers?

Session Details

Cathryn Rankin
2017 (Liverpool) Annual Meeting

Contributed Session
Retrospective Preparation of Trial Results for Regulatory Submission: Challenges and Lessons Learned

Session Details

Nicola Totton
2017 (Liverpool) Annual Meeting

Contributed Session
Review of pilot and feasibility studies from a registry website; an overview of recent practice.

Session Details

Jody Ciolino
2017 (Liverpool) Annual Meeting

Contributed Session
Review of Treatment Allocation Schemes Reported in Published Clinical Trial Results

Session Details

Caroline Hurley
2017 (Liverpool) Annual Meeting

Contributed Session
RISK BASED MONITORING (RBM) TOOLS FOR CLINICAL TRIALS: A SYSTEMATIC REVIEW

Session Details

Vicky Tsipouri
2017 (Liverpool) Annual Meeting

Contributed Session
Rituximab versus cyclophosphamide for the treatment of connective tissue disease associated interstitial lung disease (RECITAL): a randomised controlled trial.

Session Details

Tianchen Qian
2017 (Liverpool) Annual Meeting

Contributed Session
Robust Methods for Improving Power in Group Sequential Randomized Trial Designs, by Leveraging Prognostic Baseline Variables and Short-term Outcomes

Session Details

Daniel Sabanes Bove
2017 (Liverpool) Annual Meeting

Contributed Session
Rolling dose escalation with overdose control: an efficient and safe phase 1 design

Session Details

James Moon
2017 (Liverpool) Annual Meeting

Contributed Session
S0819: Lessons Learned from Conduct of a Cooperative Group Phase III Trial with a Biomarker Defined Subset Co-Primary Objective.

Session Details

Dominic Stringer
2017 (Liverpool) Annual Meeting

Contributed Session
Sample size adaptations in a randomised controlled biomarker based strategy (hybrid) trial: Experience from the OuTSMART Trial.

Session Details

Andrew Forbes
2017 (Liverpool) Annual Meeting

Contributed Session
Sample size calculations for cluster randomised trials: Reconciling variance components in generalised linear mixed models with marginal intracluster correlations

Session Details

Duncan Wilson
2017 (Liverpool) Annual Meeting

Contributed Session
Sample size calculations using Bayesian optimisation

Session Details

Julie Wych
2017 (Liverpool) Annual Meeting

Contributed Session
Sample Size Re-estimation in Cross-over Trials: a Simulation Study Investigating the Type I Error, Power and Sample Size in the AIM HY-INFORM Study

Session Details

Kenneth Babigumira
2017 (Liverpool) Annual Meeting

Contributed Session
SCALING THE DRUG SUPPLY MANAGEMENT MOUNTAIN: A CASE STUDY OF THE ADD-ASPIRIN TRIAL

Session Details

Vivien Coates
2017 (Liverpool) Annual Meeting

Contributed Session
Scaling Up? Lessons from a feasibility study involving people with type 2 diabetes and their families

Session Details

Helen Myers
2017 (Liverpool) Annual Meeting

Contributed Session
Seeing the light at the end of the carpal tunnel: The challenges of recruiting sites to a Clinical Trial of an Investigational Medicinal Product in primary care.

Session Details

Monica Taljaard
2017 (Liverpool) Annual Meeting

Session Proposal
Selection biases in cluster randomised trials: how do identify, avoid and report

Session Details

Matthew Franklin
2017 (Liverpool) Annual Meeting

Contributed Session
Self-reported and electronic resource use for trial-based economic evaluations: the current state of play in England and considerations for the future

Session Details

Holly Tovey
2017 (Liverpool) Annual Meeting

Contributed Session
Sensitivity analysis assessing the impact of patient self-reported follow up in the REACT trial

Session Details

Suzie Cro
2017 (Liverpool) Annual Meeting

Contributed Session
Sensitivity analysis for missing data using the Delta method: the impact of incorporating a prior distribution on Delta

Session Details

Steff Lewis
2017 (Liverpool) Annual Meeting

Session Proposal
Sharing individual participant data from clinical trials: Current practice and future thinking

Session Details

Jamilla Hussain
2017 (Liverpool) Annual Meeting

Contributed Session
Should CONSORT do more to improve the quality of missing data reporting in trials?

Session Details

Zhibao Mi
2017 (Liverpool) Annual Meeting

Contributed Session
Simulation of Various Strategies for Optimal Selection of Randomization Methods in Multicenter Clinical Trials

Session Details

Giuseppe de Vito
2017 (Liverpool) Annual Meeting

Contributed Session
Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer: combining past and current evidence in a Bayesian reanalysis.

Session Details

Kerry Woolfall
2017 (Liverpool) Annual Meeting

Contributed Session
Site training to improve healthcare practitioners’ confidence in recruiting to a challenging critical care trial

Session Details

Clemence Leyrat
2017 (Liverpool) Annual Meeting

Contributed Session
Small sample corrections for cluster randomised trials: implications for power and type I error rate

Session Details

Vichithranie Madurasinghe
2017 (Liverpool) Annual Meeting

Contributed Session
Smoking treatment optimisation in pharmacies (STOP): cluster randomised pilot trial of a training intervention

Session Details

Joy Black
2017 (Liverpool) Annual Meeting

Contributed Session
Splintered Adverse Event Reporting in Multicenter Clinical Trials

Session Details

Beatriz Goulao
2017 (Liverpool) Annual Meeting

Contributed Session
Split-plot designs: sample size considerations

Session Details

David White
2017 (Liverpool) Annual Meeting

Contributed Session
Staff experiences of closing out a clinical trial involving withdrawal of treatment: qualitative study

Session Details

Guy Peryer
2017 (Liverpool) Annual Meeting

Contributed Session
Standard operating procedures for managing adverse events in trials that do not involve an investigational medicinal product: a protocol for a Delphi consensus study

Session Details

Alice Tsai
2017 (Liverpool) Annual Meeting

Contributed Session
STANDARDISATION AND COMPETENCY ASSESSMENT OF TRANSANAL TOTAL MESORECTAL EXCISION (TATME) FOR RECTAL CANCERS: SURGICAL QUALITY ASSURANCE IN THE CONTEXT OF A RANDOMISED CONTROLLED TRIAL

Session Details

Susanna Dodd
2017 (Liverpool) Annual Meeting

Contributed Session
Standardised taxonomy for the classification of trial outcomes within core outcome sets and Cochrane Reviews

Session Details

Cliona McDowell
2017 (Liverpool) Annual Meeting

Contributed Session
Statistical Analysis Plans for Internal Pilots in Randomised Controlled Trials

Session Details

Amylou Dueck
2017 (Liverpool) Annual Meeting

Contributed Session
Statistical analysis strategies for PRO-CTCAE data in oncology clinical trials: a simulation study

Session Details

David Gillespie
2017 (Liverpool) Annual Meeting

Contributed Session
Statistical and Practical Considerations when Measuring Adherence to Medication in Clinical Trials: Estimation of Agreement, Prediction of Disagreement, and Derivation of Calibrated Measures

Session Details

Theodore Karrison
2017 (Liverpool) Annual Meeting

Session Proposal
Statistical and Practical Considerations When Terminating a Trial Early: Contrasting early stopping due to harm (ACCORD) versus for benefit (SPRINT).

Session Details

Shun Fu Lee
2017 (Liverpool) Annual Meeting

Contributed Session
Statistical considerations for analyzing multiplex biomarker data from prospective studies.

Session Details

Lee Middleton
2017 (Liverpool) Annual Meeting

Contributed Session
Statistical issues in data monitoring of clinical trials that incorporate assessment of pregnancy loss

Session Details

Mohamed Mubasher
2017 (Liverpool) Annual Meeting

Contributed Session
Stopping Rules for Long Term Clinical Trials Based on Two Consecutive Rejections of the Null Hypothesis

Session Details

Heidi Gardner
2017 (Liverpool) Annual Meeting

Contributed Session
Strategies to improve participant recruitment to randomised controlled trials: A systematic review of non-randomised evaluations

Session Details

Eleanor Mitchell
2017 (Liverpool) Annual Meeting

Contributed Session
Streamlining SAE handling in a busy CTU

Session Details

Colin Everett
2017 (Liverpool) Annual Meeting

Contributed Session
Structured Statistical Analysis Plans for improved clarity of intended analysis

Session Details

Barnaby Reeves
2017 (Liverpool) Annual Meeting

Contributed Session
Success of randomizing trial participants to disclosure of allocation early or late: a methodological study to investigate performance bias

Session Details

Amy Rogers
2017 (Liverpool) Annual Meeting

Contributed Session
Successful Recruitment to a Large Online Randomised Trial: The TIME study

Session Details

Jared Foster
2017 (Liverpool) Annual Meeting

Contributed Session
Surrogate Endpoint Evaluation in a Personalized Medicine Framework

Session Details

Eileen Stock
2017 (Liverpool) Annual Meeting

Contributed Session
Surveillance of Clinical Trial Performance using Centralized Statistical Monitoring

Session Details

Kathryn Monson
2017 (Liverpool) Annual Meeting

Contributed Session
Surveying patients’ views on trial information provision and decision making using the ‘Accept/Decline’ clinical trials questionnaire

Session Details

Jieling Miao
2017 (Liverpool) Annual Meeting

Contributed Session
SWOG S1700: An institutional cluster-randomized trial of a surgical lymph node specimen collection kit in the Cooperative Group Setting

Session Details

Ikhlaaq Ahmed
2017 (Liverpool) Annual Meeting

Contributed Session
Synchronous Chemo-Radiation Can Reduce Local and Loco-regional Recurrence In Early Stage Breast Cancer: Results of a randomised controlled trial SECRAB

Session Details

Gordon Forbes
2017 (Liverpool) Annual Meeting

Contributed Session
Systematic review of the use of mediation analysis in randomised controlled trials in the primary healthcare setting

Session Details

Lauren Yesko
2017 (Liverpool) Annual Meeting

Contributed Session
Tailoring a Comprehensive Website to Support a Clinical Research Network

Session Details

Allan Walker
2017 (Liverpool) Annual Meeting

Contributed Session
Taking the REDCap data management tool to the next step. Reducing complexity in study design by smoother integration of external randomisation services thus providing a more streamlined experience for users

Session Details

Fang Chen
2017 (Liverpool) Annual Meeting

Contributed Session
Telephone support for mail based recruitment and follow-up in a large randomized trial

Session Details

Dionne Russell
2017 (Liverpool) Annual Meeting

Contributed Session
The advantages of simple analytics in ePRO environments

Session Details

Dr Hemming
2017 (Liverpool) Annual Meeting

Contributed Session
The assumption of common secular trends across clusters in a stepped-wedge cluster randomised trial: does it matter?

Session Details

Gavin Reilly
2017 (Liverpool) Annual Meeting

Contributed Session
The changing world of clinical trials 2003 – 2017: A view from the AspECT trial

Session Details

Sarah Gaussoin
2017 (Liverpool) Annual Meeting

Contributed Session
The Cocoa Supplement and Multivitamin Outcomes Study in the Mind (COSMOS-MIND): Design and Rationale

Session Details

David Reeves
2017 (Liverpool) Annual Meeting

Contributed Session
The Cohort Multiple Randomised Controlled Trial: methodological lessons from a practical application (the PROTECTS trial)

Session Details

minjin kang
2017 (Liverpool) Annual Meeting

Contributed Session
The comparison of results from Nested case-control and Nested cohort design in Big Data

Session Details

Scott Rushing
2017 (Liverpool) Annual Meeting

Contributed Session
The COMPASS Study - Dynamic Generation of Patient-specific eCare Plans in a Pragmatic Trial

Session Details

Paul Silcocks
2017 (Liverpool) Annual Meeting

Contributed Session
The design and analysis of early phase II trials with naturally bounded continuous fractional outcomes

Session Details

Kirsty Cockle
2017 (Liverpool) Annual Meeting

Contributed Session
The EAGLE Study: Improving the Wellbeing of Men by Evaluating and Addressing the Gastrointestinal Late Effects of Radical Treatment for Prostate Cancer

Session Details

Alison Pullan
2017 (Liverpool) Annual Meeting

Contributed Session
The effect of small or unbalanced clusters of patients on logistic regression models in surgical trials

Session Details

Simon Bacon
2017 (Liverpool) Annual Meeting

Contributed Session
The Effect of the Non-Pharmacological Extension of CONSORT in Quality of Reporting of Behavioural weight loss RCTs

Session Details

Jonathan Gibb
2017 (Liverpool) Annual Meeting

Contributed Session
The evil of eval() in CTMS - How to get more from user defined code

Session Details

Andisheh Bakhshi
2017 (Liverpool) Annual Meeting

Contributed Session
The Glasgow ‘Deep End’ Links Worker Programme Evaluation: Analysis Implication of an Unusual Randomised Study Design

Session Details

Christopher Partlett
2017 (Liverpool) Annual Meeting

Contributed Session
The impact of blinded endpoint review on the incidence of primary short-term outcomes in the SIFT trial

Session Details

Kaleab Abebe
2017 (Liverpool) Annual Meeting

Contributed Session
The Impact of Sample Size Re-estimation using Baseline ICC in Cluster Randomized Trials: 3 Case Studies

Session Details

Karen Innes
2017 (Liverpool) Annual Meeting

Contributed Session
The importance of informational items in a Randomised Controlled Trial Participant Information Leaflet: A mixed method study

Session Details

Ian Thomas
2017 (Liverpool) Annual Meeting

Contributed Session
The importance of randomisation in evaluation of treatments for Acute Myeloid Leukaemia: Lessons from the UK NCRI AML16 and LI-1 trials

Session Details

Laura Howells
2017 (Liverpool) Annual Meeting

Contributed Session
The minimum clinically important difference (MCID) of the Patient Oriented Eczema Measure (POEM): do different methods of calculation give different MCIDs?

Session Details

Jody Ciolino
2017 (Liverpool) Annual Meeting

Contributed Session
The Mothers and Babies Cluster-Randomized Trial: A Complex Case of Constrained Randomization

Session Details

Julia Robertson
2017 (Liverpool) Annual Meeting

Contributed Session
The Paperless Paradigm: Transitioning to Direct Participant Data Entry in the SEARCH for Diabetes in Youth Study

Session Details

Robert Hills
2017 (Liverpool) Annual Meeting

Contributed Session
The Patient Journey Planner: An integrated approach to trials of targeted therapies with application to cancer and haematological malignancies

Session Details

Steven A. Julious
2017 (Liverpool) Annual Meeting

Session Proposal
The PLEASANT Trial – practical experiences and lessons for a primary care cluster randomised trial looking to prevent the peak in asthma after the return to school analysed using routine data

Session Details

Nicky Welton
2017 (Liverpool) Annual Meeting

Contributed Session
The potential benefit of an RCT comparing wound dressings in general surgery (the Bluebelle study): a Value of Information analysis and comparison with standard sample size calculations

Session Details

Sandra Eldridge
2017 (Liverpool) Annual Meeting

Session Proposal
The Pragmatic Randomized Controlled Trial at 50: Past Successes; Future Challenges

Session Details

Sue Bell
2017 (Liverpool) Annual Meeting

Contributed Session
The pros and cons of an ‘umbrella’ trial design for a rare disease from a trial management and data management perspective

Session Details

Claire Chan
2017 (Liverpool) Annual Meeting

Contributed Session
The Quality of Reporting of Pilot and Feasibility Cluster Randomised Trials: A Systematic Review

Session Details

Helen Myers
2017 (Liverpool) Annual Meeting

Contributed Session
The role and impact of patient and public involvement and engagement (PPIE) in clinical research: perspectives from Keele CTU Project Management.

Session Details

Lee Beresford
2017 (Liverpool) Annual Meeting

Contributed Session
The SALVO Study: A Retrospective Take on an Interim Analysis of Futility in a Randomised Trial

Session Details

Aiden Doherty on behalf of the Clinical Trials Transformation Initiative Mobile Clinical Trials Program
2017 (Liverpool) Annual Meeting

Session Proposal
The Scientific and Technological Issues Surrounding the use of Mobile Devices in Clinical Trials: A Clinical Trials Transformation Initiative (CTTI) Project

Session Details

Tracee Williams
2017 (Liverpool) Annual Meeting

Contributed Session
The Training Documentation Form – Going Beyond the Basics for the National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN)

Session Details

Matthew Parkes
2017 (Liverpool) Annual Meeting

Contributed Session
The Two-Stage Treatment Selection (TSTS) Design: A Novel Approach to Treatment Selection in Clinical Trials

Session Details

Judith Bliss
2017 (Liverpool) Annual Meeting

Contributed Session
The UK plasma based Molecular profiling of Advanced breast cancer to inform Therapeutic CHoices (plasmaMATCH) Trial: A multiple parallel cohort, open-label, multi-centre phase IIa clinical trial aiming to provide proof of principle efficacy for designated targeted therapies in patients with advanced breast cancer where the targetable mutation is identified through ctDNA screening (CRUK/15/010)

Session Details

Sharon Kean
2017 (Liverpool) Annual Meeting

Contributed Session
The UKCRC Information Systems Operational Group: What is it we do?

Session Details

Caroline Kristunas
2017 (Liverpool) Annual Meeting

Contributed Session
The use of feasibility studies for stepped-wedge cluster randomised trials: a review of impact and scope.

Session Details

Reuben Ogollah
2017 (Liverpool) Annual Meeting

Contributed Session
The use of regular text messaging over one year to collect primary outcome data in a randomised controlled trial

Session Details

Richard Jackson
2017 (Liverpool) Annual Meeting

Contributed Session
The use of unequal allocation ratios in the design of randomised Phase II trials

Session Details

Francesca Schiavone
2017 (Liverpool) Annual Meeting

Contributed Session
This is a platform alteration: A Trial Management Perspective on the operational aspects of adaptive platform trials

Session Details

David Pickles
2017 (Liverpool) Annual Meeting

Contributed Session
Time well spent? A comparison of the work associated with collecting primary and secondary outcomes

Session Details

Jayne Tierney
2017 (Liverpool) Annual Meeting

Contributed Session
Timely and reliable evaluation of the effects of interventions: a Framework for Adaptive Meta-analysis (FAME)

Session Details

Jules Hernandez-Sanchez
2017 (Liverpool) Annual Meeting

Contributed Session
Tocilizumab in pulmonary hypertension

Session Details

Jenna Gabrio
2017 (Liverpool) Annual Meeting

Contributed Session
Tools and Processes for Tracking IRB Approvals as a DCC for Large Multi-Center Clinical Research Networks

Session Details

Michael Ham
2017 (Liverpool) Annual Meeting

Contributed Session
TRACKING DATA REQUESTS FROM INITIATION TO PUBLICATION THROUGH THE USE OF A WEB-ENABLED DATABASE SYSTEM.

Session Details

Abigail Shoben
2017 (Liverpool) Annual Meeting

Contributed Session
Tradeoffs of a randomize, then consent approach to improving cluster participation rates in cluster randomize trials

Session Details

Natalie Ives
2017 (Liverpool) Annual Meeting

Contributed Session
Training the Clinical Investigators of the Future – A Clinical Trials Clerkship

Session Details

Jye-Yu Backlund
2017 (Liverpool) Annual Meeting

Contributed Session
Transition from Paper to Digital Electrocardiograms (ECGs) after 30 Years of Follow-up in the DCCT/EDIC Study

Session Details

Courtney Nelson
2017 (Liverpool) Annual Meeting

Contributed Session
Translation of a single-center cellular therapy manufacturing approach to a multi-center, center-specific manufacturing platform: the experience of the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) Protocol #1401.

Session Details

Lucy Beasant
2017 (Liverpool) Annual Meeting

Contributed Session
Treatment preference and recruitment to a paediatric randomised controlled trial: Managed Activity Graded Exercise iN Teenagers and pre-Adolescents (MAGENTA).

Session Details

Victoria Goodwin
2017 (Liverpool) Annual Meeting

Contributed Session
Treatment success in randomised controlled trials of rehabilitation: a review

Session Details

Susan Halabi
2017 (Liverpool) Annual Meeting

Contributed Session
Two New Residuals In Survival Analysis With Full Likelihood

Session Details

Dr. Richéal Burns
2017 (Liverpool) Annual Meeting

Educational Session
Understanding and interpreting health economic evaluation alongside clinical trials.

Session Details

Professor Richard Emsley
2017 (Liverpool) Annual Meeting

Educational Session
Understanding how treatments work: Evaluating treatment mechanisms in randomised trials

Session Details

Zoe Tolkien
2017 (Liverpool) Annual Meeting

Contributed Session
Understanding methods for the assessment of patient adherence: a case study in removable devices for the improvement of trial outcome data.

Session Details

Karla DiazOrdaz
2017 (Liverpool) Annual Meeting

Contributed Session
Understanding, quantifying and reducing recruitment bias in cluster randomized trials

Session Details

Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine
2017 (Liverpool) Annual Meeting

Educational Session
Understanding, reporting and conducting pilot and feasibility trials

Session Details

Assaf Oron
2017 (Liverpool) Annual Meeting

Contributed Session
Up-and-Down Designs Enhanced with SPRT Rules for Phase I Cancer Trials

Session Details

Assaf P. Oron
2017 (Liverpool) Annual Meeting

Educational Session
Up-and-Down: The Forgotten Alternative for Phase I Trials

Session Details

Barbara Braffett
2017 (Liverpool) Annual Meeting

Contributed Session
Use of a Non-Diabetic Spouse Control Group in the DCCT/EDIC Hearing Study

Session Details

Leona Batten
2017 (Liverpool) Annual Meeting

Contributed Session
Use of data review software for data management

Session Details

Katie Pike
2017 (Liverpool) Annual Meeting

Contributed Session
Use of instrumental variables within randomised controlled trials

Session Details

Francesca Fiorentino
2017 (Liverpool) Annual Meeting

Contributed Session
Use of longitudinal data in the analysis of biomarkers: lessons from simulation and reality.

Session Details

Elaine Pascoe
2017 (Liverpool) Annual Meeting

Contributed Session
Use of minimization in multi-center clinical trials - when to not add randomization

Session Details

Clare Thomas
2017 (Liverpool) Annual Meeting

Contributed Session
Use of primary care electronic records to monitor and improve intervention delivery of a GP practice level intervention.

Session Details

Olympia Papachristofi
2017 (Liverpool) Annual Meeting

Contributed Session
Use of routine databases to aid the design of multicentre surgical trials with length-of-stay as the primary outcome.

Session Details

Nuria Porta
2017 (Liverpool) Annual Meeting

Contributed Session
Use of simulations to explore recruitment and the impact of late availability of experimental arms in the PIVOTALboost trial

Session Details

Torsak Bunupuradah
2017 (Liverpool) Annual Meeting

Contributed Session
Usefulness of in-house electronic health record and task-shifting in a pediatric HIV cohort, Bangkok, Thailand

Session Details

Royes Joseph
2017 (Liverpool) Annual Meeting

Contributed Session
Using “off-treatment” data to estimate the de facto estimand in a randomised trial

Session Details

Daniel Hind
2017 (Liverpool) Annual Meeting

Contributed Session
Using a logic model and a triangulation protocol for integrating quantitative and qualitative research data in a mixed-methods feasibility study incorporating an external pilot RCT

Session Details

Stephanie DuBose
2017 (Liverpool) Annual Meeting

Contributed Session
USING A PATIENT REGISTRY TO CONDUCT NON-CLINIC ENGAGED STUDIES

Session Details

Elizabeth Turner
2017 (Liverpool) Annual Meeting

Contributed Session
Using causal diagrams to guide analyses of randomized controlled trials with missing outcomes

Session Details

Erik Doffagne
2017 (Liverpool) Annual Meeting

Contributed Session
Using Central Statistical Monitoring to Drive Quality into Clinical Trials

Session Details

Michelle Nunn
2017 (Liverpool) Annual Meeting

Contributed Session
Using dedicated study laptops to enhance data quality, participant safety, and trial efficiency: Experience from a large-scale, international, randomized clinical trial

Session Details

Suzanne Hartley
2017 (Liverpool) Annual Meeting

Contributed Session
Using electronic health records in clinical trials: rising to the challenge of developing a data linkage pipeline – experience from the ISCOMAT programme.

Session Details

Maimoona Hashmi
2017 (Liverpool) Annual Meeting

Contributed Session
Using Electronic Healthcare Records (EHR) to screen, locate and recruit participants from primary care.

Session Details

Saams Joy
2017 (Liverpool) Annual Meeting

Contributed Session
Using Graphical Displays to Monitor Start-up and Recruitment in Clinical Trials

Session Details

Mirella Longo
2017 (Liverpool) Annual Meeting

Contributed Session
Using multiple qualitative methods to develop a complex intervention: the PACT study

Session Details

Aleksandra Murawska
2017 (Liverpool) Annual Meeting

Contributed Session
Using Optical Character Recognition for processing paper forms in a large randomised clinical trial

Session Details

Scott Evans
2017 (Liverpool) Annual Meeting

Contributed Session
Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: Partial Credit, Pragmatism, and Benefit:Risk Evaluation

Session Details

William Stevens
2017 (Liverpool) Annual Meeting

Contributed Session
Using OWL to classify adverse events

Session Details

Karen Bracken
2017 (Liverpool) Annual Meeting

Contributed Session
Using phone, SMS and email screening reminders to improve clinical trial recruitment: results from a sub-study of the T4DM Diabetes Prevention Study

Session Details

Julie Bruce
2017 (Liverpool) Annual Meeting

Contributed Session
Using photographic images to aid wound assessment within a randomised controlled trial of standard wound management versus negative pressure wound therapy: UK WOLLF Trial.

Session Details

Matthew Nankivell
2017 (Liverpool) Annual Meeting

Contributed Session
Using proxy responses from carers to collect quality of life data on patients with brain metastases: An analysis from the UK MRC QUARTZ trial.

Session Details

Daniel Sabanés Bové
2017 (Liverpool) Annual Meeting

Educational Session
Using R for Early-Phase Dose Finding Studies

Session Details

Brennan Kahan
2017 (Liverpool) Annual Meeting

Contributed Session
Using re-randomisation in clinical trials to increase patient recruitment

Session Details

Jody D Ciolino
2017 (Liverpool) Annual Meeting

Educational Session
Using REDCap for Data Capture in Clinical Trials: Database Management on a Budget

Session Details

Jennifer Talton
2017 (Liverpool) Annual Meeting

Contributed Session
Using REDCap’s Piping Feature to Aid in Longitudinal Data Collection

Session Details

Graham Powell
2017 (Liverpool) Annual Meeting

Contributed Session
Using Routinely Recorded Data in a Clinical Trial: The Feasibility, Agreement and Additional Benefits Compared to Standard Prospective Data Collection Methods

Session Details

James Glasbey
2017 (Liverpool) Annual Meeting

Contributed Session
Using trainee-led, collaborative research to generate hypotheses for multi-centre clinical trials

Session Details

Ashley Hogan
2017 (Liverpool) Annual Meeting

Contributed Session
Utilizing Remote Participant Visits to Boost Retention in a Long-Term Clinical Trial

Session Details

Janet Dunn
2017 (Liverpool) Annual Meeting

Contributed Session
Value of a sister observational cohort alongside a randomised controlled trial with an internal feasibility phase

Session Details

Anna Heath
2017 (Liverpool) Annual Meeting

Contributed Session
Value of Sample Information as a tool in Clinical Trial Design

Session Details

Leslie Carroll
2017 (Liverpool) Annual Meeting

Contributed Session
Value-Added Use of Clinical Study Data: A BioLINCC Perspective on Creating Well-Annotated Data Packages for the Wider Scientific Community

Session Details

Nicola Lawrence
2017 (Liverpool) Annual Meeting

Contributed Session
Valuing the effect sizes hypothesized in phase 3 trials of targeted therapies in oncology

Session Details

Erin Bengelink
2017 (Liverpool) Annual Meeting

Contributed Session
Variability in Adverse Event Reporting Rates per Subject by Enrollment Site in a Multicenter Acute Care Clinical Trial

Session Details

Rachel Maishman
2017 (Liverpool) Annual Meeting

Contributed Session
Variability in composite outcomes reported in cardiac surgery studies: a literature review

Session Details

Martin Adamcik
2017 (Liverpool) Annual Meeting

Contributed Session
Venous Thromboembolism and Cancer Trials Evidence Synthesis: Dealing with both Complex Knowledge and Unexplained Heterogeneity

Session Details

Claudia Oblasser
2017 (Liverpool) Annual Meeting

Contributed Session
Vibrating vaginal balls to improve pelvic floor muscle performance in women after childbirth: a randomised controlled feasibility trial

Session Details

Trish Hepburn
2017 (Liverpool) Annual Meeting

Contributed Session
Waiting list control designs in trials of non-pharmacological interventions for eczema

Session Details

Lesley Dunleavy
2017 (Liverpool) Annual Meeting

Contributed Session
What are the barriers and facilitators to patient and carer recruitment to randomised controlled trials in palliative care? A systematic review with narrative synthesis.

Session Details

Loretta Davies
2017 (Liverpool) Annual Meeting

Contributed Session
What are the methodological challenges in the design and conduct of orthopaedic randomised controlled trials comparing surgery and non-operative interventions? A systematic review

Session Details

Colin Everett
2017 (Liverpool) Annual Meeting

Contributed Session
What barriers exist to statisticians recommending alternative methods to Permuted Block randomisation?

Session Details

Carol Bugge
2017 (Liverpool) Annual Meeting

Contributed Session
What does qualitative case study methodology have to offer the interpretation of findings from trials of complex interventions? Reflections from a large complex intervention study.

Session Details

Anna Rosala-Hallas
2017 (Liverpool) Annual Meeting

Contributed Session
What might a Global Health Trials Methodology Research Agenda look like?

Session Details

Jamie Brehaut
2017 (Liverpool) Annual Meeting

Contributed Session
When Can Hypothetical Pilot Data Predict Real-World Trial Results? A Systematic Concept Review and Framework.

Session Details

Anne Duncan
2017 (Liverpool) Annual Meeting

Contributed Session
When is enough, enough? Replication of behaviour change interventions to minimise attrition of follow up questionnaires

Session Details

Lauren Bell
2017 (Liverpool) Annual Meeting

Contributed Session
When is the best time to internally assess recruitment in a Cluster Randomised Controlled Trial?

Session Details

Seonaidh Cotton
2017 (Liverpool) Annual Meeting

Contributed Session
Why do trials get suspended? A review of data from ClinicalTrials.gov and ISRCTN

Session Details

Karl Wallendszus
2017 (Liverpool) Annual Meeting

Contributed Session
Why use CDISC for trials not submitted to regulators? Lessons from the experience of an academic clinical trial unit

Session Details

Claire Snowdon
2017 (Liverpool) Annual Meeting

Contributed Session
Working with a vulnerable population on a sensitive topic to better understand neonatal intensive care trials: development of a suite of strategies to meet challenges for qualitative data collection in the BRACELET Study

Session Details

Junhua Zhang
2017 (Liverpool) Annual Meeting

Session Proposal
Workshop for Chinese Medicine Clinical Trials

Session Details

Richard Stephens
2016 (Montreal) Annual Meeting

Founders Lecture
Patients as Partners in Cancer Research

LEAP Trial team
2016 (Montreal) Annual Meeting

Trial of the Year Award
Learning Early About Peanut Allergy (LEAP)

Wendy Parulekar
2016 (Montreal) Annual Meeting

Presidential Welcome

Denis Lacombe
2016 (Montreal) Annual Meeting

Curtis Meinert Lecture
EOTRC (European Organisation for Research and Treatment of Cancer)

Mark Espeland
2016 (Montreal) Annual Meeting

Fellows Presentation
Presentation of the Class of 2016 Fellows

Professor Paula Williamson
2016 (Montreal) Annual Meeting

Session Proposal
"Improving health by improving trials" – the UK Medical Research Council (MRC) Hubs for Trials Methodology Research (HTMR): a nation-wide network to develop capacity and optimise trial design and conduct

Session Details

Professor Barney Reeves
2016 (Montreal) Annual Meeting

Session Proposal
“It’s always too early until suddenly it’s too late”: designing surgical RCTs relevant to patients, staff and changing technologies

Session Details

Haitao Pan
2016 (Montreal) Annual Meeting

Contributed Session
A Bayesian Adaptive Group Sequential Design for Biosimilars with Historical Data

Session Details

Catherine Oldenburg
2016 (Montreal) Annual Meeting

Contributed Session
A CASE FOR CACE: THE COMPLIER AVERAGE CAUSAL EFFECT IN RANDOMIZED CONTROLLED TRIALS

Session Details

Michael Palmer
2016 (Montreal) Annual Meeting

Contributed Session
A Classification Framework For Root Causes Of Missing Data With Patient Reported Outcomes In Prospective Studies

Session Details

Geetha Beauchamp
2016 (Montreal) Annual Meeting

Contributed Session
A CLUSTER RANDOMIZED ANALYSIS OF SITE-LEVEL HIV SURVEILLANCE DATA IN HPTN 065 (TLC-PLUS) STUDY

Session Details

Paula Darby Lipman
2016 (Montreal) Annual Meeting

Contributed Session
A COLLABORATIVE STRATEGY TO CONDUCT AND LEARN FROM HIGH IMPACT PRAGMATIC TRIALS

Session Details

Nathaniel O'Connell
2016 (Montreal) Annual Meeting

Contributed Session
A latent variable approach to elicit continuous toxicity scores and severity weights for multiple toxicities in cancer clinical trials

Session Details

Mohamed-Amine Bayar
2016 (Montreal) Annual Meeting

Contributed Session
A long-term horizon simulation study to guide time-to-event RCTs with interim analyses in rare diseases

Session Details

Eric Tustison
2016 (Montreal) Annual Meeting

Contributed Session
A Nested Query Method for Efficient Enforcement of Timely Data Entry for Scheduled Outcomes

Session Details

Laura Collett
2016 (Montreal) Annual Meeting

Contributed Session
A NOVEL METHOD FOR ADJUSTING SURVIVAL ANALYSES TO REMOVE THE CONFOUNDING EFFECTS OF SUBSEQUENT THERAPY (CASCADE)

Session Details

David M. Murray
2016 (Montreal) Annual Meeting

Session Proposal
A practical overview of missing data issues in cluster-randomized designs for pragmatic trials

Session Details

Martin Tickle
2016 (Montreal) Annual Meeting

Contributed Session
A randomised control trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services (Northern Ireland Caries Prevention In Practice Trial - NIC-PIP trial)

Session Details

Alan Girling
2016 (Montreal) Annual Meeting

Contributed Session
A restricted randomisation scheme for stepped-wedge studies with a cluster-level covariate

Session Details

Cole Wayant
2016 (Montreal) Annual Meeting

Contributed Session
A review of outcomes presented in published and unpublished studies of pediatric acute lymphoblastic leukemia: Toward the development of a core outcome set.

Session Details

Yaoyao Xu
2016 (Montreal) Annual Meeting

Contributed Session
A Seamless Phase 2/3 Design Based on Continuous Outcome

Session Details

Soe Soe Thwin
2016 (Montreal) Annual Meeting

Contributed Session
A simple approach to assess enrollment prediction in clinical trials

Session Details

Allan Walker
2016 (Montreal) Annual Meeting

Contributed Session
A smarter stock re-supply mechanism for multi-centre drug trials where participants are prescribed drugs at multiple visits - an example from the MS-SMART trial

Session Details

Matthew Sims
2016 (Montreal) Annual Meeting

Contributed Session
A SYTEMATIC REVIEW OF CORE DOMAIN AND OUTCOME MEASUREMENT FOR SHOULDER ARTHROPLASTY TRIALS

Session Details

Kevin Wilson
2016 (Montreal) Annual Meeting

Contributed Session
A Tool to Generate and Validate Permuted-Block Randomization Tables

Session Details

Graham Wheeler
2016 (Montreal) Annual Meeting

Contributed Session
A toxicity-dependent feasibility bound for the Escalation with Overdose Control approach in phase I cancer trials

Session Details

Meghan Engbretson
2016 (Montreal) Annual Meeting

Contributed Session
ACADEMIC COOPERATIVE GROUP IMPLEMENTATION OF THE INITIATIVE TO STREAMLINE CLINICAL TRIALS

Session Details

Ileana Baldi
2016 (Montreal) Annual Meeting

Contributed Session
Accrual monitoring in cardiology research

Session Details

Neil Corrigan
2016 (Montreal) Annual Meeting

Contributed Session
Adjusting for learning effects in a surgical RCT

Session Details

DONALD TAVES
2016 (Montreal) Annual Meeting

Contributed Session
Advances in the Minimization vs. Randomization Debate

Session Details

Avie-Lee Tillotson
2016 (Montreal) Annual Meeting

Contributed Session
Adverse event coding in early phase trials

Session Details

Yiyi Chen
2016 (Montreal) Annual Meeting

Contributed Session
An Adaptive Bayesian Sequential Design Implemented Through an Interactive Software for Onsite Treatment Assignment

Session Details

Gennaro De Crescenzo
2016 (Montreal) Annual Meeting

Contributed Session
An efficient and economic solution for a clinical trial - Registry-based Randomized Clinical Trial (RRCT)

Session Details

Austin Horn
2016 (Montreal) Annual Meeting

Contributed Session
An ethical analysis of the SUPPORT study: Addressing challenges posed by a randomized controlled trial comparing standard treatments used in medical practice.

Session Details

Rebecca Simpson
2016 (Montreal) Annual Meeting

Contributed Session
AN INVESTIGATION OF THE FACTORS WHICH INFLUENCE CHILDREN WITH ASTHMA HAVING UNSCHEDULED MEDICAL CONTACTS AROUND THE START OF THE NEW SCHOOL YEAR IN ENGLAND AND WALES

Session Details

Corrado Lanera
2016 (Montreal) Annual Meeting

Contributed Session
ANALYSIS OF FREE TEXT ON ELECTRONIC MEDICAL REPORTS USING SEMI-SUPERVISED MACHINE LEARNING TECHNIQUES: A COMPARATIVE CASE-STUDY ON VARICELLA

Session Details

Karla Hemming
2016 (Montreal) Annual Meeting

Contributed Session
ANALYSIS OF THE CROSS-SECTIOTIONAL STEPPED WEDGE CLUSTER RANDOMSIED TRIAL

Session Details

Brittney Bailey
2016 (Montreal) Annual Meeting

Contributed Session
Analyzing Binary Outcome Data from an Individually Randomized Group Treatment Trial

Session Details

Samantha Hinsley
2016 (Montreal) Annual Meeting

Contributed Session
APPLICATION OF A BAYESIAN APPROACH TO TREATMENT SELECTION IN A RARE DISEASE SUB-POPULATION

Session Details

James Rochon
2016 (Montreal) Annual Meeting

Contributed Session
APPLICATION OF THE MARGINAL STRUCTURAL MODEL TO ACCOUNT FOR SUBOPTIMAL ADHERENCE IN A RANDOMIZED CONTROLLED TRIAL

Session Details

Gillian Gresham
2016 (Montreal) Annual Meeting

Contributed Session
Applications of wearable activity monitors in randomized clinical trials (RCT) in chronic disease populations: A review of the literature

Session Details

Ines Rombach
2016 (Montreal) Annual Meeting

Contributed Session
APPLYING MULTIPLE IMPUTATION TO MULTI-ITEM PATIENT REPORTED OUTCOME MEASURES: ADVANTAGES AND DISADVANTAGES OF IMPUTING AT THE ITEM, SUB-SCALE OR SCORE LEVEL

Session Details

Raymond Kraker
2016 (Montreal) Annual Meeting

Contributed Session
ARE LESS ACTIVE SITES MORE LIKELY TO DEVIATE FROM STUDY PROTOCOL AND PROCEDURES?

Session Details

Susan Halabi
2016 (Montreal) Annual Meeting

Contributed Session
Are Prognostic Models Valuable Tools in Guiding Treatment Decisions?

Session Details

Susan Halabi
2016 (Montreal) Annual Meeting

Session Proposal
Are Prognostic Models Valuable Tools in Guiding Treatment Decisions?

Session Details

Joanna Crocker
2016 (Montreal) Annual Meeting

Contributed Session
Assessing the impact of patient and public involvement on enrolment and retention in clinical trials: a systematic review

Session Details

Wenle Zhao
2016 (Montreal) Annual Meeting

Contributed Session
ASYMPTOTIC MAXIMAL PROCEDURE FOR SUBJECT RANDOMIZATION

Session Details

Sam T Mathew
2016 (Montreal) Annual Meeting

Session Proposal
Authorship of clinical trial publications. Is there a way to quantify the involvement and provide appropriate credit to the contributors?

Session Details

Hope Bryan
2016 (Montreal) Annual Meeting

Contributed Session
AUTOMATING THE EVENT REVIEW AND ADJUDICATION PROCESS FOR LARGE LONGITUDINAL STUDIES

Session Details

Robert Lew
2016 (Montreal) Annual Meeting

Contributed Session
Balancing site characteristics for stepped wedge designs

Session Details

Catherine Lowe
2016 (Montreal) Annual Meeting

Contributed Session
BEYOND THE PARTICIPANT INFORMATION SHEET: UTILISING PATIENT AND PUBLIC INVOLVEMENT TO IMPROVE PARTICIPANT INFORMATION

Session Details

Sabine Landau
2016 (Montreal) Annual Meeting

Contributed Session
Beyond total treatment effects in RCTs: Baseline measurement of intermediate outcomes needed to avoid confounding in mediation investigations

Session Details

Aurore Giljean
2016 (Montreal) Annual Meeting

Contributed Session
BIOMEDE Trial: a European randomized Phase 2 trial based on biomarkers evaluating new drugs in Diffuse Intrinsic Pontine Glioma (DIPG).

Session Details

Nicola Soriani
2016 (Montreal) Annual Meeting

Contributed Session
BIOSTAPP: AN INTEGRATED REPORTING AND MONITORING SYSTEM FOR CLINICAL STUDIES USING OPEN SOURCE SYSTEM

Session Details

Robert Califf
2016 (Montreal) Annual Meeting

Session Proposal
Building the Clinical Trials Enterprise of the Future

Session Details

Martina McMenamin
2016 (Montreal) Annual Meeting

Contributed Session
CAUSAL MODELLING IN TRIALS WITH SMALL SAMPLE SIZES

Session Details

Catherine Dillon
2016 (Montreal) Annual Meeting

Session Proposal
Central IRBs: Implementation, Effectiveness, and Optimization

Session Details

Catherine Dillon
2016 (Montreal) Annual Meeting

Session Proposal
Challenges and Solutions to the Coordination and Conduct of an Emergency Treatment Trial

Session Details

Caitlyn Ellerbe
2016 (Montreal) Annual Meeting

Session Proposal
Challenges of Implementing an Adaptive Design in an Academic Network Setting

Session Details

Dave Shade
2016 (Montreal) Annual Meeting

Contributed Session
CHARACTERIZATION OF DOUBLE-DATA-ENTRY IN DATA ENTRY SYSTEMS EMPLOYING MODERN INTERFACE ELEMENTS.

Session Details

Erika Cullingford
2016 (Montreal) Annual Meeting

Contributed Session
CLINICAL PROTOCOL DISSECTION: BEST PRACTICES TO REVIEWING A PROTOCOL THROUGH DIFFERENT ROLES AND STAGES FROM THE PERSPECTIVE OF A MULTI-PROJECT CRO

Session Details

Faye Williamson
2016 (Montreal) Annual Meeting

Contributed Session
Clinical Trial Design for Rare Diseases using Bayesian Bandit Models

Session Details

Jeannette Lee
2016 (Montreal) Annual Meeting

Contributed Session
Clinical Trial Participation Among HIV-infected Persons with Cancer

Session Details

Marie-Claude Boily
2016 (Montreal) Annual Meeting

Session Proposal
Clinical trial simulations: the when, where and what

Session Details

Valerie Durkalski
2016 (Montreal) Annual Meeting

Session Proposal
Collaborating with Patient Advocacy Groups at the Design Stage of your Clinical Trial, and Why is it so Important

Session Details

Tracey Davidson
2016 (Montreal) Annual Meeting

Contributed Session
Comparing the feasibility and acceptability of collecting patient reported outcomes using text message and paper diary

Session Details

Ayodele Odutayo
2016 (Montreal) Annual Meeting

Contributed Session
Comparison of Clinical Trial Protocols and Clinical Trial Registry Entries: A Cross-sectional Study

Session Details

Nicole Solomon
2016 (Montreal) Annual Meeting

Contributed Session
Comparison of Regression Imputation Methods for the Analysis of Time-to-event Endpoints Subject to Censoring

Session Details

Kaleab Abebe
2016 (Montreal) Annual Meeting

Contributed Session
Comparison of two Screening Strategies for Gestational Diabetes (GDM2) Trial: Design and Rationale

Session Details

Ashley Hogan
2016 (Montreal) Annual Meeting

Contributed Session
CONSIDERATIONS AND CHALLENGES FOR TRANSITION TO MOBILE ELECTRONIC PATIENT REPORTED OUTCOMES (ePRO) IN A LONG-TERM TRIAL WITH AN AGING AND DIVERSE POPULATION

Session Details

Donna Reidlinger
2016 (Montreal) Annual Meeting

Contributed Session
Consumers and the community as true partners in research

Session Details

Julian Wolfson, PhD
2016 (Montreal) Annual Meeting

Session Proposal
Courage, controversy, and clinical trials: Lessons from the Ebola epidemic

Session Details

Mary Putt, PhD, ScD
2016 (Montreal) Annual Meeting

Session Proposal
Crossover Trials: New Perspectives and Practical Implications for an Efficient Design

Session Details

Jane Perlmutter
2016 (Montreal) Annual Meeting

Contributed Session
CTTI’s Recommendations for Improving Informed Consent

Session Details

Shaun Treweek
2016 (Montreal) Annual Meeting

Session Proposal
Data and Biorepositories: Enhancing Collaborative Science

Session Details

Leonard Friedman
2016 (Montreal) Annual Meeting

Contributed Session
Data quality management in NeuroBANK; a clinical research data aggregation platform

Session Details

Doussau Adelaide
2016 (Montreal) Annual Meeting

Contributed Session
DECIPHERING ASSUMPTIONS ABOUT STEPPED WEDGE DESIGNS: THE CASE OF EBOLA VACCINE RESEARCH

Session Details

Richard Emsley
2016 (Montreal) Annual Meeting

Contributed Session
Design issues in trials of complex and digital interventions

Session Details

Dr Gillian Lancaster
2016 (Montreal) Annual Meeting

Session Proposal
Design, conduct and reporting of pilot and feasibility studies carried out in a health care setting in preparation for a randomised controlled trial testing the effectiveness of a complex intervention

Session Details

Caroline Brard
2016 (Montreal) Annual Meeting

Contributed Session
Designing a Bayesian randomized controlled trial in osteosarcoma: how to incorporate historical data?

Session Details

Dikla Shmueli-Blumberg
2016 (Montreal) Annual Meeting

Contributed Session
DEVELOPING A COMPREHENSIVE AND EFFECTIVE PROCESS FOR CLOSING OUT A STUDY: STRATEGIES FROM CLOSING OUT MULTI-SITE SUBSTANCE USE TREATMENT CLINICAL TRIALS

Session Details

Anne Hoehn
2016 (Montreal) Annual Meeting

Contributed Session
Developing a Data Management Plan for Electronic Medical Records Abstraction within Clinical Trials: A Report from NIDA CTN Studies

Session Details

Nisha Grover
2016 (Montreal) Annual Meeting

Contributed Session
DEVELOPING A MOBILE-BASED ePRO SYSTEM

Session Details

Joanna Crocker
2016 (Montreal) Annual Meeting

Contributed Session
Developing a Patient and public Involvement intervention to enhance Recruitment and Retention In UK Surgical Trials (PIRRIST)

Session Details

Yong Ma; Junshan Qiu
2016 (Montreal) Annual Meeting

Session Proposal
Development in Evaluating Cardiovascular Risk: Pre- and Post-marketing

Session Details

Magda Monreal
2016 (Montreal) Annual Meeting

Contributed Session
DEVELOPMENT OF A COLLABORATIVE APPROACH TO ACCRUAL OF ADOLESCENTS AND YOUNG ADULTS WITH CANCER TO CLINICAL TRIALS IN CANADA: A JOINT REPORT FROM THE PEDIATRIC C17 COUNCIL AND THE ADULT CANADIAN CANCER TRIALS GROUP.

Session Details

Zachary Sanchez
2016 (Montreal) Annual Meeting

Contributed Session
DEVELOPMENT OF A CORE OUTCOME SET FOR HYPEREMESIS GRAVIDARUM

Session Details

Gregory Aran
2016 (Montreal) Annual Meeting

Contributed Session
DEVELOPMENT OF A CORE OUTCOME SET FOR PEDIATRIC POSTOPERATIVE PAIN

Session Details

Dave Shade
2016 (Montreal) Annual Meeting

Contributed Session
DISTRIBUTION OF ITEM TYPES USED IN CASE REPORT FORMS IMPLEMENTED IN MODERN DATA MANAGEMENT SYSTEMS.

Session Details

Shaun Treweek
2016 (Montreal) Annual Meeting

Contributed Session
Do pragmatic trials trade-off internal validity for external validity?

Session Details

Michael Grayling
2016 (Montreal) Annual Meeting

Contributed Session
Do single-arm trials have a role in drug development plans incorporating randomised trials?

Session Details

Nicole C. Close, PhD
2016 (Montreal) Annual Meeting

Session Proposal
Don't Be Afraid: Risk Based Monitoring at a Deconstructed Level for Implementation

Session Details

Erin Gabriel
2016 (Montreal) Annual Meeting

Contributed Session
Early Phase Transmission Blocking Vaccine Trials: Evaluation without Validated Surrogates

Session Details

Emily V. Dressler
2016 (Montreal) Annual Meeting

Session Proposal
Early-Phase Designs for Contemporary Dose-Finding Problems in Oncology

Session Details

Cynthia L Green & Borje Darpo
2016 (Montreal) Annual Meeting

Session Proposal
ECG Assessment in Early Clinical Trials

Session Details

Aenne Glass
2016 (Montreal) Annual Meeting

Contributed Session
EFFECT OF 10 DIFFERENT POLYMORPHISMS ON PREOPERATIVE VOLUMETRIC CHARACTERISTICS OF GLIOBLASTOMA MULTIFORME - RESULTS OF A PILOT STUDY

Session Details

Kristen Cunanan
2016 (Montreal) Annual Meeting

Contributed Session
Efficient Basket Trial Designs

Session Details

Abigail Shoben
2016 (Montreal) Annual Meeting

Contributed Session
Efficient designs for comparing control, treatment, and treatment plus in randomized trials

Session Details

Steven A. Julious
2016 (Montreal) Annual Meeting

Session Proposal
Efficient study designs in clinical research

Session Details

J Athene Lane
2016 (Montreal) Annual Meeting

Contributed Session
Enhancing patient and public involvement in trial oversight committees through qualitative research with eight large trials facing challenges

Session Details

Dr. Michael C Sachs
2016 (Montreal) Annual Meeting

Session Proposal
Episodic, rare and hard to measure outcomes in infectious diseases: challenges to clinical trial design

Session Details

Leila Rooshenas
2016 (Montreal) Annual Meeting

Contributed Session
EQUIPOISE IN ACTION: AN INVESTIGATION ACROSS SIX PRAGMATIC RANDOMIZED CONTROLLED TRIALS

Session Details

Karla Hemming
2016 (Montreal) Annual Meeting

Contributed Session
Establishing an upper bound on the optimal cluster size in cluster randomised trials with a limited number of clusters

Session Details

Andrew Forbes
2016 (Montreal) Annual Meeting

Contributed Session
Estimation in multiple period cluster randomized trials with non-uniform correlation structure

Session Details

Dean Fergusson
2016 (Montreal) Annual Meeting

Session Proposal
Ethical challenges in pragmatic comparative effectiveness trials

Session Details

Dean Fergusson
2016 (Montreal) Annual Meeting

Session Proposal
Ethical challenges in pragmatic comparative effectiveness trials

Session Details

Dean Fergusson
2016 (Montreal) Annual Meeting

Session Proposal
Ethical challenges in pragmatic comparative effectiveness trials

Session Details

Ken Cheung
2016 (Montreal) Annual Meeting

Session Proposal
Evaluating Precision Medicine in Clinical Trials

Session Details

Andisheh Bakhshi
2016 (Montreal) Annual Meeting

Contributed Session
EVALUATION OF THE WORKING HEALTH SERVICE SCOTLAND

Session Details

J. Michael Dean
2016 (Montreal) Annual Meeting

Session Proposal
Evolution and Function of Clinical Research Networks: What drives success?

Session Details

Marinella Temprosa
2016 (Montreal) Annual Meeting

Session Proposal
Expanding Your Reach: Innovations and opportunities for remote participant visits to boost retention and enrollment in research studies

Session Details

Thomas Jaki
2016 (Montreal) Annual Meeting

Contributed Session
Factorial versus multi-arm multi-stage designs in clinical trials

Session Details

Amy Xia
2016 (Montreal) Annual Meeting

Session Proposal
FDA IND Reporting Final Rule Compels a New Dialog among the DMC, Sponsor and FDA

Session Details

Jennifer Mischke
2016 (Montreal) Annual Meeting

Contributed Session
FDA Pre-Submission Program Overview and How to Effectively use the Program to Move a Device to the US Market

Session Details

Samantha Hinsley
2016 (Montreal) Annual Meeting

Contributed Session
FUTILITY ANALYSIS CONSIDERATIONS FOR A PHASE II TRIAL WITH SHORT TERM NON-INFERIORITY AND LONG TERM SUPERIORITY CO-PRIMARY ENDPOINTS

Session Details

Jose-Miguel Yamal
2016 (Montreal) Annual Meeting

Contributed Session
Futility Trials Revisited: Do They Still Have a Place in Clinical Trial Research?

Session Details

Lee McDaniel
2016 (Montreal) Annual Meeting

Contributed Session
Generating survival times to simulate additive hazards models

Session Details

Toshimitsu Hamasaki
2016 (Montreal) Annual Meeting

Contributed Session
Group-sequential three-arm noninferiority clinical trial designs

Session Details

Prof Jonathan Cook
2016 (Montreal) Annual Meeting

Session Proposal
Guidance on specifying the target difference (“effect size”) for a RCT

Session Details

Leila Rooshenas
2016 (Montreal) Annual Meeting

Contributed Session
HOW PRE-TRIAL RESEARCH CAN TRANSFORM PRE-SPECIFIED RANDOMISED CONTROLLED TRIAL DESIGN: A CASE STUDY AND IMPLICATIONS FOR FUTURE PRACTICE

Session Details

David Beard
2016 (Montreal) Annual Meeting

Contributed Session
IMBALANCE IN RECRUITMENT BETWEEN SITES IN SURGICAL TRIALS: HOW PROBLEMATIC?

Session Details

Jonathan Cook
2016 (Montreal) Annual Meeting

Contributed Session
IMPACT OF TIMING OF FOLLOW-UP UPON OUTCOME IN A SURGICAL TRIAL

Session Details

Jennifer Gassman
2016 (Montreal) Annual Meeting

Contributed Session
Implementation of a three-stage recruitment tracking system in the Blood Pressure in Hemodialysis Pilot (BID) RCT comparing blood pressure level treatment arms

Session Details

Carolyn Wilson
2016 (Montreal) Annual Meeting

Contributed Session
Implementation of a web-based screen failure log with real-time data collection and assessment facilitated timely modification of eligibility criteria in an adjuvant lung cancer immunotherapy trial

Session Details

Wenle Zhao
2016 (Montreal) Annual Meeting

Contributed Session
IMPLEMENTATION OF BETTER AND SIMPLE ALTERNATIVES TO PERMUTED BLOCK DESIGN

Session Details

Rebecca Lewis
2016 (Montreal) Annual Meeting

Contributed Session
Implementing Electronic Data Capture (EDC) – Lessons Learnt

Session Details

Thomas Jemielita
2016 (Montreal) Annual Meeting

Contributed Session
Improved Power in Crossover Designs through Linear Combinations of Baselines

Session Details

Akshata Ashokkumar
2016 (Montreal) Annual Meeting

Contributed Session
IMPROVING CLINICAL TRIAL EFFICIENCY: USE OF CENTRAL IRB AND MASTER TRIAL AGREEMENTS

Session Details

Anne Duncan
2016 (Montreal) Annual Meeting

Contributed Session
Improving trial questionnaire response rates using behaviour change theory.

Session Details

Peiyao Cheng
2016 (Montreal) Annual Meeting

Contributed Session
INCREASE THE PRECISION OF EFFECT SIZE ESTIMATE IN TIME TO EVENT DATA WITH INTERVAL CENSORING USING UNBALANCED DESIGN

Session Details

Robert Lindblad, MD
2016 (Montreal) Annual Meeting

Session Proposal
Initiating a Clinical Trial in an Epidemic Hot Zone; The Sierra Leone Ebola Experience

Session Details

Haitao Pan
2016 (Montreal) Annual Meeting

Session Proposal
Innovative Trial Designs for Precision Medicine

Session Details

Judy Needham
2016 (Montreal) Annual Meeting

Contributed Session
Integrating Patient / Public Involvement in the NCIC Clinical Trials Group

Session Details

Chris Cook
2016 (Montreal) Annual Meeting

Contributed Session
INTEGRATING TRADITIONAL ELECTRONIC DATA CAPTURE (EDC) WITH NEW SYSTEMS

Session Details

Victoria Borg Debono
2016 (Montreal) Annual Meeting

Contributed Session
INTERIM DATA SHARING; WHAT INTERIM RESULTS OR INFORMATION SHOULD OR SHOULDN'T BE SHARED DURING THE INTERIM OF A RANDOMIZED CONTROLLED TRIAL WITH THOSE RESPONSIBLE FOR THE CONDUCT OF THE TRIAL?

Session Details

Fangxin Hong
2016 (Montreal) Annual Meeting

Session Proposal
Interim monitoring for clinical trials: then and now

Session Details

Koko Asakura
2016 (Montreal) Annual Meeting

Contributed Session
Interim monitoring of clinical trials with co-primary endpoints using predicted intervals

Session Details

Neal Oden
2016 (Montreal) Annual Meeting

Contributed Session
Interim Monitoring of Non-inferiority Trials

Session Details

Norma Diaz-Mayoral
2016 (Montreal) Annual Meeting

Contributed Session
INVENTORY MANAGEMENT: UTILIZATION OF THE BSI SYSTEM TO INTEGRATE SPECIMEN-RELATED DATA

Session Details

Andrew Cook
2016 (Montreal) Annual Meeting

Contributed Session
Involving Clinical Experts in Prioritising Topics for Pragmatic Trials: A Factorial Randomised Controlled Trial

Session Details

Paul Brocklehurst
2016 (Montreal) Annual Meeting

Contributed Session
It is not all about effectiveness. The use of efficiency measures in evaluative designs.

Session Details

Todd MacKenzie
2016 (Montreal) Annual Meeting

Session Proposal
Joint modeling in clinical trials

Session Details

Julie Croft
2016 (Montreal) Annual Meeting

Contributed Session
Key Trial & Data Management Considerations for Planning Surgical Trials

Session Details

Annabelle South (TBC)
2016 (Montreal) Annual Meeting

Session Proposal
Knowledge translation for clinical trials: experiences from trials in Canada, the UK and Africa

Session Details

Marina Djurfeldt
2016 (Montreal) Annual Meeting

Contributed Session
LAUNCHING THE CANADIAN CANCER TRIALS GROUP SITE TRAINING INITIATIVE

Session Details

Lauren Yesko
2016 (Montreal) Annual Meeting

Contributed Session
Lessons Learned In Collecting Participant Reported Outcome Data via Web-Based Data Systems

Session Details

Ruiqi Zhang
2016 (Montreal) Annual Meeting

Contributed Session
Long term follow-up in randomised trials with delayed intervention for the control group

Session Details

Brenda Kurland
2016 (Montreal) Annual Meeting

Session Proposal
Low Dose Computed Tomography (LDCT) screening for lung cancer: Opportunities for refinement using quantitative imaging biomarkers

Session Details

Rebecca Neiberg
2016 (Montreal) Annual Meeting

Contributed Session
MANAGING DATA QUALITY OF PARTICIPANT WEIGHTS UPLOADED FROM SMART SCALES: THE STUDY OF NOVEL APPROACHES TO PREVENTION CLINICAL TRIAL – EXTENSION PHASE

Session Details

Julian Wolfson
2016 (Montreal) Annual Meeting

Contributed Session
Matching-based sensitivity analysis for assessing mediation in randomized trials

Session Details

Annabelle South
2016 (Montreal) Annual Meeting

Contributed Session
Measuring the impact of clinical trials: developing and applying a set of impact metrics

Session Details

Jeannette Lee
2016 (Montreal) Annual Meeting

Contributed Session
MEDICATION ADHERENCE IN A STUDY TO PREVENT VAGINAL INFECTIONS

Session Details

Matthew Sims
2016 (Montreal) Annual Meeting

Contributed Session
METHODLOGICAL QUALITY AND RISK OF BIAS ASSESSMENTS IN ORTHOPEDIC SURGERY SYSTEMATIC REVIEWS

Session Details

Leila Rooshenas
2016 (Montreal) Annual Meeting

Contributed Session
METHODS FOR SELECTING HEALTH CONCEPTS AND DOMAINS FOR THE DEVELOPMENT OF PATIENT REPORTED OUTCOME MEASURES (PROMS): A CASE STUDY

Session Details

Patricia Feeney
2016 (Montreal) Annual Meeting

Contributed Session
Methods to minimize bias during the analysis of open-label, randomized controlled trials

Session Details

Tolulope Sajobi
2016 (Montreal) Annual Meeting

Contributed Session
Minimal Sufficient Balance Randomization for Endovascular Stroke Trials: Results from the ESCAPE trial

Session Details

Marion Campbell
2016 (Montreal) Annual Meeting

Contributed Session
Missing data matter: should trials routinely report their Fragility Index?

Session Details

Karla Hemming
2016 (Montreal) Annual Meeting

Contributed Session
MODELLING DIFFERENTIAL CLUSTERING AND TREATMENT EFFECT HETEROGENEITY IN PARALLEL AND STEPPED WEDGE CLUSTER RANDOMISED TRIALS

Session Details

Annabelle South
2016 (Montreal) Annual Meeting

Contributed Session
Models and impact of patient and public involvement in studies carried out by the MRC Clinical Trials Unit at UCL: Findings from 10 case studies

Session Details

Anne Hoehn
2016 (Montreal) Annual Meeting

Contributed Session
Monitoring Medication Adherence Using a Mobicontrol Application: A Case Study

Session Details

Suzanne Breeman
2016 (Montreal) Annual Meeting

Contributed Session
MULTI-ARM RANDOMISED CONTROLLED TRIALS: A TRIAL MANAGERS PERSPECTIVE

Session Details

Claire Cochran
2016 (Montreal) Annual Meeting

Contributed Session
Negotiating hurdles, providing solutions to problems; Sharing the Challenges and lessons of managing a seven year International RCT

Session Details

Rick Chappell
2016 (Montreal) Annual Meeting

Contributed Session
Null Hypothesis Scales in Non-Inferiority Trials

Session Details

Catherine Klersy
2016 (Montreal) Annual Meeting

Contributed Session
One size does not fit all: adherence to STROBE guidelines in sample size calculations from the perspective of an Ethical Committee

Session Details

Andrew Forbes
2016 (Montreal) Annual Meeting

Contributed Session
Optimal allocation in stepped wedge designs

Session Details

Rachael Williams
2016 (Montreal) Annual Meeting

Contributed Session
Optimising the drug development pathway and life cycle management through the integration of observational and interventional data and expertise

Session Details

Bray Patrick-Lake
2016 (Montreal) Annual Meeting

Session Proposal
Overcoming Barriers to Effective Research Partnerships with Patient Groups

Session Details

William Meurer, MD, MS
2016 (Montreal) Annual Meeting

Session Proposal
Partnering biostatisticians and clinicians to train the next generation of neurological clinical trialists: the National Institutes of Neurological Disorders and Stroke Clinical Trials Methodology Course (NINDS-CTMC)

Session Details

Gail McDonald
2016 (Montreal) Annual Meeting

Contributed Session
Patient Retention in Clinical Trials – The Canadian Cancer Trials Group (CCTG) Group Experience with Withdrawal of Consent and Lost to Follow Up

Session Details

Agnieshka Baumritter
2016 (Montreal) Annual Meeting

Contributed Session
Pilot Study of a Tiered Approach to ROP Screening (TARP) using a Weight Gain Predictive Model and a Telemedicine System

Session Details

Janet Holbrook
2016 (Montreal) Annual Meeting

Contributed Session
PLACEBOS ARE MORE EFFECTIVE IN WOMEN THAN MEN WITH ASTHMA

Session Details

Adrian Hernandez
2016 (Montreal) Annual Meeting

Session Proposal
Planning for the Future – Expanding Opportunities for Pragmatic Trials

Session Details

Hongsheng Wu
2016 (Montreal) Annual Meeting

Contributed Session
Power Calculation for stepped wedge designs with pre-post evaluations

Session Details

Shun Fu Lee
2016 (Montreal) Annual Meeting

Contributed Session
Power of the adjusted Q statistic for the meta-analysis of cluster randomization trials.

Session Details

Robert Lindblad, MD
2016 (Montreal) Annual Meeting

Session Proposal
Practical Experiences facilitating the use of “BIG” Health Care Clinical Data to Conduct Clinical Research

Session Details

Chad Winch
2016 (Montreal) Annual Meeting

Contributed Session
PRACTICAL IMPLEMENTATION OF AN ADAPTIVE CLINICAL TRIAL DESIGN IN A MULTI-STAGE RANDOMIZED PHASE II STUDY OF NOVEL COMBINATION THERAPY FOR THE TREATMENT OF RELAPSED AND REFRACTORY AGGRESSIVE B-CELL LYMPHOMA: CANADIAN CANCER TRIALS GROUP LY.17

Session Details

Scott Evans
2016 (Montreal) Annual Meeting

Session Proposal
Pragmatic Trials

Session Details

Nicola Soriani
2016 (Montreal) Annual Meeting

Contributed Session
PREDICTING OUTCOMES IN A CLINICAL TRIAL: A SUPER LEARNER APPROACH

Session Details

TINGTING LI
2016 (Montreal) Annual Meeting

Contributed Session
Presenting Interim Clinical Trial Data for Decision Makers with Diverse Backgrounds

Session Details

Bray Patrick-Lake
2016 (Montreal) Annual Meeting

Session Proposal
Proactively Addressing Enrollment Challenges – CTTI’s Recommendations for Improving Recruitment Planning and Informed Consent

Session Details

Nicola Greenlaw
2016 (Montreal) Annual Meeting

Contributed Session
Problems, solutions and challenges using routinely collected prescription dispensing data in a randomized controlled trial setting

Session Details

Lynda Ugwu
2016 (Montreal) Annual Meeting

Session Proposal
Prospective Individual Participant Data Meta-Analysis

Session Details

Jennifer Snyder
2016 (Montreal) Annual Meeting

Contributed Session
Provincial Centralized Research Ethics Boards: How a Canadian Clinical Trial Sponsor Supports the Quebec Model

Session Details

Alexander Demand
2016 (Montreal) Annual Meeting

Contributed Session
Publication Bias and Non-Reporting Found in Majority of Systematic Reviews and Meta-Analyses in Anesthesiology Journals

Session Details

Cole Wayant
2016 (Montreal) Annual Meeting

Contributed Session
Publication bias evaluations are not routinely conducted in clinical oncology systematic reviews

Session Details

Susan Kunselman
2016 (Montreal) Annual Meeting

Contributed Session
QUALITY ASSURANCE PROCESSES FOR PULMONARY FUNCTION TESTS IN AN ASTHMA CLINICAL TRIAL: THE ASTHMANET BARD TRIAL

Session Details

Tracey Serpi
2016 (Montreal) Annual Meeting

Contributed Session
Quality Studies: Using Risk Based Monitoring in the Department of Veterans Affairs Cooperative Studies Program to Enhance Human Subject Protection and Data Integrity

Session Details

Catherine Oldenburg
2016 (Montreal) Annual Meeting

Contributed Session
RANDOMIZED BY NATURE: CLINICAL TRIALS WITH THRESHOLD TREATMENT ASSIGNMENT

Session Details

Larisa Tereshchenko
2016 (Montreal) Annual Meeting

Contributed Session
Randomized Controlled Trial Adaptive CRT effect on ELectrical dysSYNChrony (aCRT ELSYNC): study design

Session Details

Pamela Shaw
2016 (Montreal) Annual Meeting

Session Proposal
Randomized controlled trials of behavior economics interventions: Examples and considerations for design

Session Details

Dave DeMets
2016 (Montreal) Annual Meeting

Contributed Session
Recommendations from the Clinical Trials Transformation Initiative Data Monitoring Committee Project

Session Details

David DeMets
2016 (Montreal) Annual Meeting

Session Proposal
Recommendations from the Clinical Trials Transformation Initiative Data Monitoring Committee Project

Session Details

Dena Howard
2016 (Montreal) Annual Meeting

Contributed Session
Recommendations on multiple-testing adjustment in multi-arm trials with correlated hypotheses

Session Details

Safawa Huq
2016 (Montreal) Annual Meeting

Contributed Session
Recruitment Strategies Implemented in the “B Cell Targeted Treatment in Myasthenia Gravis (BeatMG)” Trial: Understanding the Approach to Successful Recruitment for a Rare Disease Population Utilizing a Clinical Trial Network

Session Details

Aenne Glass
2016 (Montreal) Annual Meeting

Contributed Session
REDUCTION OF RADIATION EXPOSURE DURING ABLATION OF ATRIAL FIBRILLATION

Session Details

Marc Schwartz
2016 (Montreal) Annual Meeting

Contributed Session
Reproducible Research and Dynamically Generated Biostatistical Analyses

Session Details

Radhika Kondapaka
2016 (Montreal) Annual Meeting

Contributed Session
RESOLUTION OF ADVERSE EVENTS: DISCUSSION OF INNOVATIVE SOLUTIONS

Session Details

Katie Gillies
2016 (Montreal) Annual Meeting

Contributed Session
Retention in randomised trials: What matters to Trial Managers?

Session Details

Caroline Hurley
2016 (Montreal) Annual Meeting

Contributed Session
Risk assessment tools for clinical trial monitoring: a systematic review

Session Details

Amparo Casanova
2016 (Montreal) Annual Meeting

Contributed Session
SAMPLE SIZE CALCULATIONS FOR CLUSTER CROSSOVER RANDOMIZED TRIALS

Session Details

Brittany Schwefel
2016 (Montreal) Annual Meeting

Contributed Session
Sample Size Re-estimation of Event-Driven Trials with Composite Events and Delayed Data Ascertainment

Session Details

Laura Smeaton
2016 (Montreal) Annual Meeting

Contributed Session
SCREENING AND ENROLLMENT BY SEX IN HIV CLINICAL TRIALS – A CROSS-PROTOCOL ANALYSIS

Session Details

Lucille Sebastian
2016 (Montreal) Annual Meeting

Contributed Session
Screening logs – opportunities and cautions for central monitoring

Session Details

Gui-shuang Ying
2016 (Montreal) Annual Meeting

Contributed Session
SECONDARY ANALYSIS of CLINICAL TRIALS DATA – A BIOSTATISTICIAN’S EXPERIENCE

Session Details

Andres Tellez
2016 (Montreal) Annual Meeting

Contributed Session
Selective Withdrawal in an Open Label Clinical Trial: CRLX101 in Non-Small Cell Lung Cancer

Session Details

Hwasoon Kim
2016 (Montreal) Annual Meeting

Contributed Session
Simulation Study for Sample Size Re-Estimation Methods Based on Log-Rank Statistics for Non-Inferiority Studies with Censored Survival Data

Session Details

Dario Gregori
2016 (Montreal) Annual Meeting

Contributed Session
Some insights in setting non-inferiority margin when information is available on the trial arms effects

Session Details

Soeun Kim
2016 (Montreal) Annual Meeting

Contributed Session
Standardized Global Statistical Test for Combining Multiple Outcomes in Clinical Trials

Session Details

Zhibao Mi
2016 (Montreal) Annual Meeting

Contributed Session
Statistical Assessment and Adjustment of Imbalance Caused Biased Treatment Effect

Session Details

Rosemarie Mick
2016 (Montreal) Annual Meeting

Session Proposal
Statistical Challenges in Immuno-Oncology

Session Details

Emmanuel Sampene
2016 (Montreal) Annual Meeting

Contributed Session
Statistical Inference in Randomized Consent Designs in the Presence of Hawthorne Effects

Session Details

Anne Lindblad
2016 (Montreal) Annual Meeting

Contributed Session
STATISTICAL MONITORING IN CLINICAL TRIALS: AN EXPERIMENT TO DETECT FABRICATED DATA

Session Details

Ranran Dong
2016 (Montreal) Annual Meeting

Contributed Session
Stepped Wedge Cluster Randomized Controlled Trials with Two Layers of Clustering: Designs and Comparisons of Power

Session Details

Amber Randall
2016 (Montreal) Annual Meeting

Contributed Session
Strategic Considerations for CDISC Implementation

Session Details

Cindy Jacobson
2016 (Montreal) Annual Meeting

Contributed Session
STRATEGIES IMPLEMENTED FOR OPTIMIZED DISPENSING OF AN INVESTIGATIONAL NEW DRUG DELIVERY DEVICE IN A MULTI-SITE HIV PREVENTION CLINICAL TRIAL

Session Details

Lynda Constable
2016 (Montreal) Annual Meeting

Contributed Session
Strategies to improve recruitment in surgical trials: targeting patient and clinical preferences

Session Details

Briana Cameron
2016 (Montreal) Annual Meeting

Contributed Session
Stratification in the two-stage randomized trial design for testing treatment, self-selection, and treatment preference effects

Session Details

Pamela Tenaerts
2016 (Montreal) Annual Meeting

Session Proposal
Streamlining Clinical Trials: Putting Words into Action

Session Details

John Alexander
2016 (Montreal) Annual Meeting

Session Proposal
Streamlining clinical trials: the practicalities

Session Details

Susanna Jacobus
2016 (Montreal) Annual Meeting

Session Proposal
Strengthening the Oncology Cooperative Group Community-Based Clinical Research Enterprise

Session Details

Elizabeth Avery
2016 (Montreal) Annual Meeting

Contributed Session
STUDY AND DATA MANAGEMENT OF A CHURCH BASED CBPR INTERVENTION DEVELOPMENT PROJECT: LESSONS LEARNED

Session Details

Elias Klemperer
2016 (Montreal) Annual Meeting

Contributed Session
Study characteristics account for the majority of variance in clinical trials of medications for alcohol use disorders: A meta-analysis

Session Details

Nigel Scott
2016 (Montreal) Annual Meeting

Contributed Session
STUDY DRUG MANAGEMENT SYSTEM WITHIN AN INTERNATIONAL TRIALS CONSORTIUM

Session Details

Katelyn Garcia
2016 (Montreal) Annual Meeting

Contributed Session
SUSPENSION AND INTERVENTION MODIFICATION FOR PREGNANCIES IN A WEIGHT GAIN PREVENTION TRIAL: THE STUDY OF NOVEL APPROACHES TO PREVENTION CLINICAL TRIAL

Session Details

Shokoufeh Khalatbari
2016 (Montreal) Annual Meeting

Contributed Session
TATUM: A WEB-BASED TOOL FOR OBTAINING A TREATMENT ALLOCATION IN A RANDOMIZED CONTROLLED CLINICAL TRIAL WITH A BUILT IN TRACKING SYSTEM FOR THE MANAGEMENT OF THE RANDOMIZATION PROCESS

Session Details

Michaela Goodwin
2016 (Montreal) Annual Meeting

Contributed Session
Testing methods to increase response to questionnaires in a longitudinal study

Session Details

Luigia Scudeller
2016 (Montreal) Annual Meeting

Contributed Session
The BISON (Bloodstream Infections and Sepsis Outcomes measurement Network) initiative: systematic overview of outcomes used in systematic reviews on interventions for sepsis and/or bloodstream infections

Session Details

Valeria Musella
2016 (Montreal) Annual Meeting

Contributed Session
The challenge of electronic case report form in investigators-initiated studies

Session Details

Pamela Tenaerts, MD, MBA
2016 (Montreal) Annual Meeting

Contributed Session
The Clinical Trials Transformation Initiative: Improving the Quality and Efficiency of Clinical Trials

Session Details

Eve Jelstrom
2016 (Montreal) Annual Meeting

Contributed Session
THE CREATION, DEVELOPMENT AND USE OF AN ELECTRONIC SITE VISIT REPORT

Session Details

Ines Rombach
2016 (Montreal) Annual Meeting

Contributed Session
THE CURRENT PRACTICE OF HANDLING AND REPORTING MISSING OUTCOME DATA IN 8 WIDELY-USED PATIENT REPORTED OUTCOME MEASURES IN PUBLICATIONS OF RANDOMIZED CONTROLLED TRIALS: A REVIEW OF THE CURRENT LITERATURE

Session Details

Rebecca Elmore
2016 (Montreal) Annual Meeting

Contributed Session
THE ENVIRONMENTAL POLYMORPHISMS REGISTRY (EPR): A RESOURCE TO FACILITATE RECRUITMENT FOR CLINICAL STUDIES

Session Details

Cory Goldstein
2016 (Montreal) Annual Meeting

Contributed Session
THE ETHICS OF PRAGMATIC RANDOMIZED CONTROLLED TRIALS IN COMPARATIVE EFFECTIVENESS RESEARCH

Session Details

Simon Bacon
2016 (Montreal) Annual Meeting

Session Proposal
The International Behavioural Trials Network (IBTN): An International effort to improve the rigor and impact of behavioral clinical trials

Session Details

Norma Diaz-Mayoral
2016 (Montreal) Annual Meeting

Contributed Session
THE RELOCATION OF A SPECIMEN COLLECTION: COORDINATION OF LOGISTICS, SELECTING THE RIGHT PACKAGING, DATA MAPPING AND LESSONS LEARNED

Session Details

William Coar
2016 (Montreal) Annual Meeting

Contributed Session
The Right Time to Implement CDISC

Session Details

Rui (Sammi ) Tang
2016 (Montreal) Annual Meeting

Session Proposal
The Statistical Challenges in Recent Development of Personalized Medicine – through biomarker subgroup identification to companion diagnostic device development

Session Details

Karla Hemming
2016 (Montreal) Annual Meeting

Session Proposal
The stepped wedge cluster randomised trial – design and analysis and current challenges

Session Details

Navneet Hakhu
2016 (Montreal) Annual Meeting

Contributed Session
THE THREE PILLARS OF A SUCCESSFUL DATA MONITORING COMMITTEE ORGANIZATIONAL MEETING AND INTERIM MONITORING OF A RANDOMIZED CLINICAL TRIAL

Session Details

Kevin Wilson
2016 (Montreal) Annual Meeting

Contributed Session
The Use of Data Visualization Tools to Monitor Key Clinical Trial Activities

Session Details

Joseph Ross
2016 (Montreal) Annual Meeting

Contributed Session
The Yale Open Data Access (YODA) Project: Lessons Learned in Clinical Trial Data Sharing

Session Details

Shaun Treweek
2016 (Montreal) Annual Meeting

Contributed Session
Time well spent? A comparison of the work associated with collecting primary and secondary outcomes.

Session Details

Graham Quinn
2016 (Montreal) Annual Meeting

Contributed Session
Timely implementation of an ROP Telemedicine System

Session Details

Roger Lewis, MD, PhD
2016 (Montreal) Annual Meeting

Session Proposal
Training academic clinicians and biostatisticians to design and simulate adaptive clinical trials: the National Institutes of Neurological Disorders and Stroke Clinical Trials Methodology Advanced Course

Session Details

Wendy Parulekar
2016 (Montreal) Annual Meeting

Session Proposal
Translational scientists/ Bioinformaticians and Biostatisicians – Menage a Trois or Melange a Trois

Session Details

Natalie Blencowe
2016 (Montreal) Annual Meeting

Contributed Session
Uncovering the influence of performance bias: a methodological study nested within an RCT

Session Details

Wendy Parulekar
2016 (Montreal) Annual Meeting

Session Proposal
Use of administrative and registry data in clinical trials

Session Details

Dikla Blumberg
2016 (Montreal) Annual Meeting

Contributed Session
USE OF CERTIFICATES OF CONFIDENTIALITY TO PROTECT RESEARCH PARTICIPANTS’ PRIVACY IN RESPONSE TO LEGAL DEMANDS

Session Details

Ashley Case
2016 (Montreal) Annual Meeting

Contributed Session
Use of EDC Systems to Monitor Informed Contents Remotely

Session Details

Lisa A. Marsch, PhD and Carmen Rosa, MS
2016 (Montreal) Annual Meeting

Session Proposal
Use of Mobile Health Technologies in Pragmatic Clinical Trials

Session Details

Paul VanVeldhuisen, PhD
2016 (Montreal) Annual Meeting

Session Proposal
Using “BIG” Health Care Clinical Data to Conduct Clinical Research

Session Details

Stephanie DuBose
2016 (Montreal) Annual Meeting

Contributed Session
USING A PATIENT REGISTRY TO CONDUCT NON-CLINIC ENGAGED STUDIES

Session Details

Scott Evans
2016 (Montreal) Annual Meeting

Contributed Session
USING ENDPOINTS TO ANALYZE PATIENTS RATHER THAN PATIENTS TO ANALYZE ENDPOINTS: A PRE-TRIAL SUBSTUDY TO DEVELOP A GLOBAL OUTCOME FOR CLINICAL TRIALS

Session Details

Matthias Pierce
2016 (Montreal) Annual Meeting

Contributed Session
Using trials to identify personalised treatment rules

Session Details

Thuong La
2016 (Montreal) Annual Meeting

Contributed Session
Utilizing cloud-based file synchronization platform for real-time data transfer, central storage and collaboration network

Session Details

Kirsty Loudon
2016 (Montreal) Annual Meeting

Contributed Session
Validity and Reliability of PRECIS-2 – a tool designed to help trialists match their trial design decisions to the needs of those they hope will use the results

Session Details

Lucille Sebastian
2016 (Montreal) Annual Meeting

Contributed Session
Variation in routine follow up for preterm babies: implications for clinical trials

Session Details

Loretta Davies
2016 (Montreal) Annual Meeting

Contributed Session
WHAT CAN WE LEARN FROM EXPERIENCE? IMPACT OF HEALTHCARE PROVIDER EFFECTS IN THE TOTAL OR PARTIAL KNEE ARTHROPLASTY TRIAL (TOPKAT)

Session Details

TBC
2016 (Montreal) Annual Meeting

Session Proposal
What happens when a trial is interrupted? How to deal with suspension of randomisation and restart your trial

Session Details

Kerry Avery
2016 (Montreal) Annual Meeting

Contributed Session
What is the effect of item order (patient reported outcomes first or last?) in a questionnaire on the measurement and prioritisation of outcomes: a randomised controlled trial

Session Details

Todd MacKenzie
2016 (Montreal) Annual Meeting

Contributed Session
Who Are the Compliers? Reporting Baseline Characteristics to Accompany the Causal Effect of Treatment

Session Details

Michael S. Lauer
2015 (Arlington) Annual Meeting

Founders Lecture
A Future for Clinical Trials? An NIH Perspective

Study Team
2015 (Arlington) Annual Meeting

Trial of the Year Award
Mechanical versus Manual Chest Compression for Out-of-Hospital Cardiac Arrest (PARAMEDIC)

James D. Neaton
2015 (Arlington) Annual Meeting

Curtis Meinert Lecture
International Trials and Tribulations

Steve Goodman
2015 (Arlington) Annual Meeting

Special Presentation
Remembering David Sackett

Cook et al
2015 (Arlington) Annual Meeting

Special Presentation
Workshop - Conducting Valid Trials: the Critical (and Misunderstood) Roles of Randomization and Complete Follow-Up

Jennifer Gassman
2015 (Arlington) Annual Meeting

Fellows Presentation
Presentation of the Class of 2015 Fellows

KyungMann Kim
2015 (Arlington) Annual Meeting

Presidential Welcome

Shona Silvester
2015 (Arlington) Annual Meeting

Contributed Session
‘MINIMUM TIME/MAXIMUM QUALITY’: AUTOMATED TRACKING SYSTEMS TO IMPROVE EFFICIENCY, REDUCE THE RISK OF HUMAN ERROR AND ENSURE TIMELY DATA COLLECTION

Session Details

Edward Gaunt
2015 (Arlington) Annual Meeting

Contributed Session
A Centralized Approach to Mailing and Materials Distribution in the Gulf Long-Term Follow-up Study (GuLF STUDY)

Session Details

Raymond Carragher
2015 (Arlington) Annual Meeting

Contributed Session
A COMPARISON OF SOME METHODS FOR DETECTION OF SAFETY SIGNALS IN RANDOMISED CONTROLLED TRIALS

Session Details

Danila Azzolina
2015 (Arlington) Annual Meeting

Contributed Session
A decision making tool for non-pharmacological treatment in knee osteoarthritis

Session Details

Dong-Yun Kim
2015 (Arlington) Annual Meeting

Contributed Session
A fully sequential test for treatment effects using censored data in multi-center clinical trials

Session Details

Giulia Lorenzoni
2015 (Arlington) Annual Meeting

Contributed Session
A latent Gamma model for modelling the simultaneous effect of treatment on WOMAC subscales in osteoarthritis RCTs

Session Details

Qian Wu
2015 (Arlington) Annual Meeting

Contributed Session
A New Approach of Incorporating Biomarker Information to Identify Patient Subgroups with Enhanced Treatment Effect for Personalized Medicine

Session Details

Doussau Adelaide
2015 (Arlington) Annual Meeting

Contributed Session
A new approach to integrate toxicity grade and repeated treatment cycles in the analysis and reporting of phase I dose-finding trials

Session Details

Matthew Liang
2015 (Arlington) Annual Meeting

Contributed Session
A NOVEL USER SURVEY TO DETERMINE A CLINICALLY MEANINGFUL EFFECT SIZE IN THE PLANNING OF CSP#590 (Li+)

Session Details

Jieling Miao
2015 (Arlington) Annual Meeting

Contributed Session
A SIMPLE APPROACH FOR INCORPORATING MULTIPLE TOXICITY THRESHOLDS IN PHASE I TRIALS

Session Details

Jonathan Cook
2015 (Arlington) Annual Meeting

Contributed Session
A systematic review of the use of an expertise-based randomised trial design

Session Details

Melanie Prague
2015 (Arlington) Annual Meeting

Contributed Session
Accounting for informative missingness, interaction and interference in cluster randomized trials.

Session Details

Nolan Wages
2015 (Arlington) Annual Meeting

Contributed Session
Adaptive designs for early-phase oncology trials of combined immunotherapy regimens

Session Details

Yuko Palesch
2015 (Arlington) Annual Meeting

Contributed Session
Adaptive first interim analysis design

Session Details

David Gillespie
2015 (Arlington) Annual Meeting

Contributed Session
ADHERENCE-ADJUSRED ESTIMATES OF BENEFITS AND HARMS FROM TREATMENT WITH AMOXICILLIN FOR LOWER-RESPIRATORY-TRACT-INFECTION: SECONDARY ANALYSIS OF A 12-COUNTRY RANDOMISED PLACEBO-CONTROLLED TRIAL USING RANDOMISATION-BASED EFFICACY ESTIMATORS

Session Details

Nariman Sepehrvand
2015 (Arlington) Annual Meeting

Contributed Session
Alignment of Site versus Adjudication Committee-based diagnoses with the patients’ outcome: Lessons learned from PROACT-3 trial

Session Details

Gillian Gresham
2015 (Arlington) Annual Meeting

Contributed Session
Alternative Approaches to the Analysis of Toxicities in Randomized Clinical Trials

Session Details

Marisa De Rosa
2015 (Arlington) Annual Meeting

Contributed Session
AN ONLINE DRUG REGISTRY EXPERIENCE IN ITALY TO SUPPORT MONITORING AND REIMBURSEMENT OF INNOVATIVE DRUGS

Session Details

Jason Stock
2015 (Arlington) Annual Meeting

Contributed Session
Applying DM Processes to Research Networks and How it Differs from “Traditional” Clinical Trials

Session Details

Dario Gregori
2015 (Arlington) Annual Meeting

Contributed Session
Assessing heterogeneity of treatment effect in case of unobserved covariates via conditional frailty models

Session Details

Heather Murray
2015 (Arlington) Annual Meeting

Contributed Session
Assessing impact on post-trial cardiovascular admissions, operations and procedures using routinely collected health records: Illustrated by the 20 year follow-up of the West of Scotland Coronary Prevention Study

Session Details

Sarah Leatherman
2015 (Arlington) Annual Meeting

Contributed Session
Assessing the Data Quality of a Clinical Trial Directly Embedded within the Electronic Medical Record: the Department of Veterans Affairs’ Point-of-Care Clinical Trial Experience

Session Details

Patsamon Rerksirikul
2015 (Arlington) Annual Meeting

Contributed Session
Association between Years of Clinical Trial Experience and Quality of Study data: Findings from HIV Research Centers in Thailand

Session Details

Stacey Slone
2015 (Arlington) Annual Meeting

Contributed Session
Automated Reminders Promote Completion of Long-Term Radon Tests in a Lung Cancer Study

Session Details

Renee Stewart
2015 (Arlington) Annual Meeting

Contributed Session
BARRIERS AND CHALLENGES TO PARTICIPANT RECRUITMENT IN A RANDOMIZED CONTROLLED TRIAL ON ADVANCED CANCER PATIENTS

Session Details

Deokumar Srivastava
2015 (Arlington) Annual Meeting

Contributed Session
Beyond the Assumption of Constant Hazard Rate in Estimating Incidence Rate on Current Status Data with Applications to Phase IV Cancer Trial

Session Details

Soe Soe Thwin
2015 (Arlington) Annual Meeting

Contributed Session
Biostatistical Considerations for VA Cooperative Study #590, “Double-Blind Placebo-Controlled Study of Lithium for Preventing Repeated Suicidal Self-Directed Violence in Patients with Depression or Bipolar Disorder”

Session Details

Kerry Avery
2015 (Arlington) Annual Meeting

Contributed Session
BLINDING IN SURGICAL TRIALS IS POSSIBLE: EXPERIENCES FROM THE ROMIO FEASIBILITY STUDY

Session Details

Catherine Dillon
2015 (Arlington) Annual Meeting

Contributed Session
Building a Strong Data Management Center for the National Institutes of Health’s Stroke Trials Network

Session Details

Steven Julious
2015 (Arlington) Annual Meeting

Contributed Session
Case Studies and Exemplars of Efficient Study Designs in Clinical Trials

Session Details

Paul Thompson
2015 (Arlington) Annual Meeting

Contributed Session
Causal analyses of randomized clinical trials improves understanding

Session Details

Todd MacKenzie
2015 (Arlington) Annual Meeting

Contributed Session
CAUSAL HAZARD RATIO ESTIMATION USING PRINCIPAL STRATIFICATION

Session Details

Trisha Boekhoudt
2015 (Arlington) Annual Meeting

Contributed Session
CHALLENGES IN DATA MANAGEMENT FOR CONSORTIA

Session Details

Lijuan Zeng
2015 (Arlington) Annual Meeting

Contributed Session
CHARACTERIZING REPORTING OF PHASE 3 CROSSOVER TRIALS REGISTERED ON CLINICALTRIALS.GOV

Session Details

Elizabeth Gargon
2015 (Arlington) Annual Meeting

Contributed Session
CHOOSING IMPORTANT HEALTH OUTCOMES FOR COMPARATIVE EFFECTIVENESS RESEARCH: A SYSTEMATIC REVIEW

Session Details

Abhinav Sharma
2015 (Arlington) Annual Meeting

Contributed Session
Clinical outcomes and biomarker expression patterns in diabetics with heart failure: novel insights from the COACH study

Session Details

Emily Dressler
2015 (Arlington) Annual Meeting

Contributed Session
Clinical trial interim strategies for rare even outcomes using Poisson distributions: Extension of Bayesian predictive probability designs

Session Details

Abigail Shoben
2015 (Arlington) Annual Meeting

Contributed Session
Consent bias in cluster randomized trials: Should we be concerned?

Session Details

Carol Van Huysen
2015 (Arlington) Annual Meeting

Contributed Session
Consideration and Early Barrier Assessment for use of Electronic Health Record Access for Remote Source Document Verification in a Clinical Trials Network

Session Details

Lauren Yesko
2015 (Arlington) Annual Meeting

Contributed Session
Creating a Comprehensive Clinical Trial Management System

Session Details

Shannon McDonough
2015 (Arlington) Annual Meeting

Contributed Session
CURRENT STATUS AND LESSONS LEARNED FROM THE IMPLEMENTATION OF THE SWOG LUNG MASTER PROTOCOL

Session Details

Elizabeth Wright
2015 (Arlington) Annual Meeting

Contributed Session
DATA AND SAMPLE REPOSITORIES – HOW ARE ARCHIVED DATA SETS BEING USED?

Session Details

Katelyn Garcia
2015 (Arlington) Annual Meeting

Contributed Session
DATA COLLECTION AND CLEANING FOR PARTICIPANT ENTERED MEDICATIONS: THE STUDY OF NOVEL APPROACHES TO PREVENTION CLINICAL TRIAL

Session Details

William Meurer
2015 (Arlington) Annual Meeting

Contributed Session
Department of Emergency Medicine; Department of Neurology, University of Michigan, Ann Arbor Overview

Session Details

Tracee Williams
2015 (Arlington) Annual Meeting

Contributed Session
DESIGN AND IMPLEMENTATION OF A DYNAMIC AND ELECTRONIC DELEGATION OF STUDY RESPONSIBILITIES AND SIGNATURE LOG

Session Details

Bryan Comstock
2015 (Arlington) Annual Meeting

Contributed Session
DESIGNING A RANDOMIZED CONTROLLED TRIAL WITH CONTINUOUS PATIENT REPORTED OUTCOMES USING A MINIMALLY CLINICALLY IMPORTANT RESPONSE DERIVED EFFECT SIZE

Session Details

Nicole Cockayne
2015 (Arlington) Annual Meeting

Contributed Session
DESIGNING AND IMPLEMENTING A RANDOMISED CONTROLLED TRIAL EVALUATING AN ADJUNCTIVE INTERNET-DELIVERED COGNITIVE BEHAVIOURAL THERAPY PROGRAM ON OUTCOMES OF STANDARD TREATMENT FOR DEPRESSION: UNIQUE CHALLENGES AND LESSONS LEARNED

Session Details

Amy Whitehead
2015 (Arlington) Annual Meeting

Contributed Session
Designing Randomised Controlled Trials based on Pilot Trials: Statistical Issues and Challenges

Session Details

Janice Pogue
2015 (Arlington) Annual Meeting

Contributed Session
Detecting unreported hospitalizations in a multi-national RCT: Looking for a needle in a haystack?

Session Details

David Gillespie
2015 (Arlington) Annual Meeting

Contributed Session
DETERMINING MAXIMAL INTERVENTION BENEFIT IN PUBLIC HEALTH TRIALS USING RANDOMISATION-BASED EFFICACY ESTIMATORS

Session Details

Lauren Yesko
2015 (Arlington) Annual Meeting

Contributed Session
Developing a Site Training and Troubleshooting Plan in the Digital Age

Session Details

Roberta Scherer
2015 (Arlington) Annual Meeting

Contributed Session
Developing the protocol for the standard-of-care treatment arm of the Tinnitus Retraining Therapy Trial

Session Details

Kerry Avery
2015 (Arlington) Annual Meeting

Contributed Session
DEVELOPMENT OF A CORE OUTCOME SET FOR TRIALS IN OESOPHAGEAL CANCER SURGERY

Session Details

Larisa Tereshchenko
2015 (Arlington) Annual Meeting

Contributed Session
Development of an arrhythmia patient council to improve patient engagement and patient centeredness in clinical cardiac electrophysiology research

Session Details

Mae Gordon
2015 (Arlington) Annual Meeting

Contributed Session
Diagnostic Misclassification: Possible Explanation for Unsuccessful Therapeutic Trials of 'Pink Eye’

Session Details

Mayumi Fukuda-Doi
2015 (Arlington) Annual Meeting

Contributed Session
DIFFERENCES IN REGULATORY SYSTEMS GOVERNING CLINICAL TRIALS- COMPARISON BETWEEN JAPAN AND US

Session Details

Munyaradzi Dimairo
2015 (Arlington) Annual Meeting

Contributed Session
Differential reporting of group sequential randomised controlled trials (GS RCT): shortcomings of the CONSORT 2010 statement

Session Details

Ravi Ramjeesingh
2015 (Arlington) Annual Meeting

Contributed Session
Disease Risk Scores: Use in a Retrospective Analysis Regarding Correlation between Time to Adjuvant Chemotherapy Treatment (TTAC) and Disease Outcomes in Early Breast Cancer.

Session Details

William Aitchison
2015 (Arlington) Annual Meeting

Contributed Session
EDC database driven rule based logic - benefits and potential

Session Details

Chengwu Yang
2015 (Arlington) Annual Meeting

Contributed Session
Effects of preterm delivery and early intervention on infants’ mental development: A randomized controlled two-year follow-up study

Session Details

Adelaide Doussau
2015 (Arlington) Annual Meeting

Contributed Session
Ethical tension in cancer randomized controlled trials using placebo: a review of recently published trials.

Session Details

Manoj Humagain
2015 (Arlington) Annual Meeting

Contributed Session
EVALUATION OF ASSOCIATION BETWEEN THE PREVALENCE AND SEVERITY OF PERIODONTAL DISEASES AND ABO BLOOD GROUPS AMONG NEPALESE ADULTS

Session Details

Zhaoyang Teng
2015 (Arlington) Annual Meeting

Contributed Session
Evaluation of Imposing an Additional Requirement and Sample Size Planning for Multi-Regional Clinical Trials.

Session Details

Katie Gillies
2015 (Arlington) Annual Meeting

Contributed Session
EvaLuation of Interventions for informed Consent for randomIsed controlled Trials (ELICIT): developing a core outcome set.

Session Details

Julia Brown
2015 (Arlington) Annual Meeting

Contributed Session
Experience and Benefits arising from The United Kingdom Registered Clinical Trials Unit Network : J Brown on behalf of the UKCRC Registered Clinical Trials Unit Executive

Session Details

Allan Hackshaw
2015 (Arlington) Annual Meeting

Contributed Session
Experience from a national randomized phase III trial to prospectively evaluate a predictive biomarker for chemotherapy, in patients with advanced non-small cell lung cancer

Session Details

Letitia Perdue
2015 (Arlington) Annual Meeting

Contributed Session
Form Design for Participant Data Entry: The Study of Novel Approaches to Prevention Clinical Trial

Session Details

Wen Wan
2015 (Arlington) Annual Meeting

Contributed Session
Graphic Illustration of Interaction Analysis of Three Combination Drugs via a Modified Genetic Algorithm

Session Details

Koko Asakura
2015 (Arlington) Annual Meeting

Contributed Session
Group-sequential strategies for clinical trials with co-primary endpoints

Session Details

Katharine Cooper-Arnold
2015 (Arlington) Annual Meeting

Contributed Session
HOW CAN CLINICAL TRIAL METRICS IMROVE PERFORMANCE AND FUNDER/GRANTEE COMMUNICATION: THE NIH PERSPECTIVE

Session Details

Kerry Avery
2015 (Arlington) Annual Meeting

Contributed Session
HOW CAN PILOT WORK OPTIMALLY INFORM SURGICAL RCTS? A REVIEW OF CURRENT EVIDENCE

Session Details

Katie Neville
2015 (Arlington) Annual Meeting

Contributed Session
HOW CAN WE DELIVER OPTIMUM BENEFITS FOR PATIENTS? MAXIMISING EFFICIENCY WITH A SEAMLESS PHASE II/III TRIAL DESIGN

Session Details

Alison McDonald
2015 (Arlington) Annual Meeting

Contributed Session
How can we improve the efficiency of trial conduct? Views of UK Clinical Trials Units staff

Session Details

Amy Mhatre-Owens
2015 (Arlington) Annual Meeting

Contributed Session
How To Prepare An Informative And Thorough DSMB Report

Session Details

Ian Saldanha
2015 (Arlington) Annual Meeting

Contributed Session
Impact of author conflicts of interest on full publication of RCTs presented at conferences

Session Details

Qiyuan Shi
2015 (Arlington) Annual Meeting

Contributed Session
IMPACT OF PUBLICATION BIAS ON NETWORK META-ANALYSIS: A NETWORK META-ANALYSIS OF PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION DRUGS USING AVAILABLE PUBLIC DATA FROM FDA CLINICAL REVIEWS

Session Details

Matthew Wright
2015 (Arlington) Annual Meeting

Contributed Session
IMPLEMENTATION OF A MEDICATION AND SUPPLY INVENTORY AND RESUPPLY PROCESS - INCREASING THE EFFICIENCY OF THE TRACKING AND DISTRIBUTION OF SUPPLIES IN CLINICAL TRIALS

Session Details

John Podoba
2015 (Arlington) Annual Meeting

Contributed Session
Implementation of a Web-based Minimization Algorithm for Patient Allocation in Clinical Trials

Session Details

Jaemyung Kim
2015 (Arlington) Annual Meeting

Contributed Session
Implementation of Advanced Randomization Algorithm with Integrated Study Drug Tracking

Session Details

Kenneth Schechtman
2015 (Arlington) Annual Meeting

Contributed Session
IMPROVED HEALTH THROUGH EFFICIENT WOOD BURNING COOKSTOVES IN RURAL INDIA: DESIGN OF A CLUSTER RANDOMIZED TRIAL

Session Details

Joerg Hasford
2015 (Arlington) Annual Meeting

Contributed Session
In multinational trials adverse reactions should be analysed by country or region too.

Session Details

Eric Foster
2015 (Arlington) Annual Meeting

Contributed Session
INCLUDING UNCERTAINTY IN THE TARGET PROBABILITY OF DOSE LIMITING TOXICITY IN PHASE I/II STUDIES WITH A DOSE FINDING COMPONENT

Session Details

Maiken Pontoppidan
2015 (Arlington) Annual Meeting

Contributed Session
INCREDIBLE YEARS PARENTS AND BABIES – A RANDOMIZED CONTROLLED TRIAL OF A PARENTING INTERVENTION IN DENMARK

Session Details

Kaleab Abebe
2015 (Arlington) Annual Meeting

Contributed Session
Informative Censoring in the HALT-PKD Study B Trial

Session Details

Zackary Lemka
2015 (Arlington) Annual Meeting

Contributed Session
Integrated Electronic Data Monitoring System for Multi-center Clinical Trials

Session Details

Erik Doffagne
2015 (Arlington) Annual Meeting

Contributed Session
Integrating Central Statistical Monitoring (CSM) in a Quality by Design (QbD) approach for Clinical Trials

Session Details

Sarah Brown
2015 (Arlington) Annual Meeting

Contributed Session
INTERIM SAMPLE SIZE RE-ESTIMATION: SAFEGUARDING THE POWER OF A TRIAL

Session Details

Valeriya Lockwood
2015 (Arlington) Annual Meeting

Contributed Session
INTERNATIONAL CLINICAL TRIALS: IMPLEMENTATION, COORDINATION, AND OBSTACLES

Session Details

Suzanne Hartley
2015 (Arlington) Annual Meeting

Contributed Session
Is dedication all you need to deliver to time and target in a multicentre study? Lessons learned from the UK Prevention of Delirium (POD) study

Session Details

Isabelle Smith
2015 (Arlington) Annual Meeting

Contributed Session
Is pain a predictor of Category 2 pressure ulcers? Comparison of methods used to analyse data from the PURPOSE Pain Cohort Study

Session Details

Jonathan Gibb
2015 (Arlington) Annual Meeting

Contributed Session
Laboratory Information Management Systems for academic trials with complex/multiple cohorts

Session Details

Niravath Polly
2015 (Arlington) Annual Meeting

Contributed Session
LESSONS LEARNED FROM ULTRA-SENSITIVE ESTRADIOL QUANTITATION

Session Details

Polly Niravath
2015 (Arlington) Annual Meeting

Contributed Session
LESSONS LEARNED FROM ULTRA-SENSITIVE ESTRADIOL QUANTITATION

Session Details

SETH OKEYO
2015 (Arlington) Annual Meeting

Contributed Session
MANAGING CLINICAL DATA QUERIES USING AN IN-HOUSE BUILT QUERY MANAGEMENT SYSTEM- QMSPlus

Session Details

Francesca Fiorentino
2015 (Arlington) Annual Meeting

Contributed Session
Managing multiple outcomes in early phase trials

Session Details

Lauren Yesko
2015 (Arlington) Annual Meeting

Contributed Session
Measuring Treatment Adherence and Exposure, and Study Completion

Session Details

Donald Taves
2015 (Arlington) Annual Meeting

Contributed Session
MINIMIZATION CAN PREVENT SELECTION BIAS

Session Details

Graeme MacLennan
2015 (Arlington) Annual Meeting

Contributed Session
Missing data in multi-item patient reported outcome measures: a case study using the the Oxford Knee Score

Session Details

Paola Berchialla
2015 (Arlington) Annual Meeting

Contributed Session
Modeling QoL in osteoarthritis as an RCT outcome using skewed truncated distributions

Session Details

James Moon
2015 (Arlington) Annual Meeting

Contributed Session
MONITORING ACCRUAL ON THE SWOG LUNG MASTER PROTOCOL

Session Details

Talat Almukhtar
2015 (Arlington) Annual Meeting

Contributed Session
MONITORING OF ADVERSE EVENTS REPORTING IN MULTICENTER CLINICAL TRIALS USING A MIXED EFFECT REGRESSION MODEL

Session Details

Monica Shah
2015 (Arlington) Annual Meeting

Contributed Session
NHLBI Heart Failure Network: Turning the Curve on Enrollment in Heart Failure Trials

Session Details

Chengwu Yang
2015 (Arlington) Annual Meeting

Contributed Session
On the relationship between the Modified Rankin Scale (mRS) and the NIH Stroke Scale (NIHSS)

Session Details

Jincheng Shen
2015 (Arlington) Annual Meeting

Contributed Session
Optimal Treatment Regime Estimation in Prostate Cancer Recurrence Management Using Random Forests

Session Details

Kerry Avery
2015 (Arlington) Annual Meeting

Contributed Session
OPTIMISING THE DESIGN OF INTERNAL PILOT WORK TO INFORM EFFICIENT RANDOMISED CONTROLLED TRIALS: ISSUES TO CONSIDER WHEN DEVELOPING PROGRESSION CRITERIA

Session Details

Kabir Soeny
2015 (Arlington) Annual Meeting

Contributed Session
Optimizing Dose Regimens and Fixed Dose Combination Ratios for a Target Concentration

Session Details

Lynda Constable
2015 (Arlington) Annual Meeting

Contributed Session
Overcoming a Trial ‘Adverse Event’: impact and experiences of a temporary suspension of a clinical trial

Session Details

Qian Shi
2015 (Arlington) Annual Meeting

Contributed Session
Performances of modified trial-level surrogacy estimates in binary-survival endpoint scenario

Session Details

Francesca Fiorentino
2015 (Arlington) Annual Meeting

Contributed Session
Pharmacological Interventions for the Prevention of Contrast Induced Nephropathy in High-Risk Adult Patients Undergoing Coronary Angiography: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.

Session Details

Karisse Torres
2015 (Arlington) Annual Meeting

Contributed Session
Presentation of the currentness of data in DMC reports – Learnings from a Randomized Control Trial with Infrequent Study Visit

Session Details

Jiang Yuan
2015 (Arlington) Annual Meeting

Contributed Session
Program-Wide DMCs Pros and Cons - the ISC point of view

Session Details

Joana Sederias
2015 (Arlington) Annual Meeting

Contributed Session
REDUCING ADVERSE EVENTS REPORTING FOR COMMERCIALLY AVAILABLE AGENTS (SUNITINIB AND TEMSIROLIMUS) CAN IMPROVE PHASE II TRIAL EXECUTION

Session Details

Nikki van Leeuwen
2015 (Arlington) Annual Meeting

Contributed Session
REGRESSION DISCONTINUITY DESIGN: SIMULATION AND APPLICATION IN THREE RANDOMIZED TRIALS WITH DICHOTOMOUS OUTCOMES

Session Details

Kseniia Ratushna
2015 (Arlington) Annual Meeting

Contributed Session
RESEARCH OF THE TRAINING LEVEL OF CLINICAL TRIAL SPECIALISTS USING THE SELF-ASSESSMENTS SYSTEMS

Session Details

Catherine Gregor
2015 (Arlington) Annual Meeting

Contributed Session
RESEARCHMATCH: AN ON-LINE REGISTRY TO CONNECT VOLUNTEERS AND CLINICAL RESEARCHERS

Session Details

Christina Yap
2015 (Arlington) Annual Meeting

Contributed Session
Response-Adaptive Randomization in Multi-Arm Selection Trials: Comparison of a Frequentist and Bayesian Approach

Session Details

Pradeep Singh
2015 (Arlington) Annual Meeting

Contributed Session
Robust multivariate test procedure for discrete and continuous outcome measures with application to pediatric cancer survivor study

Session Details

Ruitao LIN
2015 (Arlington) Annual Meeting

Contributed Session
Robust Optimal Interval Design with an Application to Dose Finding in Drug-Combination Trials

Session Details

Anne Daykin
2015 (Arlington) Annual Meeting

Contributed Session
ROLES AND DECISION MAKING OF TRIAL OVERSIGHT COMMITTEES AND THE CONTRIBUTION TO TRIAL CONDUCT: A QUALITATIVE STUDY.

Session Details

Toshimitsu Hamasaki
2015 (Arlington) Annual Meeting

Contributed Session
Sample size considerations for clinical trials with two primary time-to-event outcomes

Session Details

Kristian Brock
2015 (Arlington) Annual Meeting

Contributed Session
Seamless Phase I/II Adaptive Dose-finding Design with Efficacy-Toxicity Trade-offs for Targeted Therapies in Oncology

Session Details

MOISÉS GÓMEZ MATEU
2015 (Arlington) Annual Meeting

Contributed Session
SELECTING THE PRIMARY ENDPOINT IN A RANDOMIZED CLINICAL TRIAL. A CARDIOVASCULAR CASE STUDY

Session Details

Gaurav Sharma
2015 (Arlington) Annual Meeting

Contributed Session
Sensitivity Analysis for the Primary Outcome in a Drug Abuse Trial

Session Details

Lifeng Lin
2015 (Arlington) Annual Meeting

Contributed Session
Sensitivity to excluding treatments in network meta-analysis

Session Details

Karla Hemming
2015 (Arlington) Annual Meeting

Contributed Session
Setting straight the sample size determination for stepped wedge and cluster randomised trials: design effects and illustrative examples

Session Details

Aenne Glass
2015 (Arlington) Annual Meeting

Contributed Session
SMALL-ANIMAL PET/CT STUDY FOR COMPARISON OF PEPTIDE RADIOTRACER CHOLINE AND BOMBESIN FOR PROSTATA CANCER IMAGING IN A PC-3 HUMAN PROSTATE CANCER XENOGRAFT MOUSE MODEL

Session Details

Emily Miller
2015 (Arlington) Annual Meeting

Contributed Session
SOCIAL NETWORK ANALYSIS AND NETWORK MAPPING SHOW THE GROWTH OF COPUBLICATION NETWORKS ON THE ACTION FOR HEALTH IN DIABETES (LOOK AHEAD) CLINICAL TRIAL

Session Details

Zhibao Mi
2015 (Arlington) Annual Meeting

Contributed Session
Statistical Assessment of Rescue Medication Effect in Psychiatric Clinical Trials

Session Details

Mary Redman
2015 (Arlington) Annual Meeting

Contributed Session
Statistical Designs of Master Protocols and on the Design of the SWOG Lung Master Protocol(S1400; Lung-MAP)

Session Details

MARION CAMPBELL
2015 (Arlington) Annual Meeting

Contributed Session
STEPPED WEDGE DESIGNS OR STANDARD CLUSTER TRIAL DESIGNS FOR EVALUATING HEALTHCARE INTERVENTIONS?

Session Details

Lydia Foster
2015 (Arlington) Annual Meeting

Contributed Session
Stopping Early in a Non-Inferiority Trial When the Primary Efficacy Outcome is also the Primary Safety Outcome

Session Details

Nicole Butler
2015 (Arlington) Annual Meeting

Contributed Session
Streamlining Event Adjudication: Moving from a Paper-based to Web-based System

Session Details

Alexandra Stout
2015 (Arlington) Annual Meeting

Contributed Session
STREAMLINING PROTOCOL DESIGN: THE COST OF COMPLEXITY

Session Details

Dorothee Arenz
2015 (Arlington) Annual Meeting

Contributed Session
Strengthening Clinical Research through Institutionalized Clinical Conduct Management

Session Details

Wenle Zhao
2015 (Arlington) Annual Meeting

Contributed Session
Subject Randomization in Studies with Unequal Allocation

Session Details

Petra Schmalz
2015 (Arlington) Annual Meeting

Contributed Session
SUCCESSFUL ESTABLISHMENT OF CLINICAL RESEARCH STRUCTURES AT UNIVERSITY HOSPITAL COLOGNE BY PUBLIC FUNDING

Session Details

Chris Cook
2015 (Arlington) Annual Meeting

Contributed Session
TECHNICAL IMPLEMENTATION OF THE SWOG LUNG MASTER PROTOCOL (S1400; LUNG-MAP)

Session Details

Lee McDaniel
2015 (Arlington) Annual Meeting

Contributed Session
Testing Proportional and Additive Hazards Assumptions

Session Details

Dikla Blumberg
2015 (Arlington) Annual Meeting

Contributed Session
THE DEVELOPMENT OF A REAL-TIME PROTOCOL DEVIATION NOTIFICATION, TRACKING AND RESOLUTION PROCESS IN MULTI-SITE SUBSTANCE USE TREATMENT CLINICAL TRIALS

Session Details

Olympia Papachristofi
2015 (Arlington) Annual Meeting

Contributed Session
THE HUMAN FACTOR IN COMPLEX SURGICAL INTERVENTIONS: ASSESSING THE IMPACT OF SURGEON LEARNING CURVES.

Session Details

Rebecca Lewis
2015 (Arlington) Annual Meeting

Contributed Session
THE IMPACT OF A SURVEY CONDUCTED TO INFORM DEVELOPMENT OF A COMPLEX INTERVENTION TRIAL IN MUSCLE INVASIVE BLADDER CANCER (MIBC)

Session Details

Gillian Gresham
2015 (Arlington) Annual Meeting

Contributed Session
The Impact of Treatment Cycle on Protocol Completion in Randomized Clinical Trials

Session Details

Michelle Snape
2015 (Arlington) Annual Meeting

Contributed Session
THE IMPLEMENTATION AND UTILITY OF SCREENING LOGS IN A RANDOMISED CONTROLLED TRIAL OF PERI-OPERATIVE CHEMOTHERAPY OR SURVEILLANCE IN UPPER TRACT UROTHELIAL CANCER (POUT - CRUK/11/027)

Session Details

Zhiying You
2015 (Arlington) Annual Meeting

Contributed Session
The minimum required number of clusters with unequal cluster sizes in cluster randomized trials

Session Details

Eve Jelstrom
2015 (Arlington) Annual Meeting

Contributed Session
THE NATIONAL DRUG ABUSE TREATMENT CLINICAL TRIALS NETWORK (CTN) INVESTIGATOR TOOLBOX PROJECT: RESOURCES FOR CLINICAL TRIALS MANAGEMENT

Session Details

Eric Foster
2015 (Arlington) Annual Meeting

Contributed Session
THE NETWORK FOR EXCELLENCE IN NEUROSCIENCE CLINICAL TRIALS (NeuroNEXT) PROTOCOL WORKING GROUP DESIGN PHASE EXPERIENCES

Session Details

Amy Ruppert
2015 (Arlington) Annual Meeting

Contributed Session
The Relationship among Toxicity, Response, and Survival Profiles Ultimately Influence Calling a Beneficial Experimental Drug Favorable under Standard Phase I, II, and III Clinical Trial Designs

Session Details

Kevin Wilson
2015 (Arlington) Annual Meeting

Contributed Session
THE USE OF OPEN-SOURCE WEB-BASED TOOLS TO FACILITATE AND SUPPORT AN MRI IMAGING STUDY OF ANTERIOR VAGINAL WALL DESCENT IN WOMEN WITH PELVIC ORGAN PROLAPSE.

Session Details

James Martin
2015 (Arlington) Annual Meeting

Contributed Session
The use of simulation to examine the effects of varying cluster size on the power of stepped wedge cluster randomised trials

Session Details

Robbie Wilson
2015 (Arlington) Annual Meeting

Contributed Session
Timing is everything: Experience from Integrating Drug Supply Management (DSM) systems into eCRF systems.

Session Details

Aenne Glass
2015 (Arlington) Annual Meeting

Contributed Session
To improve the prediction of procedural success after aortic valve implantation: A pilot study (N=60) to identify unconventional, approach-related predictors

Session Details

Agnieshka Baumritter
2015 (Arlington) Annual Meeting

Contributed Session
TRAINING AND CERTIFICATION OF NON-PHYSICIANS FOR DETECTING REFERRAL-WARRANTED RETINOPATHY OF PREMATURITY IN THE TELEMEDICINE APPROACHES TO EVALUATING ACUTE-PHASE RETINOPATHY OF PREMATURITY (E-ROP) STUDY

Session Details

Athanasia Gravani
2015 (Arlington) Annual Meeting

Contributed Session
Training of staff within Randomized Controlled Trials (RCTs) of health-care interventions: a systematic review of the literature

Session Details

Jeannette Lee
2015 (Arlington) Annual Meeting

Contributed Session
TREATMENT OF MALE PARTNERS TO PREVENT RECURRENT BACTERIAL VAGINOSIS IN WOMEN

Session Details

Shelly Lensing
2015 (Arlington) Annual Meeting

Contributed Session
Two-Stage Phase II Design for Simultaneously Evaluating Efficacy and Toxicity of an Anti-Angiogenic Agent for Treating Kaposi Sarcoma

Session Details

Shelly Lensing
2015 (Arlington) Annual Meeting

Contributed Session
Two-Stage Phase II Design without Suspending Accrual for Interim Analysis

Session Details

Jenny Donovan
2015 (Arlington) Annual Meeting

Contributed Session
Understanding recruitment to randomized clinical trials: clear obstacles and hidden challenges for recruiters

Session Details

Olympia Papachristofi
2015 (Arlington) Annual Meeting

Contributed Session
UNRAVELLING THE COMPLEXITIES IN THE ASSESSMENT OF SURGICAL INTERVENTIONS: DECOMPOSING THE COMPLEX STRUCTURE AND ACCOUNTING FOR MULTIPLE PROVIDERS.

Session Details

Leah Forman
2015 (Arlington) Annual Meeting

Contributed Session
USE OF AN ANDROID PHONE APP FOR AUTOMATED TEXT MESSAGING IN INTERNATIONAL SETTINGS

Session Details

Sohail Mulla
2015 (Arlington) Annual Meeting

Contributed Session
Use of core outcome domains among chronic pain clinical trials

Session Details

Carley Prynn
2015 (Arlington) Annual Meeting

Contributed Session
Use of Internet Technology for Training, Certification, and Monitoring in the Gulf Long-Term Follow-up Study (GuLF STUDY)

Session Details

Sharon Kean
2015 (Arlington) Annual Meeting

Contributed Session
Using routinely collected datasets (primary and secondary care) for multi-centre clinical trials

Session Details

Matthew Curry
2015 (Arlington) Annual Meeting

Contributed Session
Utility of a Participant Survey to Assess the Feasibility of a Follow-up Clinical Exam in the Gulf Long-Term Follow-up STUDY (GuLF STUDY)

Session Details

Elizabeth Sugar
2015 (Arlington) Annual Meeting

Contributed Session
Utilizing Clinical Trials to Assess Cost-Effectiveness: Lessons from the MUST Trial

Session Details

Ira Katz
2015 (Arlington) Annual Meeting

Contributed Session
VA Cooperative Study # 590: Double-Blind Placebo-Controlled Study of Lithium for Preventing Repeated Suicidal Self-Directed Violence in Patients with Depression or Bipolar Disorder

Session Details

Anil Kumar
2015 (Arlington) Annual Meeting

Contributed Session
WEBREPORTER - An Automated Solution for Clinical Trials Web Reporting

Session Details

Jonathan Shtaynberger
2015 (Arlington) Annual Meeting

Contributed Session
What is the most popular dose-finding design for phase I oncology trials?

Session Details

Benjamin Rouse
2015 (Arlington) Annual Meeting

Contributed Session
WOULD NETWORK META-ANALYSIS HAVE CHANGED CLINICAL PRACTICE GUIDELINE RECOMMENDATIONS? A CASE STUDY ON FIRST-LINE MEDICAL THERAPIES FOR PRIMARY OPEN-ANGLE GLAUCOMA

Session Details

Christopher P. Austin
2014 (Philadelphia) Annual Meeting

Founders Lecture
The National Center for Advancing Translational Sciences: Catalyzing Translational Innovation

Daumit et al
2014 (Philadelphia) Annual Meeting

Trial of the Year Award
The Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE)

Sargent/Goodman
2014 (Philadelphia) Annual Meeting

Special Presentation
Recognition - Steve Goodman, Clinical Trials Journal Editor 2004-2013

Peter Peduzzi
2014 (Philadelphia) Annual Meeting

Fellows Presentation
Presentation of the Class of 2014 Fellows

Dan Sargent
2014 (Philadelphia) Annual Meeting

Presidential Welcome

Ezekiel J. Emanuel
2014 (Philadelphia) Annual Meeting

Curtis Meinert Lecture
Health Care Reform and the Future of Clinical Research

Ainy Zahid
2014 (Philadelphia) Annual Meeting

Contributed Session
‘Special Cases’ Tracking and Management

Session Details

Tsedenia Bezabeh
2014 (Philadelphia) Annual Meeting

Contributed Session
7 Steps to Edit Heaven: An Automated Workflow for Data Edit Implementation in Multicenter Clinical Trials

Session Details

Kit Howard
2014 (Philadelphia) Annual Meeting

Contributed Session
A Brave New World: CDISC’s New Therapeutic Areas Standards for Clinical Research

Session Details

Borko Jovanovic
2014 (Philadelphia) Annual Meeting

Contributed Session
A Clinical Trials Course in Master of Science in Clinical Investigations Program for Physician-Scientists: A Three Year Experience

Session Details

joy esterlitz
2014 (Philadelphia) Annual Meeting

Contributed Session
A Common Data Language for Clinical Research Studies: The National Institute of Neurological Disorders and Stroke (NINDS) Common Data Elements (CDE)

Session Details

Sungjin Kim
2014 (Philadelphia) Annual Meeting

Contributed Session
A Comparative Study of the Utilization of a Normalized Equivalent Toxicity Score (NETS) System to Fully Incorporate All Toxicities in Common Phase I Clinical Trial Designs

Session Details

Jessica Lavery
2014 (Philadelphia) Annual Meeting

Contributed Session
A COMPARISON OF MISSING DATA METHODS IN TYPE I DIABETES CLINICAL TRIALS

Session Details

Catherine Dillon
2014 (Philadelphia) Annual Meeting

Contributed Session
A Comparison of the Effectiveness of On-site and Central Monitoring Activities Across Five Phase III Multi-center Clinical Trials

Session Details

Heather Eng
2014 (Philadelphia) Annual Meeting

Contributed Session
A COMPREHENSIVE AUTOMATED DATA MANAGEMENT SYSTEM USING SAS® SOFTWARE

Session Details

Muhammad Iftakhar Alam
2014 (Philadelphia) Annual Meeting

Contributed Session
A Constrained Optimum Adaptive Design for Dose Finding in Early Phase Clinical Trials

Session Details

Haema Nilakanta
2014 (Philadelphia) Annual Meeting

Contributed Session
A Follow-Up: Meeting the Demands of Revolutionizing Research at Coordinating Centers, a focus on communication and training

Session Details

Aquila Farrell
2014 (Philadelphia) Annual Meeting

Contributed Session
A Manual of Procedures for an International Multi-Centre Academic Medical Device Trial

Session Details

Daniel Bratton
2014 (Philadelphia) Annual Meeting

Contributed Session
A multi-arm multi-stage clinical trial design for binary outcomes with application to tuberculosis

Session Details

Yunling Xu
2014 (Philadelphia) Annual Meeting

Contributed Session
A Note on Test for Non-inferiority on a Left Truncated Normal Endpoint

Session Details

Anne Daykin
2014 (Philadelphia) Annual Meeting

Contributed Session
A QUALITATIVE STUDY OF GROUP DECISION MAKING AND MEMBER ROLES TO UNDERSTAND AND IMPROVE HOW TRIAL OVERSIGHT COMMITTEES CONTRIBUTE TO TRIAL CONDUCT.

Session Details

Arzu Onar-Thomas
2014 (Philadelphia) Annual Meeting

Contributed Session
A Single Arm Efficacy Design Based on Comparison to a Set of Historical Control Trials in the Context of a Rare Pediatric Brain Tumor

Session Details

Kaitie Fernandez
2014 (Philadelphia) Annual Meeting

Contributed Session
A Suite of Statistical Data Checks to Identify Suspicious Data in a Central Data Management System

Session Details

Sohail Mulla
2014 (Philadelphia) Annual Meeting

Contributed Session
A web-based survey of clinical trialists’ views on allocation concealment methods in randomized trials

Session Details

Neil Corrigan
2014 (Philadelphia) Annual Meeting

Contributed Session
Accounting for clustering of patient outcomes when designing individually-randomised surgical trials

Session Details

Rick Morrison
2014 (Philadelphia) Annual Meeting

Contributed Session
Achieving Real-time Data Insights through the Cloud

Session Details

Laura Ferandes
2014 (Philadelphia) Annual Meeting

Contributed Session
Adaptive Clinical Trial Design

Session Details

Russell Reeve
2014 (Philadelphia) Annual Meeting

Contributed Session
Adaptive Dose-Response Trials: Are they More Efficient Than Fixed Designs?

Session Details

Laura Fernandes
2014 (Philadelphia) Annual Meeting

Contributed Session
Adaptive Phase I Clinical Trial Design Using Markov Models for Conditional Probability of Toxicity in Oncology.

Session Details

Wei Wang
2014 (Philadelphia) Annual Meeting

Contributed Session
Addressing Challenges of DMC for Small Companies and Clinical Research Organizations

Session Details

Valerie Henderson
2014 (Philadelphia) Annual Meeting

Contributed Session
Addressing Threats to Clinical Generalizability in Preclinical Experiments: A Feasibility Study of Sunitinib

Session Details

Wasana Prasitsuebsai
2014 (Philadelphia) Annual Meeting

Contributed Session
Adherence to CONSORT statements in publications of HIV randomized clinical trials from Asia

Session Details

Dal-Seok Oh
2014 (Philadelphia) Annual Meeting

Contributed Session
Age-adjusted reference values could be used for screening healthy older people in clinical trials

Session Details

Daniele De Martini
2014 (Philadelphia) Annual Meeting

Contributed Session
Allocating resources in Phase II and III Trials to Optimize Gain

Session Details

Jessica Stortz
2014 (Philadelphia) Annual Meeting

Contributed Session
AN ACADEMIC CLINICAL RESEARCH COORDINATING CENTRE’S PREPARATIONS FOR CONDUCTING SITE INITIATION VISITS IN A REGULATED CLINICAL TRIAL

Session Details

Malahat Khaula
2014 (Philadelphia) Annual Meeting

Contributed Session
AN ACADEMIC COORDINATING CENTRE’S EXPERIENCE IN DEVELOPING A STANDARD OPERATING PROCEDURE FOR THE ICF REVIEW AND APPROVAL PROCESS

Session Details

Kanae Takahashi
2014 (Philadelphia) Annual Meeting

Contributed Session
An e-mail based system for patient registration and treatment randomization with the application to a real randomized controlled trial

Session Details

Susan Reamer
2014 (Philadelphia) Annual Meeting

Contributed Session
Applying Acceptance Sampling, Risk-Based Monitoring, and Paperless Support to Improve Effectiveness in Data Audit Visits

Session Details

Rachel Currie
2014 (Philadelphia) Annual Meeting

Contributed Session
Applying Drug Clinical Trial Simulations to Devices: A Regulatory Policy and Feasibility Analysis

Session Details

Marianne Kearney
2014 (Philadelphia) Annual Meeting

Contributed Session
Assessment of Site Feasibility: The NeuroNEXT Network Experience

Session Details

William Meurer
2014 (Philadelphia) Annual Meeting

Contributed Session
Attitudes and Opinions Regarding Confirmatory Adaptive Clinical Trials: A Mixed Methods Analysis from the ADAPT-IT Project

Session Details

Jonathan Dukes
2014 (Philadelphia) Annual Meeting

Contributed Session
Automation of Data Cleaning Reports from the Research Electronic Data Capture System (REDCap

Session Details

Geng Chen
2014 (Philadelphia) Annual Meeting

Contributed Session
Bayesian inference for multivariate longitudinal data analysis using robust distributions

Session Details

Elizabeth Avery
2014 (Philadelphia) Annual Meeting

Contributed Session
Behavioral Clinical Trials Data Management: Challenges and Lessons Learned

Session Details

Wenle Zhao
2014 (Philadelphia) Annual Meeting

Contributed Session
Benefit of response adaptive randomization in confirmative clinical trials could be non-existent

Session Details

Kevin Wilson
2014 (Philadelphia) Annual Meeting

Contributed Session
Best Practices and Lessons Learned in Transitioning a Large Data Coordinating Center.

Session Details

Caitlyn Ellerbe
2014 (Philadelphia) Annual Meeting

Contributed Session
Bias Correction and Optimized Patient Allocation for Seamless Adaptive Dose Selection Design with Repeated Measures

Session Details

Marisa De Rosa
2014 (Philadelphia) Annual Meeting

Contributed Session
Big File Client: Cloud medical Images Exchange for Image-based Clinical Trials

Session Details

Ryan Bailey
2014 (Philadelphia) Annual Meeting

Contributed Session
BRIDGING THE TRANSLATIONAL RESEARCH DIVIDE: WHAT HAPPENS WHEN CLINICAL TRIALS MEET THE REAL WORLD

Session Details

Yuko Palesch
2014 (Philadelphia) Annual Meeting

Contributed Session
Caution! Approaching Interim Analysis

Session Details

Jane Hongyuan Zhang
2014 (Philadelphia) Annual Meeting

Contributed Session
Censoring or Competing Risks – Evaluation of Renal Function in VA NEPHRON-D Trial

Session Details

Janice Pogue
2014 (Philadelphia) Annual Meeting

Contributed Session
Central Statistical Data Monitoring: Can distance metrics of baseline characteristics be used to identify sites with inclusion/exclusion protocol violations?

Session Details

Kenneth Wilkins
2014 (Philadelphia) Annual Meeting

Contributed Session
Challenges in assessing journal authors' awareness of emerging standards for handling missing data, with illustrations from a focused review of Hepatitis C trials

Session Details

Colin Everett
2014 (Philadelphia) Annual Meeting

Contributed Session
Challenges in design and analysis of studies to evaluate diagnostic tests

Session Details

Helle Hansen
2014 (Philadelphia) Annual Meeting

Contributed Session
Challenges when recruiting to a randomized controlled trail of Parenting Prevention Programs in Denmark

Session Details

Ian Saldanha
2014 (Philadelphia) Annual Meeting

Contributed Session
Choosing the best outcomes when designing clinical trials: A case study using Cochrane reviews addressing HIV/AIDS

Session Details

Marisa De Rosa
2014 (Philadelphia) Annual Meeting

Contributed Session
Clinical Research Process Management System: how to improve the overall efficiency and control of the whole clinical research process

Session Details

lanju zhang
2014 (Philadelphia) Annual Meeting

Contributed Session
Clinical trial design strategies to adapt to the changing Payer Evidence Generation Paradigm

Session Details

Elizabeth Paynter
2014 (Philadelphia) Annual Meeting

Contributed Session
ClinicalTrials.gov Results Development and Management: A Successful Approach

Session Details

Charity Moore
2014 (Philadelphia) Annual Meeting

Contributed Session
Closeout of the HALT-Polycystic Kidney Disease Clinical Trials

Session Details

Jeff Sloan
2014 (Philadelphia) Annual Meeting

Contributed Session
COMBINING SURVIVAL AND TOXICITY EFFECT SIZES FROM CLINICAL TRIALS INTO AN INTERPRETABLE QUALITY-ADJUSTED SURVIVAL EFFECT SIZE ESTIMATE OF TREATMENT EFFICACY

Session Details

Jenny Tseng
2014 (Philadelphia) Annual Meeting

Contributed Session
Common Issues and Guidelines in Adverse Event Reporting

Session Details

Elizabeth Wright
2014 (Philadelphia) Annual Meeting

Contributed Session
Completeness and Accuracy of Protocol Descriptors for Trials of Treatments for Hepatitis C

Session Details

Rebecca Mister
2014 (Philadelphia) Annual Meeting

Contributed Session
Compliance to treatment in clinical trials using widely available medications: the ASPIRE experience

Session Details

Suzanne Breeman
2014 (Philadelphia) Annual Meeting

Contributed Session
COMPREHENSIVE COHORT STUDIES: CHALLENGES AND IMPLICATIONS

Session Details

Joe Rausch
2014 (Philadelphia) Annual Meeting

Contributed Session
Conceptualizing and Modeling Treatment Compliance in Randomized Clinical Trials

Session Details

Dennis Sweitzer
2014 (Philadelphia) Annual Meeting

Contributed Session
Construction and Validation of Markov Chain simulations of multiphase clinical studies using blinded operational data.

Session Details

Inna Perevozskaya
2014 (Philadelphia) Annual Meeting

Contributed Session
Continual Reassessment Method for a First-In-Human Trial: From Design to Trial Implementation

Session Details

Nolan Wages
2014 (Philadelphia) Annual Meeting

Contributed Session
Continual reassessment method for phase I oncology trials of combined drugs

Session Details

Jody Ciolino
2014 (Philadelphia) Annual Meeting

Contributed Session
Continuous Covariate Imbalance and Conditional Power for Clinical Trial Interim Analyses

Session Details

Marianne Kearney
2014 (Philadelphia) Annual Meeting

Contributed Session
Coordinating Center Support Required for an Academic Central IRB: The NeuroNEXT Network Experience

Session Details

Ashley Hogan
2014 (Philadelphia) Annual Meeting

Contributed Session
COORDINATING MEDICATION ASSIGNMENT AND DISTRIBUTION IN A MULTI-CENTER, PARTIALLY-BLINDED CLINICAL TRIAL

Session Details

william elgie
2014 (Philadelphia) Annual Meeting

Contributed Session
Creation of a serious adverse event (SAE) entry, reporting, tracking and notification system

Session Details

Carla D'Aveta
2014 (Philadelphia) Annual Meeting

Contributed Session
Creative Coordination: The best things in life are free

Session Details

Sherrie Whisler
2014 (Philadelphia) Annual Meeting

Contributed Session
Data Diamond Registry – A Population Management System

Session Details

Mae Gordon
2014 (Philadelphia) Annual Meeting

Contributed Session
Data Sharing: Important Unfunded Mandate

Session Details

Katie Gillies
2014 (Philadelphia) Annual Meeting

Contributed Session
Decision Aids to support the informed consent process for Randomised Controlled Trials.

Session Details

Natalie Blencowe
2014 (Philadelphia) Annual Meeting

Contributed Session
Descriptions of surgical interventions in RCTs: is there room for improvement?

Session Details

Fang Xia
2014 (Philadelphia) Annual Meeting

Contributed Session
Design of Cancer Clinical Trials for Jointly Assessing Progression-free Survival and Overall Survival

Session Details

Toshimitsu Hamasaki
2014 (Philadelphia) Annual Meeting

Contributed Session
Designing and monitoring group-sequential clinical trials with multiple co-primary endpoints

Session Details

Seonaidh Cotton
2014 (Philadelphia) Annual Meeting

Contributed Session
Developing an instrument to assess behavioural recovery following treatments for varicose veins

Session Details

Ryan Colvin
2014 (Philadelphia) Annual Meeting

Contributed Session
Development of a biospecimen tracking database: experiences in a clinical department

Session Details

Angus McNair
2014 (Philadelphia) Annual Meeting

Contributed Session
Development of a core outcome set for trials in colorectal cancer surgery

Session Details

Edvin Music
2014 (Philadelphia) Annual Meeting

Contributed Session
Development of Technology Infrastructure to Support Ecological Momentary Assessments in Clinical Research

Session Details

Alice Sheffet
2014 (Philadelphia) Annual Meeting

Contributed Session
Diversity in a Large Randomized Clinical Trial: Recruitment and Retention of Racial and Ethnic Minorities in the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST)

Session Details

Claudine Jennings
2014 (Philadelphia) Annual Meeting

Contributed Session
DOES PAYING PATIENTS TO PARTICIPATE IN RESEARCH IMPROVE RECRUITMENT AND INCREASE THE PROPORTION OF SOCIALLY DEPRIVED AND ELDERLY PARTICIPANTS?

Session Details

Trevis Huff
2014 (Philadelphia) Annual Meeting

Contributed Session
Drug Dispensing through the EDC in a Weight-Based, Titration, Maintenance, and Weaning Double-Blinded Drug Trial

Session Details

Brittny Major
2014 (Philadelphia) Annual Meeting

Contributed Session
EFFECT SIZES FOR PHASE II AND PHASE III ONCOLOGY CLINICAL TRIALS USING THE ½ STANDARD DEVIATION RULE

Session Details

Alexandra Stout
2014 (Philadelphia) Annual Meeting

Contributed Session
Effective Site Management Under a Risk-based Monitoring Plan

Session Details

Dorothee Arenz
2014 (Philadelphia) Annual Meeting

Contributed Session
Embedding Clinical Research into Standard of Care – A Qualifying Program for Clinical Trial Units

Session Details

Shaun Treweek
2014 (Philadelphia) Annual Meeting

Contributed Session
Engaging hard-to reach trial populations: lessons from the Football Fans in Training (FFIT ) trial.

Session Details

Olympia Papachristofi
2014 (Philadelphia) Annual Meeting

Contributed Session
ENHANCEMENT OF AN IDEAL FRAMEWORK FOR THE ASSESSMENT OF SURGICAL INTERVENTIONS: UNDERSTANDING THE COMPLEXITIES AND CONSTRUCTING SOLUTIONS

Session Details

Agnieshka Baumritter
2014 (Philadelphia) Annual Meeting

Contributed Session
Ensuring Successful Enrollment of Premature Babies into NICU based Clinical Studies: Lessons learned from the “Telemedicine Approaches to Evaluating Acute-phase retinopathy of prematurity (ROP) – e-ROP” Study

Session Details

Meredith Warshaw
2014 (Philadelphia) Annual Meeting

Contributed Session
Equipoise is in the eye of the beholder: Issues in clinical trial design and implementation when there are regional differences in perceived equipoise

Session Details

Qing Xu
2014 (Philadelphia) Annual Meeting

Contributed Session
Erythropoietic Response to the ESA Treatment and Outcomes in Non-Dialysis Patients with Chronic Kidney Disease

Session Details

Lynda Constable
2014 (Philadelphia) Annual Meeting

Contributed Session
Essentials of clinical trial management: effective study and site specific training

Session Details

Keiichi Yamamoto
2014 (Philadelphia) Annual Meeting

Contributed Session
Establishing a resilient clinical research infrastructure to protect information leakage: a four-tier in-hospital network for clinical research.

Session Details

Brittany Schwefel
2014 (Philadelphia) Annual Meeting

Contributed Session
Estimating the survival time to a composite outcome in the case of non-monotone, delayed event ascertainment

Session Details

Jincheng Shen
2014 (Philadelphia) Annual Meeting

Contributed Session
Estimation of the Optimal Regime in Treatment of Prostate Cancer Recurrence using Flexible Weighting Models

Session Details

rui tang
2014 (Philadelphia) Annual Meeting

Contributed Session
Evaluate Biomarker Effects on Survival with Nonparametric Predictiveness Curves (NPC)

Session Details

Gillian Gresham
2014 (Philadelphia) Annual Meeting

Contributed Session
Evaluating the efficiency and accuracy of data abstraction for systematic reviews using Systematic Review Data Repository

Session Details

J Athene Lane
2014 (Philadelphia) Annual Meeting

Contributed Session
EVALUATION OF SOURCE DATA VERIFICATION IN A MULTICENTRE CANCER TRIAL (PROTECT)

Session Details

Amber Salter
2014 (Philadelphia) Annual Meeting

Contributed Session
Evaluation of the time-to-event continual reassessment method in the presence of patient heterogeneity

Session Details

Gabriele Dreier
2014 (Philadelphia) Annual Meeting

Contributed Session
EVIDENCE-BASED RESEARCH AND HEALTH CARE: CO-OPERATION BETWEEN MEDICAL ASSOCIATIONS/MEDICAL SOCIETIES, THE GERMAN COCHRANE CENTER, A WHO CLINICAL TRIAL REGISTRY AND CLINICAL TRIAL UNITS. A CASE REPORT FROM GERMANY

Session Details

Robin Bechhofer
2014 (Philadelphia) Annual Meeting

Contributed Session
Evolution of a Data Monitoring Report in Response to Concerns about Potential Hepatotoxicity

Session Details

Renee Rees
2014 (Philadelphia) Annual Meeting

Contributed Session
Exception from Informed Consent in FDA/CBER Clinical Trials

Session Details

J. Johanna Sanchez
2014 (Philadelphia) Annual Meeting

Contributed Session
Expanding Research Beyond the Sponsoring Country: Special Considerations

Session Details

Jane Blazeby
2014 (Philadelphia) Annual Meeting

Contributed Session
Exploring Methods of Evidence Based Patient Reported Outcome Selection for Core Outcome Sets for Trials

Session Details

Spencer Hey
2014 (Philadelphia) Annual Meeting

Contributed Session
Extending Component Analysis: Ethical Considerations of Study Design and Study Context

Session Details

Chengwu Yang
2014 (Philadelphia) Annual Meeting

Contributed Session
FIX THE LEFT SIDE OF AN EQUATION: HOW TO RESCUE POSITIVE FINDINGS FROM A CLINICAL TRIAL THAT USED SCALES IF THEY WERE WRONG? ---- ILLUSTRATION WITH AN EXAMPLE

Session Details

Ivana Holloway
2014 (Philadelphia) Annual Meeting

Contributed Session
From RAGs (Red-Amber-Green) to riches: Site Achievement Report - an efficient way to provide feedback to improve sites’ performance

Session Details

Paul Thompson
2014 (Philadelphia) Annual Meeting

Contributed Session
General methods for power calculation

Session Details

Indu Shrivastava
2014 (Philadelphia) Annual Meeting

Contributed Session
GLOBAL CONTRIBUTION: CORRELATION BETWEEN EDUCATION IMPARTED AND QUALITY OF TRIALS CONDUCTED

Session Details

Zhibao Mi
2014 (Philadelphia) Annual Meeting

Contributed Session
Global Hypothesis Testing in Adverse Effect Assessment

Session Details

Claire Cochran
2014 (Philadelphia) Annual Meeting

Contributed Session
Good practice or waste of time? A trial manager’s perspective of 10% data entry checking within an international multicentre trial using electronic web based data capture.

Session Details

George Obsekov
2014 (Philadelphia) Annual Meeting

Contributed Session
How to Design Clinical Protocol for Randomized Controlled Trial

Session Details

John Podoba
2014 (Philadelphia) Annual Meeting

Contributed Session
HYBRID WEB / OFFLINE ELECTRONIC DATA CAPTURE FOR CLINICAL TRAILS: MANAGING OFFLINE DATA COLLECTION IN REGIONS WITH POOR OR LIMITED INTERNET CONNECTIVITY WHILE MAINTAINING THE BENEFITS OF A WEB-BASED ELECTRONIC DATA CAPTURE SYSTEM

Session Details

Tim Morris
2014 (Philadelphia) Annual Meeting

Contributed Session
Identifying relevant sensitivity analyses in clinical trials

Session Details

Liqiong Fan
2014 (Philadelphia) Annual Meeting

Contributed Session
Impact of covariate misclassification on the power and type I error in clinical trials using covariate-adaptive randomization

Session Details

Avie-Lee Tillotson
2014 (Philadelphia) Annual Meeting

Contributed Session
Implications of Changing Eligibility Criteria

Session Details

Colleen Allen
2014 (Philadelphia) Annual Meeting

Contributed Session
Implications of Modifying Study Eligibility Criteria Post-Initiation of Recruitment

Session Details

Liza Dawson
2014 (Philadelphia) Annual Meeting

Contributed Session
Inclusion of pregnant women and women of reproductive potential in clinical trials: ethical and scientific considerations

Session Details

Ming-Wen An
2014 (Philadelphia) Annual Meeting

Contributed Session
Incorporating the direct assignment option design into broader design frameworks

Session Details

Thidarat Jupimai
2014 (Philadelphia) Annual Meeting

Contributed Session
Institutional Review Board Submission Turnaround Time in an HIV Research Center in Bangkok, Thailand

Session Details

John Kloke
2014 (Philadelphia) Annual Meeting

Contributed Session
Interactive Graphics for Adverse Events in Safety Monitoring

Session Details

Sarah Titus
2014 (Philadelphia) Annual Meeting

Contributed Session
Investigation of a Three STAGE Adaptive Design Clinical Trial

Session Details

Francesca Fiorentino
2014 (Philadelphia) Annual Meeting

Contributed Session
Late improvements to the conduct and reporting of a randomised controlled trial

Session Details

Carole Federico
2014 (Philadelphia) Annual Meeting

Contributed Session
Late, Never, or Nonexistent: The Inaccessibility of Preclinical Evidence for New Drugs

Session Details

Karen Updyke
2014 (Philadelphia) Annual Meeting

Contributed Session
Lessons Learned in 3 Phase III Multi-Center Clinical Trial Database Locks

Session Details

Cathy Yang
2014 (Philadelphia) Annual Meeting

Contributed Session
Lessons Learned: Implementing an EDC System at a Data Coordinating Centre

Session Details

Elizabeth Colantuoni
2014 (Philadelphia) Annual Meeting

Contributed Session
Leveraging Prognostic Baseline Variables to Gain Precision in Randomized Trials

Session Details

Adam Mendizabal
2014 (Philadelphia) Annual Meeting

Contributed Session
Leveraging Resources to Design, Conduct and Analyze Hematopoietic Stem Cell Transplant Clinical Trials: The Ongoing Collaboration between the Center for International Blood and Marrow Transplant Research and the Blood and Marrow Transplant Clinical Trials Network

Session Details

Katie Gillies
2014 (Philadelphia) Annual Meeting

Contributed Session
Making a decision about trial participation: measuring deliberation during the informed consent process.

Session Details

Natalie Blencowe
2014 (Philadelphia) Annual Meeting

Contributed Session
Making sense of RCTs in surgery: new methods for intervention description and monitoring in trials

Session Details

Jeffrey Martin
2014 (Philadelphia) Annual Meeting

Contributed Session
Managing Enrollments Tracking System: A smart tool for ensuring recruitment goals

Session Details

Natalie Blencowe
2014 (Philadelphia) Annual Meeting

Contributed Session
Methods for describing and accounting for surgical expertise within RCTs: a systematic review

Session Details

Alexandra Wright-Hughes
2014 (Philadelphia) Annual Meeting

Contributed Session
METHODS TO ASSESS CONCORDANCE IN WOUND SAMPLING

Session Details

Jo Ann Hartline
2014 (Philadelphia) Annual Meeting

Contributed Session
Mixed Mode Follow-up for an Aging Study Population

Session Details

Barbara Braffett
2014 (Philadelphia) Annual Meeting

Contributed Session
MODERNIZING A LONGITUDINAL FOLLOW-UP STUDY AFTER 30 YEARS OF DATA COLLECTION

Session Details

Ryan Bailey
2014 (Philadelphia) Annual Meeting

Contributed Session
Monitoring Adverse Events using an Interactive Web-Based Tool

Session Details

Letitia Perdue
2014 (Philadelphia) Annual Meeting

Contributed Session
MONITORING DATA COMPLETENESS OF PARTICIPANT DATA ENTRY: THE STUDY OF NOVEL APPROACHES TO PREVENTION CLINICAL TRIAL

Session Details

Supalak Phonphithak
2014 (Philadelphia) Annual Meeting

Contributed Session
Monitoring findings and quality management at a HIV-research center in Bangkok, Thailand

Session Details

Lauren Yesko
2014 (Philadelphia) Annual Meeting

Contributed Session
MONITORING MEDICATION ADHERENCE ELECTRONICALLY: CONSIDERATIONS AND A CASE STUDY

Session Details

Gregg Gilbert
2014 (Philadelphia) Annual Meeting

Contributed Session
NINE YEARS OF LESSONS LEARNED FROM STUDIES IN THE NATIONAL DENTAL PRACTICE-BASED RESEARCH NETWORK

Session Details

Graeme MacLennan
2014 (Philadelphia) Annual Meeting

Contributed Session
Non-compliance with randomised allocation and missing primary outcome data in randomised controlled trials evaluating surgical interventions: a systematic review

Session Details

Jarcy Zee
2014 (Philadelphia) Annual Meeting

Contributed Session
Nonparametric Discrete Survival Function Estimation in the Presence of Uncertain Event Indicators by Using an Internal Validation Subsample

Session Details

Kathryn Blake
2014 (Philadelphia) Annual Meeting

Contributed Session
Novel Study Design Using iPads and the Internet in an Asthma Clinical Trial

Session Details

yong zang
2014 (Philadelphia) Annual Meeting

Contributed Session
Optimal Marker-strategy Clinical Trial Design to Detect Predictive Markers for Targeted Therapy

Session Details

Lauren Yesko
2014 (Philadelphia) Annual Meeting

Contributed Session
Optimizing an Existing Data Collection System for Tablet Compatibility: Considerations and a Case Study

Session Details

Kabir Soeny
2014 (Philadelphia) Annual Meeting

Contributed Session
Optimizing Dose Regimens and Fixed Dose Combination Ratios in Clinical Trials

Session Details

Dario Gregori
2014 (Philadelphia) Annual Meeting

Contributed Session
Overrunning in Clinical Trials: a Methodological Review

Session Details

Aenne Glass
2014 (Philadelphia) Annual Meeting

Contributed Session
PAIN MANAGEMENT AFTER CESAREAN – A RANDOMIZED CONTROLLED TRIAL OF OXYCODON VS. INTRAVENOUS PIRITRAMIDE

Session Details

Abigail Shoben
2014 (Philadelphia) Annual Meeting

Contributed Session
Particular challenges of sequential analysis in cluster randomized trials

Session Details

Thomas Dobbins
2014 (Philadelphia) Annual Meeting

Contributed Session
Partitioning the type II error probability of a group sequential test of efficacy and futility: a new approach to setting power and sample size

Session Details

Neil Wohlford
2014 (Philadelphia) Annual Meeting

Contributed Session
PATIENT PROFILE PLOTS IN DSMB REPORTS

Session Details

Erik Doffagne
2014 (Philadelphia) Annual Meeting

Contributed Session
PRACTICAL IMPLEMENTATION OF CENTRAL STATISTICAL MONITORING

Session Details

Deborah Sherratt
2014 (Philadelphia) Annual Meeting

Contributed Session
Practicalities of performing independent response assessment in the myeloma setting

Session Details

Isabelle Smith
2014 (Philadelphia) Annual Meeting

Contributed Session
Pressure RElieving Support SUrfaces: a Randomised Evaluation 2 (PRESSURE 2)

Session Details

iftekhar Khan
2014 (Philadelphia) Annual Meeting

Contributed Session
Probabilistic sensitivity Analyses for Clinical Trials of Cost-Effectiveness using the method of Copulas: A comparison of simulation methods

Session Details

David Lau
2014 (Philadelphia) Annual Meeting

Contributed Session
PROCEDURES AND CHALLENGES INVOLVED IN MIGRATING DATA FROM A PRIMARY STUDY TO A FOLLOW-UP STUDY

Session Details

Anne Davis-Karim
2014 (Philadelphia) Annual Meeting

Contributed Session
Quality verification after the fact: The value, reasoning and methodology behind a post-hoc assessment of quality by design in the manufacturing and packaging of drugs in a multi-center clinical trial

Session Details

Kath Starr
2014 (Philadelphia) Annual Meeting

Contributed Session
Quantifying non-response to questionnaires and strategies for improvement

Session Details

David Luckenbaugh
2014 (Philadelphia) Annual Meeting

Contributed Session
Rating Depression Over Brief Time Spans: The Value of Standard vs. Abbreviated Scales

Session Details

Karen Bracken
2014 (Philadelphia) Annual Meeting

Contributed Session
Recruiting to an Australian prevention study through mainstream media, social media and local promotion: lessons learned

Session Details

Amy Bartlett
2014 (Philadelphia) Annual Meeting

Contributed Session
Recruitment Methods Employed in the NeuroNEXT SMA Biomarker Study

Session Details

Sarah Gaussoin
2014 (Philadelphia) Annual Meeting

Contributed Session
RECRUITMENT OF PARTICIPANTS INTO A MAGNETIC RESONANCE IMAGING STUDY: RESULTS FROM THE SYSTOLIC BLOOD PRESSURE INTERVENTION TRIAL (SPRINT)

Session Details

Sonya Mergler
2014 (Philadelphia) Annual Meeting

Contributed Session
REGULATORY CONSIDERATIONS IN AN INTERNATIONAL MULTI-CENTRE ACADEMIC TRIAL OF A MEDICAL DEVICE

Session Details

Kathryn Cerullo
2014 (Philadelphia) Annual Meeting

Contributed Session
REIMBURSEMENT MODULE: A TOOL FOR TRACKING VISIT EXPENSES AND PARTNERSHIP REIMBURSEMENTS FOR THE NHLBI-FUNDED ASTHMA NETWORK (AsthmaNet)

Session Details

Kseniia Ratushna
2014 (Philadelphia) Annual Meeting

Contributed Session
RESEARCH AND ANALISYS OF THE RISK FACTORS IN CLINICAL DATA MANAGEMENT SYSTEM

Session Details

Kathleen Edson
2014 (Philadelphia) Annual Meeting

Contributed Session
ResearchMatch Increasing Patient Enrollment, Recruitment and Retention

Session Details

Liz Graham
2014 (Philadelphia) Annual Meeting

Contributed Session
Risk Management of Non-CTIMP Trials: focus on complex intervention trials

Session Details

SHIH-TING CHIU
2014 (Philadelphia) Annual Meeting

Contributed Session
Sample Size and Data Monitoring for Clinical Trials With Extremely Low Incidence Rates

Session Details

David Bristol
2014 (Philadelphia) Annual Meeting

Contributed Session
Sample Size Re-estimation Can Be Very Inefficient

Session Details

Lee McDaniel
2014 (Philadelphia) Annual Meeting

Contributed Session
Sample Size Under the Additive Hazards Model

Session Details

Borko Jovanovic
2014 (Philadelphia) Annual Meeting

Contributed Session
Sample Size, Components of Variance and Cost in Clinical Trials with Main Outcomes Based on Nested Lab Data

Session Details

Jordan Elm
2014 (Philadelphia) Annual Meeting

Contributed Session
Screen Failure Data in Clinical Trials: Are Screening Logs Worth It?

Session Details

Christina Yap
2014 (Philadelphia) Annual Meeting

Contributed Session
SCREENED SELECTION DESIGN FOR RANDOMISED PHASE II ONCOLOGY TRIALS: AN EXAMPLE IN CHRONIC LYMPHOCYTIC LEUKAEMIA

Session Details

Christopher Tait
2014 (Philadelphia) Annual Meeting

Contributed Session
Seamless Phase I/II Adaptive Design for Oncology Trials of Molecular Targeted Agents

Session Details

Xuezhou Mao
2014 (Philadelphia) Annual Meeting

Contributed Session
Sequential designs for individualized dosing in phase I cancer clinical trials

Session Details

Gerald Beck
2014 (Philadelphia) Annual Meeting

Contributed Session
SEQUENTIAL VERSUS CONCURRENT READINGS OF CARDIAC MRIs IN A CLINICAL TRIAL

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Reza Rostami
2014 (Philadelphia) Annual Meeting

Contributed Session
Sharing clinical research data

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Vadim Tantsyura
2014 (Philadelphia) Annual Meeting

Contributed Session
Simplified approach to risk-based source data verification

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Neil Baron
2014 (Philadelphia) Annual Meeting

Contributed Session
Simulation of Interim Safety Data

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Francesca Fiorentino
2014 (Philadelphia) Annual Meeting

Contributed Session
Simulation of the power of methods for analysing longitudinal biomarker data

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Elizabeth Zahn
2014 (Philadelphia) Annual Meeting

Contributed Session
Simulation Study to Assess an a Priori Decision Algorithm for a Randomized Three Armed Clinical Trial

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Ying Lu
2014 (Philadelphia) Annual Meeting

Contributed Session
Simultaneous Inference for Joint Overall and Subgroup Confirmatory Hypothesis Testing

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Gustav Vella
2014 (Philadelphia) Annual Meeting

Contributed Session
Site-Sponsor-Interfaces for Managing Common Organizational Data – Harmonizing Approaches in the United Kingdom and Germany

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Jeffrey Rohay
2014 (Philadelphia) Annual Meeting

Contributed Session
STATISTICAL ASSESSMENT OF MEDICATION ADHERENCE DATA: A TECHNIQUE TO ANALYZE THE J-SHAPED CURVE

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Ellen Asam
2014 (Philadelphia) Annual Meeting

Contributed Session
Statistical Programming Compliance – Why Do We Continue to Struggle?

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Marion Campbell
2014 (Philadelphia) Annual Meeting

Contributed Session
STEPPED WEDGE DESIGNS – THREAT OR PROMISE?

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Megan Ryan
2014 (Philadelphia) Annual Meeting

Contributed Session
Strategies for Conducting Multi-site Clinical Trials for Alcohol Dependence

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Adriana Rodriguez
2014 (Philadelphia) Annual Meeting

Contributed Session
Strategies Implemented to Facilitate Cooperation between Primary Study Sites and Follow-up Study Sites with Different Study Populations

Session Details

Salwa Hasan
2014 (Philadelphia) Annual Meeting

Contributed Session
Strategies implemented to optimize recruitment in a drug trial for mothers of high-risk infants

Session Details

Asma Qureshi
2014 (Philadelphia) Annual Meeting

Contributed Session
Strategies to Ensure Compliance for a Multi-Centre Academic Regulated Clinical Trial

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Angela Knox
2014 (Philadelphia) Annual Meeting

Contributed Session
STRATEGIES TO REDUCE THE STUDY START-UP TIMELINE: A COORDINATION CENTER PERSPECTIVE

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Yoko Kai
2014 (Philadelphia) Annual Meeting

Contributed Session
Streamlining of the data manager workflow with software package for project management.

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Byoung-Kab Kang
2014 (Philadelphia) Annual Meeting

Contributed Session
Study II of Diagnosis Criteria for Qi deficiency in Stroke

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Julie Croft
2014 (Philadelphia) Annual Meeting

Contributed Session
SUCCESSFUL NAVIGATION THROUGH THE CHALLENGES OF INTERNATIONAL TRIAL SET UP

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Cal Collins
2014 (Philadelphia) Annual Meeting

Contributed Session
Successful Patient Engagement Using Web and Mobile Technology

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Andrew Cook
2014 (Philadelphia) Annual Meeting

Contributed Session
SURGICAL MANAGEMENT OF DEVELOPMENTAL DYSPLASIA OF THE HIP - A TALE OF TWO HATS

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Tao Wang
2014 (Philadelphia) Annual Meeting

Contributed Session
System Driven DICOM Imaging QC – Automatic Protocol Compliance Check on DICOM Images at the Submission Point

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Deborah Felton
2014 (Philadelphia) Annual Meeting

Contributed Session
Systolic Blood Pressure Intervention Trial Web-Based Adverse Event Tracking: A Tool for Reporting and Managing Participant Safety Events in a Large Clinical Trial

Session Details

Neal Oden
2014 (Philadelphia) Annual Meeting

Contributed Session
Tangency Outcomes for Clinical Trials

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Jennifer Gassman
2014 (Philadelphia) Annual Meeting

Contributed Session
The challenge of collecting of ABPM and Home BP data in a clinical trial of hemodialysis patients – a report from the Blood Pressure in Hemodialysis (BID) Pilot Study

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Pollyanna Hardy
2014 (Philadelphia) Annual Meeting

Contributed Session
The CORONIS Trial: a non-regular fractional factorial design. Why and how?

Session Details

Evan Hempel
2014 (Philadelphia) Annual Meeting

Contributed Session
THE DOWNFALL OF THE DCF: TRANSITIONING TO THE AGE OF ENTIRELY ELECTRONIC DATA MANAGEMENT

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Sean Strong
2014 (Philadelphia) Annual Meeting

Contributed Session
The feasibility of a randomised controlled trial of definitive chemoradiotherapy or chemotherapy and surgery for localised oesophageal squamous cell cancer

Session Details

Wenle Zhao
2014 (Philadelphia) Annual Meeting

Contributed Session
The impact of response adaptive randomization and time trends on the type I error in clinical trials

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Zhiying You
2014 (Philadelphia) Annual Meeting

Contributed Session
The minimum required number of clusters in cluster randomized trials

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Matthew Sydes
2014 (Philadelphia) Annual Meeting

Contributed Session
THE NEED FOR A CULTURAL SHIFT FROM TWO-ARM TO MULTI-ARM RANDOMISED CONTROLLED TRIALS

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Marianne Kearney
2014 (Philadelphia) Annual Meeting

Contributed Session
The NeuroNEXT Experience of Patient Engagement in Protocol Development

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Raye Litten
2014 (Philadelphia) Annual Meeting

Contributed Session
THE PLACEBO EFFECT IN CLINICAL TRIALS FOR ALCOHOL DEPENDENCE

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Steven Julious
2014 (Philadelphia) Annual Meeting

Contributed Session
The PLEASANT Trial: A Personal Perspective of a Statistician being a Chief Investigator

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Mohamed Mubasher
2014 (Philadelphia) Annual Meeting

Contributed Session
The Power and Robustness of Generalized Linear Mixed Modeling (GLMM) in the Presence of Missing Data to Accurately Predict Optimal Calcium and Vitamin D Doses among Post Thyroidectomy Patients

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Marisa De Rosa
2014 (Philadelphia) Annual Meeting

Contributed Session
The Survivorship passport: an innovative solution for long-term follow-up in childhood cancer

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Natalie Blencowe
2014 (Philadelphia) Annual Meeting

Contributed Session
The use of social media to recruit to multicentre studies: a multi-faceted approach

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Laura Keita
2014 (Philadelphia) Annual Meeting

Contributed Session
The vital (often disregarded) aspect of training in the clinical system validation process.

Session Details

Jane Blazeby
2014 (Philadelphia) Annual Meeting

Contributed Session
This resulted in most strategies being implemented and recruitment rates increased from <10% (2/22) in the first two months before feedback to 37% (36/98) in the five months following feedback. Current randomisation rate is 35% (74/209) and this is steadily increasing.This resulted in most strategies being implemented and recruitment rates increased from <10% (2/22) in the first two months before feedback to 37% (36/98) in the five months following feedback. Current randomisation rate is 35% (74/209) and this is steadily increasing.Key strategies used to optimise recruitment in the By-Band trial: findings from qualitative research

Session Details

Donna Levy
2014 (Philadelphia) Annual Meeting

Contributed Session
TITLE: TIME TO EVENT ANALYSES – FEAR NOT: WHAT EVERY PROGRAMMER AND STATISTICIAN WANTS & SHOULD KNOW

Session Details

Siobhan Tobin
2014 (Philadelphia) Annual Meeting

Contributed Session
TOOLS FOR ENSURING SITE COMPLIANCE TO GOOD CLINICAL PRACTICE STANDARDS IN A MULTI-CENTRE, REGULATED, ACADEMIC CLINICAL TRIAL

Session Details

Jason Tay
2014 (Philadelphia) Annual Meeting

Contributed Session
TRANSFUSION OF RED CELLS IN HEMATOPOIETIC STEM CELL TRANSPLANTATION (TRIST STUDY) - ADHERENCE TO RED BLOOD CELL TRANSFUSION THRESHOLD IN A RANDOMIZED CLINICAL TRIAL

Session Details

Jesper Grarup
2014 (Philadelphia) Annual Meeting

Contributed Session
Translating study documents – time, cost, and potential for streamlining in a large academic multinational trial

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Joshua Killion
2014 (Philadelphia) Annual Meeting

Contributed Session
Translational Research Specimen Tracking System

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Benjamin Carlisle
2014 (Philadelphia) Annual Meeting

Contributed Session
Trial Accrual and Ethics: An Empirical Analysis

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Casey Brescia
2014 (Philadelphia) Annual Meeting

Contributed Session
TRIAL AND ERROR: DELEGATION LOGS

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Joerg Hasford
2014 (Philadelphia) Annual Meeting

Contributed Session
Trials on Drugs and on Nutritional Interventions: what is different ?

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Susanne May
2014 (Philadelphia) Annual Meeting

Contributed Session
Type I error control in factorial non-inferiority trials

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Sean Strong
2014 (Philadelphia) Annual Meeting

Contributed Session
Understanding the role of teamwork in recruitment to randomised controlled trials in surgical oncology- results from an exploratory study

Session Details

Emily Wilson
2014 (Philadelphia) Annual Meeting

Contributed Session
Use of an Interactive Data Dashboard to Monitor Studies for Large Multi-Center Trials

Session Details

Nathan Bryant
2014 (Philadelphia) Annual Meeting

Contributed Session
Use of an interactive web-based heat map calendar to monitor study event data

Session Details

Qing Li
2014 (Philadelphia) Annual Meeting

Contributed Session
Use of cervical pessaries to prevent preterm delivery among twin gestations: Need for a priori sub-group analyses targeting PreCocious Cervical Ripening

Session Details

Nicole Puccinelli-Ortega
2014 (Philadelphia) Annual Meeting

Contributed Session
Use of instructional videos for clinical site staff training in the multi-center clinical trial The Systolic Blood Pressure Intervention Trial (SPRINT)

Session Details

Rachel Berry
2014 (Philadelphia) Annual Meeting

Contributed Session
Using a Variety of Instructional Methodologies in Conducting Clinical Site Training

Session Details

Jennifer Talton
2014 (Philadelphia) Annual Meeting

Contributed Session
USING AN AUTOMATED APPROACH FOR DISSEMINATING PARTICIPANT RESULTS IN GRAPHIC FORM

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Amita Mirani
2014 (Philadelphia) Annual Meeting

Contributed Session
Value-Based Data Management: An Economic and Quality-Focused Approach

Session Details

Stuart Nicholls
2014 (Philadelphia) Annual Meeting

Contributed Session
Watching the watchmen: A scoping review of empirical studies evaluating research ethics review

Session Details

Eric Tustison
2014 (Philadelphia) Annual Meeting

Contributed Session
Web-Based EDC Training with Content Classification for Greater Efficiency and Consistency

Session Details

Spencer Hey
2014 (Philadelphia) Annual Meeting

Contributed Session
What Do Researcher Believe About Risks in Trials? Results of a Pilot Study

Session Details

Jamie Oughton
2014 (Philadelphia) Annual Meeting

Contributed Session
When the LANTERN goes out: feasibility studies in a changing clinical environment.

Session Details

Silbergleit et al
2013 (Boston) Annual Meeting

Trial of the Year Award
Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART)

Richard Saitz
2013 (Boston) Annual Meeting

Founders Lecture
Challenges for Health Behavior Trials from Design to Practice: The Example of Unhealthy Alcohol Use

Paul Wakim
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Practical Statistical Reasoning in Clinical Trials for Non-Statsticians (3) Trial Monitoring (Interim analyses & sample-size recalculation)

Paul Wakim
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Practical Statistical Reasoning in Clinical Trials for Non-Statsticians (5) Publication of Results

Michele Melia
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Practical Statistical Reasoning in Clinical Trials for Non-Statsticians (4) Final Analysis & Subgroup Analysis (reject H0, p-value, correct, site-by-treatment interaction)

Paul Wakim
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Practical Statistical Reasoning in Clinical Trials for Non-Statsticians (2) Analysis Plan (simple vs. complex, use of covariates, longitudinal models, handling missing data)

Michele Melia
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Practical Statistical Reasoning in Clinical Trials for Non-Statsticians (1) Overview of Trial Design (hypothesis testing, sample size, power)

Karthik Venkatakrishnan
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Clinical Pharmacology and Pharmacometrics for Statisticians and Clinical Trialists (3) Drug-Drug Interactions and Pharmacogenomic Variation (Part 2 - Application in Therapuetics and Drug Development)

Karthik Venkatakrishnan
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Clinical Pharmacology and Pharmacometrics for Statisticians and Clinical Trialists (2) Drug-Drug Interactions and Pharmacogenomic Variation (Part 1 - Illustrated Examples of Principles)

Kevin Sweeney
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Clinical Pharmacology and Pharmacometrics for Statisticians and Clinical Trialists (4) Principles of Pharmacometrics

David Greenblatt
2013 (Boston) Annual Meeting

Special Presentation
Workshop - Clinical Pharmacology and Pharmacometrics for Statisticians and Clinical Trialists (1) Pharmacokenetics

Peter Peduzzi
2013 (Boston) Annual Meeting

Fellows Presentation
Presentation of the Class of 2013 Fellows

Atul Butte
2013 (Boston) Annual Meeting

Curtis Meinert Lecture
Transforming a Trillion Points of Data into Diagnostics, Therapeutics, and New Insights into Disease

Dale Williams
2013 (Boston) Annual Meeting

Special Presentation
35 Years of SCT

Anne Lindblad
2013 (Boston) Annual Meeting

Presidential Welcome

Natalie Nardone
2013 (Boston) Annual Meeting

Contributed Session
A Bayesian Analysis of a Clinical Trial for Treatment of Uveitis

Session Details

Marie-Karelle RIVIERE
2013 (Boston) Annual Meeting

Contributed Session
A Bayesian Dose-finding Design for Clinical Trials Combining a Cytotoxic Agent with a Biological Agent

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Donald Chi
2013 (Boston) Annual Meeting

Contributed Session
A community-based clinical trial to improve the oral health-related knowledge and self-efficacy of Korean-American caregivers of young children

Session Details

TAO WANG
2013 (Boston) Annual Meeting

Contributed Session
A COMPARISON OF THE 3+3 DESIGN, THE ROLLING SIX DESIGN, THE CRM, AND THE MODIFIED CRM IN PHASE I CLINICAL TRIALS USING DISCRETE EVENT SIMULATION

Session Details

Cody Chiuzan
2013 (Boston) Annual Meeting

Contributed Session
A likelihood-based approach to selecting doses with acceptable toxicity in a standard algorithm-based phase I cancer trial

Session Details

cathy yang
2013 (Boston) Annual Meeting

Contributed Session
A Multi-system Setup for Developing Electronic Case Report Forms (e-CRFs)

Session Details

KyungMann Kim
2013 (Boston) Annual Meeting

Contributed Session
A New Paradigm for Large, Simple Trials Based on Electronic Health Records

Session Details

Richard Emsley
2013 (Boston) Annual Meeting

Contributed Session
A NEW TRIAL DESIGN FULLY INTEGRATING BIOMARKER INFORMATION FOR THE EVALUATION OF TREATMENT-EFFECT MECHANISMS IN PERSONALISED MEDICINE

Session Details

Jin Zhang
2013 (Boston) Annual Meeting

Contributed Session
A Phase I Bayesian Adaptive Design to Simultaneously Optimize Dose and Schedule Assignments Both Among and Within Patients

Session Details

Karisse Torres
2013 (Boston) Annual Meeting

Contributed Session
A Practical Approach to Estimating Effect of Change in Recruitment Duration, Cluster Size, and Number of Cluster Units on Statistical Power of a Cluster Randomized Trial

Session Details

Jonathan Wright
2013 (Boston) Annual Meeting

Contributed Session
A PRACTICAL EXAMPLE OF APPROACHES TAKEN TO HANDLE COMPLEXITIES IN MULTIPLE EVENTS ANALYSIS

Session Details

Tracy Bergemann
2013 (Boston) Annual Meeting

Contributed Session
A smooth estimate of the hazard ratio over a continuous covariate

Session Details

MI MI KO
2013 (Boston) Annual Meeting

Contributed Session
A Study of Tongue and Pulse Diagnosis in Traditional Korean Medicine for the Stroke Patients Based on Quantification Theory Type II

Session Details

Jonathan Cook
2013 (Boston) Annual Meeting

Contributed Session
A systematic review of methods for specifying the target difference in randomised controlled trials (DELTA review)

Session Details

Theodore Karrison
2013 (Boston) Annual Meeting

Contributed Session
A VERSATILE TEST FOR COMPARING SURVIVAL CURVES BASED ON WEIGHTED LOG-RANK STATISTICS

Session Details

Qiang Zhang
2013 (Boston) Annual Meeting

Contributed Session
A Weibull model for the correlation between progression-free survival and overall survival

Session Details

Spencer Hey
2013 (Boston) Annual Meeting

Contributed Session
Accumulating Evidence and Research Organization (AERO) Model: A New Tool for Representing, Analyzing, and Planning A Translational Research Program

Session Details

Brian Hobbs
2013 (Boston) Annual Meeting

Contributed Session
Adaptive adjustment of the randomization ratio using historical control data

Session Details

Neal Oden
2013 (Boston) Annual Meeting

Contributed Session
Algorithms for inference following Bernoulli random walks with desirable absorbing boundaries

Session Details

Cassidy Conner
2013 (Boston) Annual Meeting

Contributed Session
An analysis of data changes in response to real-time protocol violation (PV) alerts in an Electronic Data Capture (EDC) system

Session Details

Kellee Miller
2013 (Boston) Annual Meeting

Contributed Session
An Assessment of Agreement between Self-reported and Clinic-reported Data Collection in a Type 1 Diabetes Clinic Registry

Session Details

Gregory Levin
2013 (Boston) Annual Meeting

Contributed Session
An Evaluation of Inferential Procedures for Adaptive Clinical Trial Designs with Pre-specified Rules for Modifying the Sample Size

Session Details

Jonathan Hartzel
2013 (Boston) Annual Meeting

Contributed Session
Application of a Seamless Phase II/III, Group-Sequential Design in the Development of a S. aureus Vaccine

Session Details

Valerie Durkalski
2013 (Boston) Annual Meeting

Contributed Session
ASSESSING THE ‘SUCCESS’ OF THE BLIND IN SHAM-CONTROLLED RANDOMIZED CLINICAL TRIALS AND THE IMPACT ON TREATMENT EFFECT

Session Details

Yumi Kubo
2013 (Boston) Annual Meeting

Contributed Session
Assessing the actual treatment benefit with non-adherence to study drug in a large randomized trial

Session Details

JIAJING XU
2013 (Boston) Annual Meeting

Contributed Session
Bayesian Model Selection Approach to Dose Finding in Two-stage Clinical Trials for Cytostatic Agents.

Session Details

Sheng Luo
2013 (Boston) Annual Meeting

Contributed Session
Bayesian Multiple Imputation for Missing Multivariate Longitudinal Data from a Parkinson's Disease Clinical Trial

Session Details

Christina Tittsworth
2013 (Boston) Annual Meeting

Contributed Session
Beware of Too Many Cooks in the Kitchen: Concocting the Perfect Query Recipe

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Adrielle Houweling
2013 (Boston) Annual Meeting

Contributed Session
BLINDING STRATEGIES AND THEIR EFFECT IN A RANDOMIZED PLACEBO-CONTROLLED TRIAL (RCT) OF ELASTIC COMPRESSION STOCKINGS (ECS) FOR PREVENTION OF POST-THROMBOTIC SYNDROME (PTS)

Session Details

Robert Parker
2013 (Boston) Annual Meeting

Contributed Session
Can We Explain the Drop in Efficacy in as Drugs Progress to Later Stage Clinical Trials?

Session Details

Adrian Gheorghe
2013 (Boston) Annual Meeting

Contributed Session
Center selection in clinical trials and the generalizability of results: a mixed methods study

Session Details

Joerg Hasford
2013 (Boston) Annual Meeting

Contributed Session
CHALLENGES OF COMPOSITE ENDPOINTS FOR TRIAL EXECUTION, STATISTICAL ANALYSIS AND INTERPRETATION

Session Details

Jenny Tseng
2013 (Boston) Annual Meeting

Contributed Session
Challenges in Analyzing Safety Data in a Phase III Trial to Evaluate the Safety of Extended Regimen of Nevirapine (NVP) in Infants Born to HIV-infected Mothers to Prevent Vertical HIV Transmission during Breastfeeding (HPTN 046)

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Shelly Lensing
2013 (Boston) Annual Meeting

Contributed Session
Challenges in Quantifying Physical Activity with Tri-Axial Accelerometers in a Randomized Controlled Clinical Trial of a Lifestyle Intervention in Sedentary Older Women

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Jessica Stucker
2013 (Boston) Annual Meeting

Contributed Session
Challenges of Providing Medical Results to Participants in Field-Based Studies: Experiences in the Gulf Long-Term Follow-Up Study (GuLF STUDY)

Session Details

Alice Sheffet
2013 (Boston) Annual Meeting

Contributed Session
CHARACTERISTICS OF PARTICIPANTS AGREEING TO LONG-TERM (UP TO TEN YEARS) FOLLOW-UP IN A LARGE RANDOMIZED CLINICAL TRIAL

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uma kher
2013 (Boston) Annual Meeting

Contributed Session
Characterization of bias between validated assays using regression methods

Session Details

Xiaoyu Jia
2013 (Boston) Annual Meeting

Contributed Session
Characterization of two-stage likelihood continual reassessment method

Session Details

Anne Zielinski
2013 (Boston) Annual Meeting

Contributed Session
Clinical Data from Everyone

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Dawn Hunt
2013 (Boston) Annual Meeting

Contributed Session
Clinical Monitoring: A Collaborative Approach. Process and Outcomes of Implementing a Clinical Monitoring Program in the National Institute of Environmental Health Sciences Clinical Research Unit

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Henian Chen
2013 (Boston) Annual Meeting

Contributed Session
Collecting Data from Nonrespondents in Quality of Life: Benefits and Implications

Session Details

Karen Briggs
2013 (Boston) Annual Meeting

Contributed Session
Common Mistakes to Avoid in Clinical Trial Case Report Form Design

Session Details

Ashley Pinckney
2013 (Boston) Annual Meeting

Contributed Session
Comparability of CTCAE grading and clinical significance in abnormal clinical laboratory results

Session Details

Christina Yap
2013 (Boston) Annual Meeting

Contributed Session
Comparing the implementation of a Modified Continual Reassessment Method to a Traditional 3+3 Design in a Phase I Acute Myeloid Leukaemia Trial

Session Details

Amit Chowdhry
2013 (Boston) Annual Meeting

Contributed Session
Comparison of a Linear Mixed Effects Model and Mixed Model Repeated Measures for Analyzing Incomplete Longitudinal Data in Clinical Trials

Session Details

Tsung Yu
2013 (Boston) Annual Meeting

Contributed Session
Comparison of benefits and harms of roflumilast in patients with moderate to severe chronic obstructive pulmonary disease and a history of exacerbations

Session Details

Greg Ball
2013 (Boston) Annual Meeting

Contributed Session
CONTINUOUS SAFETY MONITORING FOR RANDOMIZED CONTROLLED CLINICAL TRIALS WITH BLINDED TREATMENT INFORMATION

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zhengjia Chen
2013 (Boston) Annual Meeting

Contributed Session
Continuous Tumor Size Change Percentage and Progression Free Survival as Endpoint of the First and Second Stage Respectively in a Novel Double Screening Phase II Design

Session Details

Valerie Stevenson
2013 (Boston) Annual Meeting

Contributed Session
Correlation of a Form-based Versus Item-based Metric of Data Accuracy In Case Report Form Completion in a Clinical Trial Network

Session Details

Siyan Xu
2013 (Boston) Annual Meeting

Contributed Session
Covariate effect on constancy assumption in active controlled clinical trials

Session Details

akiko kada
2013 (Boston) Annual Meeting

Contributed Session
Creating a new Scoring Endpoint of Cardiac Events and Questionnaire-based Heart Failure Symptom

Session Details

Ying Lu
2013 (Boston) Annual Meeting

Contributed Session
Cross-sectional and short-term follow-up design to retrospectively estimate odds ratios

Session Details

Ellen Peskin
2013 (Boston) Annual Meeting

Contributed Session
CURRENT PRACTICES IN REMOTE MONITORING VISITS

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Tingting Li
2013 (Boston) Annual Meeting

Contributed Session
DATA MONITORING COMMITTEES IN CHINA

Session Details

Jessica Stortz
2013 (Boston) Annual Meeting

Contributed Session
DELEGATION LOGS IN A REGULATED CLINICAL TRIAL INVOLVING MULTIDISCIPLINARY TEAMS

Session Details

Cécile Chauvel
2013 (Boston) Annual Meeting

Contributed Session
Design and analysis of a clinical trial in which mild to moderate non-proportional hazards is a possibility

Session Details

Andrew Forbes
2013 (Boston) Annual Meeting

Contributed Session
Design and analysis of cluster randomized crossover trials with binary outcomes with application to intensive care research

Session Details

Katherine Huppler Hullsiek
2013 (Boston) Annual Meeting

Contributed Session
DESIGN OF AN INTERNATIONAL CLUSTER-RANDOMIZED TRIAL COMPARING TWO DATA MONITORING PRACTICES

Session Details

Semhar Ogbagaber
2013 (Boston) Annual Meeting

Contributed Session
Design of Sequentially Randomized Trials for Testing Adaptive Treatment Strategies

Session Details

Siew Wan Hee
2013 (Boston) Annual Meeting

Contributed Session
DESIGNING A SERIES OF HYBRID TRIALS WITH CONTINUOUS OUTCOMES

Session Details

Johanna Sanchez
2013 (Boston) Annual Meeting

Contributed Session
DEVELOPING AN ONLINE TRAINING MODULE FOR MULTICENTRE TRIALS

Session Details

Roberta Constantine
2013 (Boston) Annual Meeting

Contributed Session
Developing Approaches for Randomization within the Mini-Sentinel Distributed Database

Session Details

Danielle Chandler
2013 (Boston) Annual Meeting

Contributed Session
DEVELOPMENT OF A PARENT INFORMATIONAL VIDEO TO AID RECRUITMENT IN A PEDIATRIC SURGICAL RANDOMIZED TRIAL

Session Details

John Podoba
2013 (Boston) Annual Meeting

Contributed Session
DEVELOPMENT OF AN ALGORITHM AND A WEB-BASED SOFTWARE MODULE FOR SINGLE AND MULTI-STAGE PATIENT ENROLLMENT PROCESSES FOR WEB RANDOMIZATION

Session Details

Sherrie Whisler
2013 (Boston) Annual Meeting

Contributed Session
Development of Data Diamond Reporting System

Session Details

Peter Merrill
2013 (Boston) Annual Meeting

Contributed Session
Dichotomizing Partial Compliance and Increased Participant Burden in Factorial Designs: The Performance of Four Non-Compliance Methods

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Scott Rushing
2013 (Boston) Annual Meeting

Contributed Session
Digital Data Collection – The LIFE Experience

Session Details

Graeme MacLennan
2013 (Boston) Annual Meeting

Contributed Session
Do advance telephone calls ahead of reminder questionnaires increase response rate in non-responders compared to questionnaire reminders only: The RECORD Phone Trial.

Session Details

Leah Griffin
2013 (Boston) Annual Meeting

Contributed Session
Dynamic Web-Based Management of a Lifestyle Intervention: The Study of Novel Approaches to Prevention Clinical Trial

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Peter Thall
2013 (Boston) Annual Meeting

Contributed Session
Dysfunctional Conventions in Clinical Trials: Some Bayesian Alternatives

Session Details

Sarah Gaussoin
2013 (Boston) Annual Meeting

Contributed Session
EFFECTIVENESS OF A MID-TRIAL TRAINING SESSION FOR MONITORING SERIOUS ADVERSE EVENTS: EXPERIENCE IN ACTION FOR HEALTH IN DIABETES (LOOK AHEAD) STUDY

Session Details

DONG VO
2013 (Boston) Annual Meeting

Contributed Session
Electronic Conversion and Archiving of clinical trial paper records

Session Details

Martina Mueller
2013 (Boston) Annual Meeting

Contributed Session
Enhanced protocol compliance in a complex clinical trial using web-based response adaptive treatment instructions

Session Details

Ainy Zahid
2013 (Boston) Annual Meeting

Contributed Session
ENSURING ACCURATE OUTCOMES REVIEW FOR DATA ANALYSIS

Session Details

Asma Qureshi
2013 (Boston) Annual Meeting

Contributed Session
ENSURING COMPLIANCE TO GOOD CLINICAL PRACTICE REQUIREMENTS IN MULTI-CENTRE STUDIES

Session Details

Ye Cui
2013 (Boston) Annual Meeting

Contributed Session
Escalation with Overdose Control using All Toxicities and Time to Toxicity Data for Cancer Phase I Clinical Trials

Session Details

Ruediger Laubender
2013 (Boston) Annual Meeting

Contributed Session
Estimating heterogeneous treatment effects from data generated in randomized controlled trials based on the parallel group design using predictive baseline covariates.

Session Details

Dorothee Arenz
2013 (Boston) Annual Meeting

Contributed Session
Estimating Site Costs Prior to Conducting Clinical Trials – A Study Site Budgeting Tool

Session Details

Jae Eun Lee
2013 (Boston) Annual Meeting

Contributed Session
Evaluating Potential Impact of Modified Eligibility Criteria on Enrollment and Study Results in Cardiovascular Clinical Trials

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Leslie McClure
2013 (Boston) Annual Meeting

Contributed Session
Evaluating the Impact of Increasing the Sample Size in the Secondary Prevention of Small Subcortical Strokes (SPS3) Trial: Hindsight is 20/20

Session Details

Rebecca Elmore
2013 (Boston) Annual Meeting

Contributed Session
EVALUATION OF RETENTION RATES BY DEMOGRAPHIC CHARACTERISTICS IN THE ENVIRONMENTAL POLYMORPHISM REGISTRY (EPR)

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Janice Pogue
2013 (Boston) Annual Meeting

Contributed Session
Evidence Informed Missing Data Imputation for Cognitive Function Tests within RCTs

Session Details

L. Suzanne Firrell
2013 (Boston) Annual Meeting

Contributed Session
Evolving Best Practices to Meet the Demands of Revolutionizing Research at Coordinating Centers

Session Details

John Hermos
2013 (Boston) Annual Meeting

Contributed Session
FACTORS ASSOCIATED WITH RETENTION OF AFRICAN-AMERICAN AND WHITE PARTICIPANTS IN A PROSTATE CANCER PREVENTION TRIAL

Session Details

Charles Heisey
2013 (Boston) Annual Meeting

Contributed Session
FAMILY FORUMS: A MODEL FOR PARTICIPANT EDUCATION AND ENGAGEMENT

Session Details

Louise Flanagan
2013 (Boston) Annual Meeting

Contributed Session
From late phase to early phase: experiences of establishing a disease-specific early phase trials unit

Session Details

Elizabeth Nelson
2013 (Boston) Annual Meeting

Contributed Session
FROM THE LAB TO THE NETWORK: MANAGEMENT OF EXPERIMENTAL, CLINICAL AND SPECIMEN DATA USING THE OPEN SOURCE LABKEY SERVER SYSTEM

Session Details

Sharon Yeatts
2013 (Boston) Annual Meeting

Contributed Session
Futility Design Incorporating Concurrent Controls: A Variation on the Phase II Trial Design

Session Details

Elizabeth Sugar
2013 (Boston) Annual Meeting

Contributed Session
Graphical Methods for Monitoring Clinical Trial Data

Session Details

David Smith
2013 (Boston) Annual Meeting

Contributed Session
Has the Voluntary Harmonisation Procedure been a successful attempt to streamline the approval process for multinational clinical trials in the EU? Examining applicants’ experience to date with the GTFG’s initiative.

Session Details

Yannan Jiang
2013 (Boston) Annual Meeting

Contributed Session
Heart Exercise and Remote Technologies (HEART): A Randomized Controlled Trial

Session Details

J Athene Lane
2013 (Boston) Annual Meeting

Contributed Session
HOW DO TRIAL STEERING COMMITTEES AND MANAGEMENT GROUPS CONTRIBUTE TO TRIAL CONDUCT?

Session Details

Deborah Toyota
2013 (Boston) Annual Meeting

Contributed Session
How Much is Enough: A Risk Based Approach to Analysis Verification

Session Details

Phyllis Silverman
2013 (Boston) Annual Meeting

Contributed Session
How to Get the Most Out of Your Courtship with FDA - An FDA Medical Device Reviewer's Perspective

Session Details

Erik Doffagne
2013 (Boston) Annual Meeting

Contributed Session
IDENTIFYING ATYPICAL SITES WITH CENTRAL STATISTICAL MONITORING

Session Details

Ming-Wen An
2013 (Boston) Annual Meeting

Contributed Session
Identifying continuous Phase II endpoints using RECIST 1.1 data warehouse measurements

Session Details

Rajnish Mago
2013 (Boston) Annual Meeting

Contributed Session
Identifying Potential Adverse Effects by Patients’ Ratings: A Proof-of-Concept Study of a Novel Approach

Session Details

Moonseong Heo
2013 (Boston) Annual Meeting

Contributed Session
Impact of subject attrition on sample size determinations for longitudinal cluster randomized clinical trials

Session Details

Gary Gensler
2013 (Boston) Annual Meeting

Contributed Session
IMPLEMENTING A CENTRAL MONITORING PROCESS

Session Details

Chad Shenk
2013 (Boston) Annual Meeting

Contributed Session
Implementing Clinical Trials Methodology into the Everyday Care of Abused Children

Session Details

Colin Everett
2013 (Boston) Annual Meeting

Contributed Session
Implementing unbalanced assignment by minimisation

Session Details

Brandi Meeks
2013 (Boston) Annual Meeting

Contributed Session
Improved Recruitment Rates in a Randomized Controlled Trial of Acute Myocardial Infarction through use of a Web-based Interface for Central Randomization

Session Details

Dena Cohen
2013 (Boston) Annual Meeting

Contributed Session
INCORPORATING EMERGING THERAPIES INTO ONGOING RANDOMISED CLINICAL TRIALS

Session Details

Jing Zhou
2013 (Boston) Annual Meeting

Contributed Session
Information-Based Sample Size Re-estimation in Group Sequential Design for Longitudinal Trials

Session Details

Jason Griffin
2013 (Boston) Annual Meeting

Contributed Session
INTEGRATING STUDY DATA FROM MULTIPLE SOURCES USING SQL SERVER - THE ACCORDION STUDY

Session Details

Zhibo Wang
2013 (Boston) Annual Meeting

Contributed Session
Interactive Statistical Software for Estimating the Operating Characteristics of Cancer Phase I Clinical Trial Designed with Standard 3+3 Algorithm

Session Details

Ashutosh Ranjan
2013 (Boston) Annual Meeting

Contributed Session
INTERNAL PILOT DESIGN FOR CLUSTER RANDOMIZED TRIALS WITH UNEQUAL CLUSTER SIZES

Session Details

Joseph Rausch
2013 (Boston) Annual Meeting

Contributed Session
Investigating Treatment Effect Variability in Randomized Longitudinal Clinical Trials

Session Details

Bergman Sam
2013 (Boston) Annual Meeting

Contributed Session
KEY DATA EDITING FEATURES OF THE BSC DATA MANAGEMENT SYSTEM FOR COORDINATING CENTERS IN MULTI-CENTER CLINICAL TRIALS

Session Details

Patrick Chassaigne
2013 (Boston) Annual Meeting

Contributed Session
Leveraging IT tools for Comparative Effectiveness Research

Session Details

Megan Smith
2013 (Boston) Annual Meeting

Contributed Session
Likelihood-based methods for the prediction of endpoint occurrences in clinical trials

Session Details

NICHOLAS COUNSELL
2013 (Boston) Annual Meeting

Contributed Session
LITERATURE REVIEW TO COMPARE INTERIM AND FINAL RESULTS OF PUBLISHED CLINICAL TRIALS

Session Details

Mae Gordon
2013 (Boston) Annual Meeting

Contributed Session
Locating Study Participants 5 years After Closeout

Session Details

Catherine Lowe
2013 (Boston) Annual Meeting

Contributed Session
Logistical considerations for independent review of patient imaging for quality assurance or real time reporting in oncology clinical trials

Session Details

Zhibao Mi
2013 (Boston) Annual Meeting

Contributed Session
Lumping and Splitting Approach to Analyzing High Dimensional Sparse Counts Data

Session Details

Steven Ramsey
2013 (Boston) Annual Meeting

Contributed Session
Managing Performance of Field Staff in the Gulf Long-Term Follow-up Study (GuLF STUDY)

Session Details

Maiken Pontoppidan
2013 (Boston) Annual Meeting

Contributed Session
Measuring mental health, attachment, and behavioural development in 0-1 year old infants and their parents

Session Details

Valerie Brueton
2013 (Boston) Annual Meeting

Contributed Session
Measuring the impact of methodological research at the UK Medical Research Council Clinical Trials Unit

Session Details

Abigail Shoben
2013 (Boston) Annual Meeting

Contributed Session
Meta-analysis of one outcome from group sequential trials with composite outcomes: Are standard methods appropriate?

Session Details

Sean Neal
2013 (Boston) Annual Meeting

Contributed Session
Minimizing Reconciliation between Safety and Clinical Databases

Session Details

Vicki Lu
2013 (Boston) Annual Meeting

Contributed Session
Missing Data in Clinical Trials

Session Details

Erica Love
2013 (Boston) Annual Meeting

Contributed Session
MONITORING COMPLIANCE ON CANCER CLINICAL TRIALS: A PEER REVIEW MECHANISM FOR CONTINUOUS QUALITY IMPROVEMENT

Session Details

Jye-Yu Backlund
2013 (Boston) Annual Meeting

Contributed Session
Morbidity Adjudication and Tracking during DCCT/EDIC

Session Details

Elena Biffi
2013 (Boston) Annual Meeting

Contributed Session
Morphologic characteristics of different types of drusen as revealed by SD-OCT

Session Details

Christopher Crean
2013 (Boston) Annual Meeting

Contributed Session
MULTIPLE PHARMACOKINETIC ASSESSMENTS OF FIVE UNIQUE FORMULATIONS OF EZOGABINE/RETIGABINE COMPARED WITH THE IMMEDIATE RELEASE FORMULATION

Session Details

Yunzhi Lin
2013 (Boston) Annual Meeting

Contributed Session
Multiple Testing in Clinical Trials: Some New Applications

Session Details

Kenneth Clark
2013 (Boston) Annual Meeting

Contributed Session
National Lung Screening Trial (NLST): Post-Trial Data and Image Exploration with an Open Source Query Tool

Session Details

Claire Cocharan
2013 (Boston) Annual Meeting

Contributed Session
No Collaboration, No Trial: Why Collaborator Opinion Matters.

Session Details

Toshinori Murayama
2013 (Boston) Annual Meeting

Contributed Session
No-fault compensation to participants in un-notified clinical trials including stem cell study in Japan

Session Details

Syed Aakhtar Bokhari
2013 (Boston) Annual Meeting

Contributed Session
Non-surgical periodontal therapy reduces coronary heart disease risk markers: a randomized controlled trial

Session Details

John Kloke
2013 (Boston) Annual Meeting

Contributed Session
Nonparametric Covariate-Adjusted Hypothesis Tests Using R Estimation

Session Details

Maria Abraham
2013 (Boston) Annual Meeting

Contributed Session
ON THE ANALYSIS OF TUBERCULOSIS STUDIES WITH MISSING SPUTUM DATA

Session Details

Jennifer Talton
2013 (Boston) Annual Meeting

Contributed Session
ONLINE REQUEST SYSTEM FOR DATASETS, WRITING GROUPS, AND ANCILLARY STUDIES FOR THE SEARCH FOR DIABETES IN YOUTH STUDY

Session Details

Sherrie Whisler
2013 (Boston) Annual Meeting

Contributed Session
Overview Focus and Drilldown – Data Report Intelligence

Session Details

Katherine Freier
2013 (Boston) Annual Meeting

Contributed Session
Paint me a picture: Using visual data representation to summarize and explore data

Session Details

Ryan Ferguson
2013 (Boston) Annual Meeting

Contributed Session
Patient and Provider Acceptance of a Pragmatic Point-of-Care Pilot Study

Session Details

Russell Reeve
2013 (Boston) Annual Meeting

Contributed Session
PERSONALIZED AND ADAPTIVE TRIALS IN PHASE 2: COMPARISON OF DESIGNS

Session Details

Caitlyn Ellerbe
2013 (Boston) Annual Meeting

Contributed Session
Phase II/III Seamless Adaptive Dose Selection Design for Longitudinal Patient Data

Session Details

Huitian Lei
2013 (Boston) Annual Meeting

Contributed Session
Power analysis and Sample Size Calculation in Designing a SMART Trial for Building Dynamic Treatment Regimens

Session Details

Qian Wu
2013 (Boston) Annual Meeting

Contributed Session
Power analysis for seamless phase II/III designs with subpopulation selection and a change of survival, binary and normal endpoints

Session Details

Michele Melia
2013 (Boston) Annual Meeting

Contributed Session
POWER FOR THE PARTIALLY-PAIRED RANDOMIZATION DESIGN AS COMPARED WITH THE UNPAIRED DESIGN IN OPHTHALMOLOGICAL CLINICAL TRIALS

Session Details

Giada Morpurgo
2013 (Boston) Annual Meeting

Contributed Session
Practical considerations on medical device clinical trials in Georgia, a former Soviet Union country

Session Details

Mei Lu
2013 (Boston) Annual Meeting

Contributed Session
Pragmatic seamless design for an efficacy trial of asthma management with reduced cost.

Session Details

Shaun Treweek
2013 (Boston) Annual Meeting

Contributed Session
PRECIS-2: a tool to improve the applicability of randomised controlled trials

Session Details

Rick Morrison
2013 (Boston) Annual Meeting

Contributed Session
Pulling the Trigger on Risk-based Monitoring

Session Details

Jenny Donovan
2013 (Boston) Annual Meeting

Contributed Session
Q-QAT (Quanti-Qualitative Appointment Timing): A simple technique to elucidate key recruitment issues in RCTs

Session Details

Steven Ramsey
2013 (Boston) Annual Meeting

Contributed Session
Quality Control (QC) of Field-Based Pulmonary Function Testing (PFT) in the Gulf Long-Term Follow-up Study (GuLF STUDY)

Session Details

Kunaal Dhingra
2013 (Boston) Annual Meeting

Contributed Session
Quality of reporting of randomized clinical trials assessing probiotics for periodontal treatment. A systematic review on critical aspects in design, outcome assessment and clinical relevance

Session Details

Bruckner Thomas
2013 (Boston) Annual Meeting

Contributed Session
Quantile Regression

Session Details

Dean Gittleman
2013 (Boston) Annual Meeting

Contributed Session
Quantum Leap - Leveraging Real-time (Direct) Data-Entry to Increase Speed, Improve Quality, and Dramatically Reduce Costs

Session Details

Dennis Sweitzer
2013 (Boston) Annual Meeting

Contributed Session
Randomization Metrics: Jointly assessing predictability and efficiency loss in randomization designs

Session Details

Catherine Klersy
2013 (Boston) Annual Meeting

Contributed Session
Randomized phase II trials: are they entering research practice?

Session Details

Adam Glassman
2013 (Boston) Annual Meeting

Contributed Session
Randomizing Two Study Eyes from the Same Participant in Ophthalmic Clinical Trials

Session Details

Howard Collier
2013 (Boston) Annual Meeting

Contributed Session
Recommendations for future patient focussed trials addressing foot pain in systemic sclerosis

Session Details

R. Lakshmi Vishnuvajjala
2013 (Boston) Annual Meeting

Contributed Session
Regulatory Issues for Companion Diagnostics

Session Details

Paul Thompson
2013 (Boston) Annual Meeting

Contributed Session
Reproducible research methods with the SAS system and Microsoft Word

Session Details

David Swanson
2013 (Boston) Annual Meeting

Contributed Session
Research participant compensation: an issue of inference as well as ethics

Session Details

Kyra Garofolo
2013 (Boston) Annual Meeting

Contributed Session
Responder Analysis Outcomes in the Analysis of Acute Stroke Clinical Trials

Session Details

Mitchell Thomann
2013 (Boston) Annual Meeting

Contributed Session
Response-Adaptive Dose-Finding for Correlated Bivariate Data with Applications to Complement System Inhibition Studies

Session Details

Yuko Palesch
2013 (Boston) Annual Meeting

Contributed Session
Revisiting the question: To adjust or not to adjust for baseline covariates in randomization and/or in analysis of clinical trials?

Session Details

CHENGWU YANG
2013 (Boston) Annual Meeting

Contributed Session
RISK OF USING INSTRUMENTS IN INTERNATIONAL CLINICAL TRIALS: THE SCORES MAY NOT BE COMPARABLE ACROSS DIFFERENT COUNTRIES

Session Details

Wenle Zhao
2013 (Boston) Annual Meeting

Contributed Session
Risk-Based Monitoring Approach in Practice – Combination of Real-Time Central Monitoring and On-Site Source Document Verification

Session Details

Kyle Rudser
2013 (Boston) Annual Meeting

Contributed Session
Sample Size and Screening Size Trade Off in the Presence of Subgroups with Different Expected Treatment Effects

Session Details

Qiang Zhang
2013 (Boston) Annual Meeting

Contributed Session
Seamless phase II/III design for oncology trials with treatment selection and a change of survival endpoints

Session Details

Katharine Poole
2013 (Boston) Annual Meeting

Contributed Session
Signal Detection in Small Safety Databases

Session Details

Mohamed Mubasher
2013 (Boston) Annual Meeting

Contributed Session
SIMULATION-BASED EVALUATIONS OF METHODOLOGICAL ALTERNATIVES FOR RECYCLING RANDOMIZATION ASSIGNMENTS IN RANDOMIZED CLINICAL TRIALS (RCTs) OF ACUTE CONDITIONS (AC) WITH BRIEF FOLLOW UP

Session Details

Abress Gailor
2013 (Boston) Annual Meeting

Contributed Session
Smaller sample sizes for phase II trials based on exact tests

Session Details

Marisa De Rosa
2013 (Boston) Annual Meeting

Contributed Session
SMARTLAB: cloud computing for integration of centralized diagnostic laboratory data and patients data collection of research groups

Session Details

Evan Hempel
2013 (Boston) Annual Meeting

Contributed Session
SOCIAL MEDIA IN CLINICAL TRIAL RECRUITMENT AND RETENTION

Session Details

Keiko Ohta
2013 (Boston) Annual Meeting

Contributed Session
Standardized the way to management queries without relying data capturing or cleaning systems

Session Details

Louise Flanagan
2013 (Boston) Annual Meeting

Contributed Session
Standardizing Early Phase Trial Documentation and Processes

Session Details

Kousick Biswas
2013 (Boston) Annual Meeting

Contributed Session
Statistical Modeling of Recruitment for Multi-site Clinical Trials – Current Status

Session Details

Kathryn Mangoff
2013 (Boston) Annual Meeting

Contributed Session
STRATEGIES IMPLEMENTED TO ENSURE KNOWLEDGE TRANSFER

Session Details

Jitendra Ganju
2013 (Boston) Annual Meeting

Contributed Session
Strengthening Inferences from Analysis of Clinical Trial Data

Session Details

Mark McIlduff
2013 (Boston) Annual Meeting

Contributed Session
Succeeding as a Data Expert at an FDA Advisory Committee Meeting

Session Details

Dario Gregori
2013 (Boston) Annual Meeting

Contributed Session
Switching from non-inferiority to superiority in an adaptive setting: some notes

Session Details

Valerie Brueton
2013 (Boston) Annual Meeting

Contributed Session
Systematic review of strategies to reduce attrition in randomised trials

Session Details

Martin Tickle
2013 (Boston) Annual Meeting

Contributed Session
Systematic reviews or relevant randomised control trials, which should I believe? A dilemma for policy makers

Session Details

Lucy McParland
2013 (Boston) Annual Meeting

Contributed Session
THE BENEFITS AND CHALLENGES OF PERFORMING A CENTRAL REVIEW OF RESPONSE IN A CHRONIC LYMPHOCYTIC LEUKAEMIA TRIAL

Session Details

Lawrence Mbuagbaw
2013 (Boston) Annual Meeting

Contributed Session
The Cameroon Mobile Phone SMS (CAMPS) trial: a randomized trial of text messaging versus usual care for adherence to antiretroviral therapy

Session Details

Benjamin Saville
2013 (Boston) Annual Meeting

Contributed Session
The case for Bayesian predictive probabilities for interim monitoring of clinical trials

Session Details

Harlan Campbell
2013 (Boston) Annual Meeting

Contributed Session
The consequences of proportional-hazards based model selection

Session Details

Barbara Farrell
2013 (Boston) Annual Meeting

Contributed Session
The CORONIS Trial: International study of caesarean section surgical techniques – a randomised non-regular fractional, factorial trial

Session Details

James Peugh
2013 (Boston) Annual Meeting

Contributed Session
The Effect of Compliance Cut-Points on CACE Treatment Effect Estimates

Session Details

Sunny Chan
2013 (Boston) Annual Meeting

Contributed Session
The Effect of the Transition from Paper-based to Electronic Data Capture on Clinical Trial Metadata

Session Details

Norberto Pantoja-Galicia
2013 (Boston) Annual Meeting

Contributed Session
The Evaluation of Medical Diagnostic Tests in Clinical Studies using Local Likelihood Density estimation and ROC curves

Session Details

Christina Tittsworth
2013 (Boston) Annual Meeting

Contributed Session
The Evolution of the CRF Designer into a Data Manager

Session Details

Sue Ross
2013 (Boston) Annual Meeting

Contributed Session
The impact of commercial decisions on surgical progress: the case of TVT Secur

Session Details

Jason Stock
2013 (Boston) Annual Meeting

Contributed Session
The Importance of Innovative Data Management Practices for Clinical Registries

Session Details

Kimberly Lane
2013 (Boston) Annual Meeting

Contributed Session
The NIH Health Care Systems Research Collaboratory Distributed Research Network

Session Details

Haruko Yamamoto
2013 (Boston) Annual Meeting

Contributed Session
The path to a global clinical trial for acute stroke in Japan

Session Details

Steffanie Halberstadt
2013 (Boston) Annual Meeting

Contributed Session
The Potential of the Poincare Plot in the Search for Meaningful Measures of Heart Rate Variability

Session Details

Louise Flanagan
2013 (Boston) Annual Meeting

Contributed Session
The Risks and Benefits Associated with Running Investigator Led Early Phase Trials in Collaboration with Pharmaceutical and Charity Partners

Session Details

Aaron Perlmutter
2013 (Boston) Annual Meeting

Contributed Session
THE ROLE OF THE DATA MANAGER IN RISK-BASED MONITORING

Session Details

Tae-Yong Park
2013 (Boston) Annual Meeting

Contributed Session
The Sensitivity and Positive Predictive Value of Stroke Pattern Indicators in Traditional Korean Medicine: The Korean Standard Pattern Identification Questionnaire for Stroke

Session Details

Lea Drye
2013 (Boston) Annual Meeting

Contributed Session
The transforming of multicenter clinical trials to observational follow-up studies

Session Details

Haijing Qin
2013 (Boston) Annual Meeting

Contributed Session
THE USE OF A WEIGHTED COMBINATION OF THE LIFE-TABLE SURVIVAL ESTIMATES TO EVALUATE THE TREATMENT EFFECT IN A RANDOMIZED CLINICAL TRIAL WHEN THE PROPORTIONAL HAZARDS ASSUMPTION IS VIOLATED

Session Details

Aquila Farrell
2013 (Boston) Annual Meeting

Contributed Session
THE USE OF LOGS AND FORMS FOR THE TRACKING OF RT-CGM DEVICES IN THE CONCEPTT TRIAL

Session Details

Vivek Murthy
2013 (Boston) Annual Meeting

Contributed Session
The Use of Site Engagement Technology (SET) to Increase Patient Recruitment and Retention in Clinical Trials: a Case Study

Session Details

Farrah Mateen
2013 (Boston) Annual Meeting

Contributed Session
Titles versus Titles-and-Abstracts for Initial Screening of Articles for Systematic Reviews

Session Details

Holly Battenhouse
2013 (Boston) Annual Meeting

Contributed Session
Transitioning data management systems during an ongoing study: challenges, limitations and successes

Session Details

Catherine Dillon
2013 (Boston) Annual Meeting

Contributed Session
Trial Operation Errors: Sources and Prevention

Session Details

Stacey Slone
2013 (Boston) Annual Meeting

Contributed Session
Tricks of the Trade: Using SAS® to Analyze Irregularly Scheduled Clinical Data

Session Details

Jenny Donovan
2013 (Boston) Annual Meeting

Contributed Session
Understanding recruitment to randomised controlled trials: clinician and triallist perspectives

Session Details

Wenle Zhao
2013 (Boston) Annual Meeting

Contributed Session
Unintentional operation mistakes in emergency treatment trials and their impacts on trial results

Session Details

Annalisa Perna
2013 (Boston) Annual Meeting

Contributed Session
USE OF JOINT MODELING FOR LONGITUDINAL AND SURVIVAL DATA IN LONG-TERM RENAL CLINICAL TRIALS

Session Details

Heather Litman
2013 (Boston) Annual Meeting

Contributed Session
USE OF PROPENSITY SCORES TO COMBINE DATA FROM TWO SIMILAR CLINICAL TRIALS IN THE URINARY INCONTINENCE TREATMENT NETWORK

Session Details

Geraldine Baggs
2013 (Boston) Annual Meeting

Contributed Session
Using a Global Outcome (Sum of Pre-Post Ratings) in Ascertaining Effect of an Intervention

Session Details

Laurie McLeod
2013 (Boston) Annual Meeting

Contributed Session
USING A WEBPORTAL TO ENHANCE NETWORK COMMUNICATION

Session Details

John Norrie
2013 (Boston) Annual Meeting

Contributed Session
Using adaptive designs to build a behaviour change intervention in a complex intervention randomised controlled trial

Session Details

John Norrie
2013 (Boston) Annual Meeting

Contributed Session
Using adaptive designs to build a behavioural change intervention in a complex intervention randomised controlled trial

Session Details

Sarah Brown
2013 (Boston) Annual Meeting

Contributed Session
Using central review data in analyses of phase III trials

Session Details

Miguel Villarreal
2013 (Boston) Annual Meeting

Contributed Session
UTILIZING R FOR THE GRAPHICAL REPORTING OF ADVERSE EVENT CLINICAL TRIAL DATA TO FACILITATE DSMB REVIEW

Session Details

Patricia Davis
2013 (Boston) Annual Meeting

Contributed Session
WEB-BASED ADMINISTRATION AND TRACKING OF COGNITIVE DATA IN THE ACCORDION-MIND STUDY

Session Details

Shaun Treweek
2013 (Boston) Annual Meeting

Contributed Session
Web-based intervention modelling experiments: a way of exploring professional behaviour change interventions before a full-scale trial.

Session Details

Marion Campbell
2013 (Boston) Annual Meeting

Contributed Session
WHAT MAKES PEOPLE PARTICIPATE IN CLINICAL TRIALS? INSIGHTS FROM A META-ETHNOGRAPHY OF QUALITATIVE STUDIES

Session Details

Aenne Glass
2013 (Boston) Annual Meeting

Contributed Session
WHEN SURVIVAL CURVES CROSS … ADD A LANDMARK ANALYSIS: AN EXAMPLE FROM CARDIOLOGY

Session Details

Perkins John
2013 (Boston) Annual Meeting

Contributed Session
WHISpERer: Integrated Team Approach to Declarative Study Specification

Session Details

Jim Neaton
2012 (Miami) Annual Meeting

Special Presentation
Workshop - The Prevention and Treatment of Missing Data in Clinical Trials - Trial Stategies to Reduce the Frequency of Missing Data

Sue-Jane Wang
2012 (Miami) Annual Meeting

Special Presentation
Workshop - Biomarkers in Clinical Trials: General Principles for Study Design and Statistical Evaluation (1)-Overview of Biomarkers in Drug Development

Gene Pennello
2012 (Miami) Annual Meeting

Special Presentation
Workshop - Biomarkers in Clinical Trials: General Principles for Study Design and Statistical Evaluation (3)-Overview of Biomarkers in Device Development

Geert Molenberghs
2012 (Miami) Annual Meeting

Special Presentation
Workshop - Biomarkers in Clinical Trials: General Principles for Study Design and Statistical Evaluation (2)-Overview of Surrogate Endpoint Evaluation in Clinic Studies

Sumithra Mandrekar
2012 (Miami) Annual Meeting

Special Presentation
Workshop - Biomarkers in Clinical Trials: General Principles for Study Design and Statistical Evaluation (4)-Biomaker Trial Designs: Lessons from Real Trials

Larry Friedman
2012 (Miami) Annual Meeting

Trial of the Year Award
In Memory of Paul Meier & MOMS: Management of Myelomeningocele Study

Rick Chappell
2012 (Miami) Annual Meeting

Presidential Welcome

Wafaa El-Sadr
2012 (Miami) Annual Meeting

Curtis Meinert Lecture
Global HIV Prevention Trials

John P.A. Ioannidis
2012 (Miami) Annual Meeting

Founders Lecture
Designing and Dissecting the Geometry of Randomized Evidence

John Lachin
2012 (Miami) Annual Meeting

Fellows Presentation
Presentation of the Class of 2012 Fellows

Liza Dawson
2012 (Miami) Annual Meeting

Contributed Session

Session Details

Liza Dawson
2012 (Miami) Annual Meeting

Contributed Session
Post trial access to successful products: ethical and practical dilemmas

Session Details

Das Purkayastha
2012 (Miami) Annual Meeting

Contributed Session
A COX REGRESSION MODEL WITH ISOTONIC REGRESSORS WITH CHANGE-POINT PROBLEMS: ADDRESSING A CLINICAL QUESTION

Session Details

Zhibo Wang
2012 (Miami) Annual Meeting

Contributed Session
A Novel Statistical Software EWOC-NETS©TM for Extending Dose Escalation with Overdose Control (EWOC) to Fully Utilize All Toxicities in Cancer Phase I Clinical Trial

Session Details

Ming-Wen An
2012 (Miami) Annual Meeting

Contributed Session
A phase II design with direct assignment option for initial marker validation

Session Details

Ying Lu
2012 (Miami) Annual Meeting

Contributed Session
A Simple Bayesian Decision-Theoretic Design for Dose Finding Trials

Session Details

Aenne Glass
2012 (Miami) Annual Meeting

Contributed Session
A Study of Autologous Valve Replacement - CD133+ Stem Cell-plus-Fibrin Composite based Sprayed Cell Seeding for Intra-Operative Heart Valve Tissue Engineering

Session Details

Elizabeth Avery
2012 (Miami) Annual Meeting

Contributed Session
A Tailored Communication Platform for a Virtual Intervention Team

Session Details

Roger A'Hern
2012 (Miami) Annual Meeting

Contributed Session
A two stage Phase II design incorporating the possibility that the treatment effect may be restricted to a biomarker defined subgroup : investigation of a PARP inhibitor (olaparib) in castration resistant prostate cancer (CRPC).

Session Details

Yunzhi Lin
2012 (Miami) Annual Meeting

Contributed Session
A Unified Method for Balancing Continuous and Categorical Baseline Covariates in Randomized Clinical Trials

Session Details

Shazia Chaudhry
2012 (Miami) Annual Meeting

Contributed Session
Actual versus reported participant consent practices in cluster randomized trials: An international survey of trialists

Session Details

John Kairalla
2012 (Miami) Annual Meeting

Contributed Session
Adaptive designs for clinical comparative effectiveness research: Are we ready?

Session Details

Cynthia Stowe
2012 (Miami) Annual Meeting

Contributed Session
ADJUDICATING LIFE STUDY OUTCOMES THROUGH THE OUTCOME MANAGEMENT TOOL

Session Details

Aaron Perlmutter
2012 (Miami) Annual Meeting

Contributed Session
ADJUDICATION OF SAFETY OUTCOMES IN A WEB-BASED CLINICAL TRIAL MANAGEMENT SYSTEM

Session Details

Mary Crann BSN
2012 (Miami) Annual Meeting

Contributed Session
Adverse Event Reporting for Hematopoietic Stem Cell Transplant Studies

Session Details

Tibor Szentendrei
2012 (Miami) Annual Meeting

Contributed Session
AGING IN NUMBERS – NATIONAL HEALTH CARE TRENDS AND THE NATIONAL INSTITUTE ON AGING FUNDED CLINICAL TRIALS

Session Details

Robert Lew
2012 (Miami) Annual Meeting

Contributed Session
Alcoholism Treatment Studies: A Design Proposal to Improve Relevance

Session Details

Sunny Chan
2012 (Miami) Annual Meeting

Contributed Session
An Approach to Study Drug Management in Randomised Controlled Trials

Session Details

Patrick McDonnell
2012 (Miami) Annual Meeting

Contributed Session
An efficient and inexpensive system for the distribution and tracking of investigational medicinal products in clinical trials

Session Details

Thomas Bruckner
2012 (Miami) Annual Meeting

Contributed Session
Analysis of safety data using SAS

Session Details

Heidi Weiss
2012 (Miami) Annual Meeting

Contributed Session
Application of Different Randomized Phase II Trial Designs in a Breast Cancer Trial

Session Details

Adam Mendizabal
2012 (Miami) Annual Meeting

Contributed Session
Assessments for Safety and Efficacy in Cardiovascular Cell Therapy Clinical Trials

Session Details

Katherine Odem-Davis
2012 (Miami) Annual Meeting

Contributed Session
Bio-creep under serial use of non-inferiority trials designed for preservation of effect

Session Details

Yannan Jiang
2012 (Miami) Annual Meeting

Contributed Session
Can Exercise Enhance Smoking Cessation Outcomes? A Pragmatic Randomized Controlled Trial (Fit2Quit Study)

Session Details

Anisa Scott
2012 (Miami) Annual Meeting

Contributed Session
CDISC Data Standards Can Facilitate Composition of Adverse Event Narratives

Session Details

Erik Doffagne
2012 (Miami) Annual Meeting

Contributed Session
CENTRAL STATISTICAL MONITORING IN CLINICAL TRIALS

Session Details

Janice Pogue
2012 (Miami) Annual Meeting

Contributed Session
Central Statistical Monitoring: A Model to Predict Fraud in Clinical Trials

Session Details

Suzanne Breeman
2012 (Miami) Annual Meeting

Contributed Session
Challenges and implications of patient reported clinical outcomes for randomised controlled trials

Session Details

Jessica Vincent
2012 (Miami) Annual Meeting

Contributed Session
CHALLENGES AND STRATEGIES IN THE START-UP PHASE OF LARGE, INTERNATIONAL CLINICAL TRIALS IN CARDIAC SURGERY

Session Details

Jo Ann Hartline
2012 (Miami) Annual Meeting

Contributed Session
Challenges of Collecting Health Data and Maintaining Contact with an Aging Study Population

Session Details

Patti Shugarts
2012 (Miami) Annual Meeting

Contributed Session
Challenges of Creating and Managing Standards (Common Data Elements) for Use in Clinical Trials

Session Details

Heike Moenkemann
2012 (Miami) Annual Meeting

Contributed Session
Challenges of Developing Procedures for Serious Adverse Event Management and Reporting According to Regulatory Requirements in Clinical Trials with Medical Devices in Germany* * Granted by the German Federal Ministry of Research and education (BMBF Grants 01KN1106 and 01EZ0931) and by the “Technology, Methods, and Instructions for Networked Medical Research” (TMF e.V.)

Session Details

Jeannette Lee
2012 (Miami) Annual Meeting

Contributed Session
Challenges of Recruiting Women to a Clinical Trial of Treatment for Mucopurulent Cervicitis

Session Details

Trinh Hoac
2012 (Miami) Annual Meeting

Contributed Session
CHALLENGES TO TRANSITIONING FROM PAPER-BASED DATA COLLECTION TO ELECTRONIC DATA CAPTURE

Session Details

Yong Ma
2012 (Miami) Annual Meeting

Contributed Session
Change point identification with adaptive partitioning in Isotonic Regression for event-time data

Session Details

Sara Pressel
2012 (Miami) Annual Meeting

Contributed Session
Changing Directions in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial – Involving Outside Investigators in Manuscript Preparation and Ancillary Studies

Session Details

Maija Anderson
2012 (Miami) Annual Meeting

Contributed Session
Clinical Data Management of HIV/AIDS-Related Illnesses in HIV Clinical Trials: Challenges and Solutions

Session Details

Jochen Dress
2012 (Miami) Annual Meeting

Contributed Session
Clinical Trial Auditing in an electronic world: Do not risk you data - validate sufficiently

Session Details

Jennifer Talton
2012 (Miami) Annual Meeting

Contributed Session
CODING OPEN-ENDED RESPONSES: IDENTIFYING PROBLEMS AND SOLUTIONS

Session Details

Gustav Vella
2012 (Miami) Annual Meeting

Contributed Session
Collaborative Peer-Reviewing and Data Aggregation in Site Management with clinicalsite.org

Session Details

Brian Hutton
2012 (Miami) Annual Meeting

Contributed Session
Combining randomized and observational data using network meta-analysis to explore drug safety: the case of antifibrinolytics in cardiac surgery

Session Details

Toshinori Murayama
2012 (Miami) Annual Meeting

Contributed Session
Compensation for bodily damage to participants in un-notified clinical trials in Japan

Session Details

Talat Almukhtar
2012 (Miami) Annual Meeting

Contributed Session
Compliance Assessment For Eligibility In A 1-Year-Long Ophthalmic Clinical Trial Investigating Eye Drops

Session Details

Jiajun Liu
2012 (Miami) Annual Meeting

Contributed Session
Confidence Intervals for Difference of Correlated Proportions Based on Paired and Unpaired Data

Session Details

Kimberly Wiggins
2012 (Miami) Annual Meeting

Contributed Session
Conquering the challenges of conducting a trial's central initial training at an O'Hare hotel: The Blood Pressure in HemoDialysis (BID) pilot study experience

Session Details

Patricia Feeney
2012 (Miami) Annual Meeting

Contributed Session
CONSORT-LIKE FLOWCHARTS FOR PATIENT DISPOSITION IN DSMB REPORTS

Session Details

David Kong
2012 (Miami) Annual Meeting

Contributed Session
Contemporary Clinical Research in Adult Cardiovascular Medicine: A Perspective from ClinicalTrials.gov

Session Details

Laura Pyle
2012 (Miami) Annual Meeting

Contributed Session
Correlates and Characteristics of Stressful Life Events Reported by Adolescents with Type 2 Diabetes

Session Details

Madzouka Kokolo
2012 (Miami) Annual Meeting

Contributed Session
Could methods be a factor in early closures of HIV pre-exposure prophylaxis trials?

Session Details

Sherita Alai
2012 (Miami) Annual Meeting

Contributed Session
Creating a Public Use Data Set on an Existing Grid by a Dental Practice Based Research Network for Data Mining and Exchange

Session Details

Fawna Start
2012 (Miami) Annual Meeting

Contributed Session
CROSS TRAINING WITHIN A CLINICAL RESEARCH ORGANIZATION: DOES IT WORK OR DOES IT MUDDY THE WATERS?

Session Details

Pam Mangat
2012 (Miami) Annual Meeting

Contributed Session
DATA COLLECTION FOR AN AGING COHORT IN LONG-TERM CLINICAL TRIALS

Session Details

Danielle Smith
2012 (Miami) Annual Meeting

Contributed Session
Database Structure for Multiple Protocols Within a Project

Session Details

Sarah Gaussoin
2012 (Miami) Annual Meeting

Contributed Session
DEMOGRAPHIC AND HEALTH FACTORS ASSOCIATED WITH ENROLLMENT IN POST-TRIAL STUDIES: THE WOMEN’S HEALTH INITIATIVE HORMONE THERAPY TRIALS

Session Details

Keith Pauls
2012 (Miami) Annual Meeting

Contributed Session
Design of a Comprehensive Rule-Based, Real-Time Data Validation Function in a Web-Based Clinical Trial Management System

Session Details

Dennis Wallace
2012 (Miami) Annual Meeting

Contributed Session
Design of a Neonatal Intervention Based on Joint Evaluation of Efficacy and Toxicity

Session Details

Chengjie Xiong
2012 (Miami) Annual Meeting

Contributed Session
Designing clinical trials for testing disease-modifying agents on Alzheimer's disease

Session Details

Federica Zobec
2012 (Miami) Annual Meeting

Contributed Session
Designing Trials for Proving Efficay of Multifunctional Food: some Notes on the Need for Multiplicity Adjustment

Session Details

Johanna Sanchez
2012 (Miami) Annual Meeting

Contributed Session
DEVELOPING AN EFFECTIVE SITE FEASIBILITY QUESTIONNAIRE FOR THE SITE SELECTION PROCESS

Session Details

Jonathan Gibb
2012 (Miami) Annual Meeting

Contributed Session
Developing and implementing a laboratory information system (LIMS) to support trials in the United Kingdom

Session Details

Mary MacDonald
2012 (Miami) Annual Meeting

Contributed Session
Developing and implementing generic components to improve efficiency when building electronic data capture systems for clinical trials

Session Details

Cerisé Robinson
2012 (Miami) Annual Meeting

Contributed Session
Developing and Maintaining Standard Operating Procedures for a Multi-Trial Data Coordinating Centre

Session Details

John Norrie
2012 (Miami) Annual Meeting

Contributed Session
Developing Stop-Go criteria for pilot / feasibility studies to continue to full trials

Session Details

Margaret Byrne
2012 (Miami) Annual Meeting

Contributed Session
Development of a decision aid to improve minority cancer patients' decisions about participating in clinical trials

Session Details

Jill Francis
2012 (Miami) Annual Meeting

Contributed Session
DEVELOPMENT OF A TAXONOMY TO FACILITATE REPORTING OF BEHAVIOUR CHANGE TECHNIQUES, THE ‘ACTIVE INGREDIENTS’ OF BEHAVIOUR CHANGE INTERVENTIONS

Session Details

Pamela Marcus
2012 (Miami) Annual Meeting

Contributed Session
Did death certificates and a mortality review committee agree on lung cancer cause of death in the National Lung Screening Trial?

Session Details

Gladys McPherson
2012 (Miami) Annual Meeting

Contributed Session
DOES USING MINIMISATION MAKE A DIFFERENCE?: EMPIRICAL EVIDENCE FROM THREE MULTI-CENTRE STUDIES.

Session Details

Alice Sheffet
2012 (Miami) Annual Meeting

Contributed Session
Dollars and Sense: Effective Fiscal Management of the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)

Session Details

Wendy McBee
2012 (Miami) Annual Meeting

Contributed Session
EFFECTIVE MONITORING STRATEGIES IN A LONG-TERM CLINICAL TRIAL WITH VARYING LEVELS OF CLINIC STAFF KNOWLEDGE: THE AREDS2 EXPERIENCE

Session Details

Dalah Mason
2012 (Miami) Annual Meeting

Contributed Session
EFFECTIVE PROCESSING AND MONITORING OF CONTRACTS BETWEEN SPONSOR AND COLLABORATIVE CENTRES

Session Details

Derek Warren
2012 (Miami) Annual Meeting

Contributed Session
Electronic Health Record Systems for Medical Research project stakeholder management

Session Details

Cal Collins
2012 (Miami) Annual Meeting

Contributed Session
Electronic Patient Reported Data for Risk Screening in Primary Care Clinics using OpenClinica and CDISC ODM

Session Details

Renee Rees
2012 (Miami) Annual Meeting

Contributed Session
Elements of a Phase 3 IND Study Protocol – An FDA Statistical Perspective

Session Details

Marie Gantz
2012 (Miami) Annual Meeting

Contributed Session
Enrollment propensity weighting to assess the generalizability of a randomized clinical trial

Session Details

Asma Qureshi
2012 (Miami) Annual Meeting

Contributed Session
ENSURING SUCCESSFUL ADHERENCE TO STUDY REQUIREMENTS IN A MULTI-CENTRE STUDY

Session Details

Kathryn Spates
2012 (Miami) Annual Meeting

Contributed Session
EOSINOPHILIA AS A POTENTIAL SURROGATE FOR DEFINITIVE DIAGNOSIS OF STRONGYLOIDIASIS IN AN IMMIGRANT POPULATION AT A COMMUNITY CLINIC

Session Details

Dixie Ecklund
2012 (Miami) Annual Meeting

Contributed Session
Establishing a remote data entry system in a rural Trial community

Session Details

Robert Lindblad
2012 (Miami) Annual Meeting

Contributed Session
ESTIMATING DEATH RATES IN SUBSTANCE USE DISORDER CLINICAL TRIALS

Session Details

Ruediger Laubender
2012 (Miami) Annual Meeting

Contributed Session
Estimating subject-treatment effects from data generated in trials based on the parallel group design using covariates.

Session Details

Monica Taljaard
2012 (Miami) Annual Meeting

Contributed Session
ETHICAL ISSUES IN CLUSTER RANDOMIZED TRIALS: INTERNATIONAL SURVEY OF RESEARCH ETHICS CHAIRS

Session Details

Jami Jackson
2012 (Miami) Annual Meeting

Contributed Session
Evaluation of a New Institutional Clinical Research Monitoring Program for Investigator Initiated Studies

Session Details

Denise King
2012 (Miami) Annual Meeting

Contributed Session
Exception From Informed Consent (EFIC): Experiences from a Randomized Trial in Pediatric Emergency Patients

Session Details

Dena Cohen
2012 (Miami) Annual Meeting

Contributed Session
Experiences in Design and Implementation of Phase II Trials in Chronic Lymphocytic Leukaemia

Session Details

Hongjie Deng
2012 (Miami) Annual Meeting

Contributed Session
EXPLORATORY BIOMARKER ANALYSIS FOR RANDOMIZED PHASE 2 ONCOLOGY TRIALS

Session Details

Katherine Trigiani
2012 (Miami) Annual Meeting

Contributed Session
EXTENDED FOLLOW-UP IN MULTI-PHASE CLINICAL TRIALS

Session Details

Katrien Oude Rengerink
2012 (Miami) Annual Meeting

Contributed Session
Factors influencing recruitment in clinical trials

Session Details

Alan Cantor
2012 (Miami) Annual Meeting

Contributed Session
Factors that Affect Men’s Feelings about their Urination: Findings from a Multi-center Clinical Trial of Phytotherapy to Treat Lower Urinary Tract Symptoms

Session Details

Helen Fisher
2012 (Miami) Annual Meeting

Contributed Session
Factors that influence recruitment to longitudinal randomized controlled trials of disease prevention in early life

Session Details

Elizabeth Sweetman
2012 (Miami) Annual Meeting

Contributed Session
Failure to report protocol violations in clinical trials: a threat to internal validity?

Session Details

Jonathan Cook
2012 (Miami) Annual Meeting

Contributed Session
FORMAL METHODS FOR DETERMINING SAMPLE SIZE - SURVEY OF SCT MEMBERSHIP

Session Details

Gregor Stein
2012 (Miami) Annual Meeting

Contributed Session
Funding strategies for establishing surgical trial centers – experience and strategies

Session Details

YIJIE ZHOU
2012 (Miami) Annual Meeting

Contributed Session
Futility Boundary Design Based on Probability of Success

Session Details

Sherita Alai
2012 (Miami) Annual Meeting

Contributed Session
Future of Data Exchange and Data Mining: Posting Data on the Grid by a Dental Practice-Based Research Network

Session Details

Inga Rossion
2012 (Miami) Annual Meeting

Contributed Session
Good Clinical Practice Compliance in a Surgical Trial - Results of Monitoring and Audit

Session Details

Yassin Mazroui
2012 (Miami) Annual Meeting

Contributed Session
Group-based trajectory models in a clinical study in nutrition

Session Details

Karen Puehn
2012 (Miami) Annual Meeting

Contributed Session
GYNECOLGIC ONCOLOGY GROUP (GOG): MAKING A WEB-BASED CARDIFF TELEFORM GENERATED PDF PATIENT CLINICAL REPORTING FORM DYNAMIC WITH THE USE OF ADOBE FDF FILES

Session Details

Mark Garner
2012 (Miami) Annual Meeting

Contributed Session
HOW EFFECTIVE ARE PATIENT INFORMATION LEAFLETS? A FRAMEWORK AND METHODS FOR EVALUATION

Session Details

Sarah Brown
2012 (Miami) Annual Meeting

Contributed Session
IDENTIFYING OPTIMAL OUTCOME MEASURES FOR PHASE II TRIALS IN CANCER

Session Details

Yanqiu Weng
2012 (Miami) Annual Meeting

Contributed Session
Impact of safety monitoring on error rates of efficacy analyses in large phase III group sequential trials in life-threatening conditions with binary outcomes

Session Details

Jan Hickey
2012 (Miami) Annual Meeting

Contributed Session
Impacting a Clinical Trial’s Success by Integrating Regulations, Standards and Guidelines into Organizational Culture

Session Details

Marnie Bertolet
2012 (Miami) Annual Meeting

Contributed Session
Implementation and diagnostics for frequentist and Bayesian interim monitoring: sequential bounds and chain convergence in SAS

Session Details

Jennifer McCormack
2012 (Miami) Annual Meeting

Contributed Session
Implementation of a Drug Management Utility in a Multi-Site, Randomized, Double-Blinded Study

Session Details

Devin Hunt
2012 (Miami) Annual Meeting

Contributed Session
IMPLEMENTATION OF DIGITAL PEN TECHNOLOGY TO CAPTURE CLINICAL TRIAL DATA

Session Details

Emily Van Meter
2012 (Miami) Annual Meeting

Contributed Session
Implementation of likelihood-based continual reassessment method designs in dose finding trials

Session Details

Janice Kwok
2012 (Miami) Annual Meeting

Contributed Session
IMPROVING DATA MANAGEMENT THROUGH DATA TRANFER

Session Details

Daniel Jeffers
2012 (Miami) Annual Meeting

Contributed Session
Improving Data Quality Using Quality Improvement

Session Details

Gordon Doig
2012 (Miami) Annual Meeting

Contributed Session
Improving the reliability of web-based randomization using encrypted allocation information embedded into data elements

Session Details

Yuan Liu
2012 (Miami) Annual Meeting

Contributed Session
Incorporating Patient’s Characteristics in Cancer Phase I Clinical Trials using Time to DLT: Escalation with Overdose Control

Session Details

Supriya Parikh
2012 (Miami) Annual Meeting

Contributed Session
Increasing Institutional Oversight for Multicenter Protocols: An Institutional Office at Memorial Sloan-Kettering Cancer Center (MSKCC)

Session Details

Jennifer Gassman
2012 (Miami) Annual Meeting

Contributed Session
Integrating data from disparate sources into a central database in trial with hybrid funding: The Blood Pressure In HemoDialysis (BID) Pilot Study

Session Details

Michael Shi
2012 (Miami) Annual Meeting

Contributed Session
Integration of Data Management Systems for Large International Randomised Controlled Trials

Session Details

Zhengjia Chen Chen
2012 (Miami) Annual Meeting

Contributed Session
Interactive Software “Isotonic Design using Normalized Equivalent Toxicity Score (ID-NETS)” for Cancer Phase I Clinical Trials

Session Details

Michele Melia
2012 (Miami) Annual Meeting

Contributed Session
Interim Analysis with Sample Size Re-estimation for Binary Outcome in a Trial of Intravitreal Ranibizumab versus Saline Injection for Prevention of Vitrectomy in Eyes with Proliferative Diabetic Retinopathy and Vitreous Hemorrhage

Session Details

Mi Mi Ko
2012 (Miami) Annual Meeting

Contributed Session
Interobserver Reliability of Tongue Diagnosis Using Traditional Korean Medicine for Stroke Patients

Session Details

Alice Pressman
2012 (Miami) Annual Meeting

Contributed Session
Interpretation and results comparing frequentist and Bayesian interim monitoring: survival and continuous outcomes

Session Details

Brenda Brewer
2012 (Miami) Annual Meeting

Contributed Session
IS AN EVOLVING CHART AUDIT PLAN NECESSARY IN A LONG-TERM MULTI-CENTER TRIAL?

Session Details

Shamaila Anwar
2012 (Miami) Annual Meeting

Contributed Session
Issues to Consider in the Set-Up of Complex Intervention Trials in Vulnerable Populations

Session Details

Gabriele Dreier
2012 (Miami) Annual Meeting

Contributed Session
Knowledge transfer in clinical research: Do we know what is going on, do we know the results and are they transferred into practice?

Session Details

Diqiong Xie
2012 (Miami) Annual Meeting

Contributed Session
Large Sample Properties of Treatment Effect Estimators Using Propensity-Score Matching

Session Details

Yunzhi Lin
2012 (Miami) Annual Meeting

Contributed Session
Lasso Tree for Cancer Stage Grouping

Session Details

Siobhan Tobin
2012 (Miami) Annual Meeting

Contributed Session
LESSONS LEARNED: EFFECTIVE TRAINING STRATEGIES FOR ELECTRONIC DATA CAPTURING

Session Details

Imogene Grimes
2012 (Miami) Annual Meeting

Contributed Session
Leveraging Enrichment Design Methods to Improve the Likelihood of Success of Clinical Trials

Session Details

Yunzhi Lin
2012 (Miami) Annual Meeting

Contributed Session
Lin Yunzhi

Session Details

Chengwu Yang
2012 (Miami) Annual Meeting

Contributed Session
MEASUREMENT ISSUES IN THE HAMILTON RATING SCALE FOR DEPRESSION MAY CONCEAL POSITIVE FINDINGS IN CLINICAL TRIALS FOR MAJOR DEPRESSION

Session Details

Emily Crowe
2012 (Miami) Annual Meeting

Contributed Session
Methodology Matters: Spotlight on the Network of Hubs for Trials Methodology Research (HTMR) in the UK

Session Details

Nicole Foster
2012 (Miami) Annual Meeting

Contributed Session
METHODS FOR CALCULATING VARIABILITY OF THE INCREMENTAL COST EFFECTIVENESS RATIO IN COST-EFFECTIVENESS STUDIES

Session Details

Ivana Holloway
2012 (Miami) Annual Meeting

Contributed Session
Methods of analyses for a complex intervention cluster randomised stroke trial – looking for the goose that lays the golden egg

Session Details

Muthiah Vaduganathan
2012 (Miami) Annual Meeting

Contributed Session
MIDTERM BENEFITS OF PERIOPERATIVE STATIN THERAPY IN PATIENTS UNDERGOING ISOLATED VALVULAR HEART SURGERY: A PROPENSITY MATCHED ANALYSIS OF A 6-YEAR SURGICAL SERIES

Session Details

Margaret Byrne
2012 (Miami) Annual Meeting

Contributed Session
Minority cancer survivors' attitudes and experiences related to participation in cancer clinical trials

Session Details

Spencer Hey
2012 (Miami) Annual Meeting

Contributed Session
Modeling Robust Evidence in a Clinical Research Program

Session Details

Adrielle Houweling
2012 (Miami) Annual Meeting

Contributed Session
MONITORING BLOOD SAMPLE COLLECTION AND SHIPMENT IN A PUBLICLY FUNDED POST THROMBOTIC SYNDROME (PTS) RANDOMIZED CONTROLLED TRIAL (RCT)

Session Details

Eleftheria Kalaitzaki
2012 (Miami) Annual Meeting

Contributed Session
MONITORING RARE EVENTS IN A SINGLE ARM NON-INFERIORITY TRIAL (111; CRUK/09/011)

Session Details

Zhibao Mi
2012 (Miami) Annual Meeting

Contributed Session
Multiple Hypotheses Testing and Simultaneous Confidence Intervals for Multiple Adverse Event Assessment

Session Details

Lisa Wruck
2012 (Miami) Annual Meeting

Contributed Session
Must a randomized trial focus on hypothesis testing? -- Assessing risks and benefits of withdrawal from therapy when the acceptable risk margin is unclear

Session Details

Dixie Ecklund
2012 (Miami) Annual Meeting

Contributed Session
NeuroNEXT: Developing infrastructure for Phase 2 clinical trials in neurological disorders

Session Details

Jan Peterson
2012 (Miami) Annual Meeting

Contributed Session
NIAID AUDITING SERVICES PROGRAM (NASP): PROVIDING WORLDWIDE QUALITY ASSURANCE AUDITS OF DAIDS MONITORING FUNCTIONS

Session Details

Ryan Bailey
2012 (Miami) Annual Meeting

Contributed Session
Online Study Monitoring for Large Multi-Center Trials via a Data Dashboard

Session Details

JENNIFER ANDRINGA
2012 (Miami) Annual Meeting

Contributed Session
Optimizing Optical Character Recognition Software for High Quality Data

Session Details

Ainy Zahid
2012 (Miami) Annual Meeting

Contributed Session
OUTCOMES ADJUDICATION - THE PREPARATION PROCESS

Session Details

Helen Fisher
2012 (Miami) Annual Meeting

Contributed Session
Parental perception of a contract improves adherence in longitudinal randomized controlled trials of disease prevention in early life

Session Details

Jeannette Lee
2012 (Miami) Annual Meeting

Contributed Session
Participant Perception of Treatment Assignment is related to Symptom Severity in a Clinical Trial of Phytotherapy

Session Details

Jennifer Chadwick
2012 (Miami) Annual Meeting

Contributed Session
Partners in Research: Effective Collaboration between a National Clinical Trial (TODAY Study) and Oklahoma-Based Multi-Tribal Health Boards

Session Details

Carlo TOMINO
2012 (Miami) Annual Meeting

Contributed Session
Patients and clinical trials: how improve their participation ?

Session Details

Caroline Morgan
2012 (Miami) Annual Meeting

Contributed Session
Perception and use of adaptive designs in the industry and academia: persistent barriers and recommendations to overcome challenges

Session Details

Joan Hilner
2012 (Miami) Annual Meeting

Contributed Session
Planning for the End: The Type 1 Diabetes Genetics Consortium (T1DGC)

Session Details

Elizabeth Paynter
2012 (Miami) Annual Meeting

Contributed Session
POSTING STUDY RESULTS TO CLINICALTRIALS.GOV: EFFECTIVE TOOLS AND LESSONS LEARNED

Session Details

Katrien Oude Rengerink
2012 (Miami) Annual Meeting

Contributed Session
Pregnant women's views about participation in trials – a qualitative study.

Session Details

Kati Stoermer
2012 (Miami) Annual Meeting

Contributed Session
Provision of Coverage Analysis in Multi-Site Clinical Trials Aids All Sites and Particularly Smaller, Community-Based Practices

Session Details

Doerthe Seidel
2012 (Miami) Annual Meeting

Contributed Session
Randomised controlled trials with the purpose to gain reimbursement for medical devices in Germany - responsible institutions and trial design requirements for the implementation of study results in the decision-making processes using the example of negative pressure wound therapy

Session Details

James Anderson
2012 (Miami) Annual Meeting

Contributed Session
RANDOMIZED DECISION DESIGNS WHEN THE NUMBER OF AVAILABLE SUBJECTS PRECLUDES A MORE STANDARD STUDY DESIGN

Session Details

Yunda Huang
2012 (Miami) Annual Meeting

Contributed Session
Ranking and Selection Design of a Phase IIa HIV Vaccine Clinical Trial in China with Three Active Arms and Multiple Endpoints of Interest

Session Details

Melissa Jovellanos
2012 (Miami) Annual Meeting

Contributed Session
RECORDING CLINICAL INTERVIEWS AND THE REVOLUTION OF DIGITAL TECHNOLOGY

Session Details

Andrea Zombeck
2012 (Miami) Annual Meeting

Contributed Session
RECRUITING AND RETAINING MINORITY SUBJECTS FOR GENETIC RESEARCH: CHALLENGES AND SUCCESSES

Session Details

Lisa Mighton
2012 (Miami) Annual Meeting

Contributed Session
Recruiting Patients for an Interdisciplinary, Multi-center International Randomized Clinical Trial: Barriers and Strategies, Bypass Angiographic Revascularization Investigation 2 Diabetes Trial (BARI 2D)

Session Details

Susan Chrolavicius
2012 (Miami) Annual Meeting

Contributed Session
RECRUITMENT AND RETENTION OF TRIAL SUBJECTS IN THE 21st CENTURY: INSIGHTS FROM EXPERIENCE FOM CONDUCTING SEVERAL RECENT LARGE INTERNATIONAL TRIALS IN CARDIOLOGY

Session Details

Margaret Michel
2012 (Miami) Annual Meeting

Contributed Session
Reducing Barriers to Cancer Care and Increasing Access to Clinical Research Participation at the Ralph Lauren Center for Cancer Care and Prevention

Session Details

Mae Gordon
2012 (Miami) Annual Meeting

Contributed Session
REDUCING SURVEILLANCE BIAS IN ADVERSE EVENTS REPORTING IN AN UNMASKED TREATMENT TRIAL

Session Details

Miguel Villarreal
2012 (Miami) Annual Meeting

Contributed Session
REPEAT PARTICIPANTS IN CLINICAL RESEARCH: AN OVERLOOKED SUB-POPULATION? EVIDENCE FROM 20 YEARS OF INNER CITY ASTHMA CONSORTIUM (ICAC) STUDIES

Session Details

Paul Thompson
2012 (Miami) Annual Meeting

Contributed Session
Reproducible Research and Clinical Trials

Session Details

Melissa Brown
2012 (Miami) Annual Meeting

Contributed Session
RESOLVING THE CONFLICT: SPONSOR-INVESTIGATORS AND THE ETHICAL CONCERN BEHIND THE CONSENT PROCESS

Session Details

Milena Silverman
2012 (Miami) Annual Meeting

Contributed Session
RESPONDING TO THE GROWING NEED FOR ALTERNATIVE PLATFORMS FOR COLLECTING CLINICAL RESEARCH DATA

Session Details

Shamalia Anwar
2012 (Miami) Annual Meeting

Contributed Session
Responsive Recruitment Strategies to Maximise Recruitment: experience from national UK Stroke Trials

Session Details

Dana Keane
2012 (Miami) Annual Meeting

Contributed Session
Results of remote monitoring techniques for multi-center ophthalmic imaging trials

Session Details

Liz Graham
2012 (Miami) Annual Meeting

Contributed Session
Risk Management of Non-CTIMP Trials: focus on complex intervention trials

Session Details

Patti Shugarts
2012 (Miami) Annual Meeting

Contributed Session
Risk-based Approach to Monitoring: The Way of the Future

Session Details

Lisa Murphy
2012 (Miami) Annual Meeting

Contributed Session
Role of Glucocorticoid Receptor SNPs in Receptor Function and Metabolic Disease

Session Details

Amal Alhefdhi
2012 (Miami) Annual Meeting

Contributed Session
Role of Vitamin D and/or Calcium Routine Supplementation in Preventing Hypocalcemia Post-thyroidectomy- Meta-analysis Review

Session Details

Alex Wright-Hughes
2012 (Miami) Annual Meeting

Contributed Session
Routine Data – is it good enough for trials?

Session Details

John Norrie
2012 (Miami) Annual Meeting

Contributed Session
Safety in non-drug randomised complex intervention trials

Session Details

Ivana Holloway
2012 (Miami) Annual Meeting

Contributed Session
Sample size considerations in cluster randomised trials with unequal clusters – experience from two UK stroke rehabilitation trials

Session Details

Zhiying You
2012 (Miami) Annual Meeting

Contributed Session
SAMPLE SIZE FOR PRE-POST COMPARISON WITH INTERVENTION DELIVERED TO CLUSTER

Session Details

Lindsey Ho
2012 (Miami) Annual Meeting

Contributed Session
Sampling Considerations for Genetic Associations in the Environmental Polymorphisms Registry (EPR)

Session Details

Levent Bayman
2012 (Miami) Annual Meeting

Contributed Session
SAS Enterprise Guide and Graphics in Clinical Trials

Session Details

Laura Magee
2012 (Miami) Annual Meeting

Contributed Session
Serious unexpected events in an obstetric clinical trial – definitional challenges

Session Details

Claire Cochran
2012 (Miami) Annual Meeting

Contributed Session
SHRINKING THE GLOBAL VILLAGE: THE CHALLENGES OF TRIAL MANAGEMENT IN AN INTERNATIONAL MULTI-CENTRE TRIAL

Session Details

Jinesh Shah
2012 (Miami) Annual Meeting

Contributed Session
Simulation studies to inform the selection of statistical monitoring boundaries for a stepwise Non-inferiority / Superiority Trial.

Session Details

aditi sapre
2012 (Miami) Annual Meeting

Contributed Session
Some strategies for defining non-inferiority bounds in active-controlled trials with no placebo-controlled data for the active comparator

Session Details

Catherine Klersy
2012 (Miami) Annual Meeting

Contributed Session
Soundness of evidence derived from metanalysis of high quality observational studies. A case in Cardiology.

Session Details

Henian Chen
2012 (Miami) Annual Meeting

Contributed Session
STANDARD DEVIATION CHOICE AND SAMPLE SIZE CALCULATION IN CLINICAL TRIALS

Session Details

Alice Henning
2012 (Miami) Annual Meeting

Contributed Session
Starting a Genetic Repository

Session Details

Imogene Grimes
2012 (Miami) Annual Meeting

Contributed Session
Statistical Considerations for Analysis of Progression-Free Survival Data

Session Details

Adam Omidpanah
2012 (Miami) Annual Meeting

Contributed Session
Strategies for handling incomplete data in the evaluation of diagnostic tests and risk predictions

Session Details

Mariam Saleem
2012 (Miami) Annual Meeting

Contributed Session
STRATEGIES IMPLEMENTED FOR SUCCESSFUL DATA RETRIEVAL AND ACCURACY IN A LONG TERM FOLLOW-UP STUDY

Session Details

Kathryn Mangoff
2012 (Miami) Annual Meeting

Contributed Session
STRATEGIES IMPLEMENTED TO ENSURE DATA ACCURACY FOR FINAL ANALYSIS

Session Details

Shamaila Anwar
2012 (Miami) Annual Meeting

Contributed Session
Strategies to maximise response rates to postal questionnaires in pragmatic trials involving elderly stroke patients and their caregivers

Session Details

Kelci Miclaus
2012 (Miami) Annual Meeting

Contributed Session
Streamlined Drug Induced Liver Injury Detection with Hy’s Law and Temporal Visualization

Session Details

Pam Mangat
2012 (Miami) Annual Meeting

Contributed Session
STREAMLINING DATA COLLECTION AND FLOW FOR CENTRAL UNITS IN LARGE MULTI-CENTER CLINICAL TRIALS

Session Details

Danielle Chandler
2012 (Miami) Annual Meeting

Contributed Session
STUDY DESIGN ISSUES IN A RANDOMIZED TRIAL COMPARING THE COST-EFFECTIVENESS OF IMMEDIATE TREATMENT VS. OBSERVATION/DEFERRED TREATMENT APPROACHES

Session Details

Richard Zink
2012 (Miami) Annual Meeting

Contributed Session
Summarizing the Incidence of Adverse Events Using Volcano Plots and Time Windows

Session Details

Mireya Diaz
2012 (Miami) Annual Meeting

Contributed Session
Supplementing the design of comparative binary outcome trials with sequential meta-analyses

Session Details

Tulay Koru-Sengul
2012 (Miami) Annual Meeting

Contributed Session
Survey of Commonly Used Analytical Methods for Analyzing Biomarkers with Limit of Detection

Session Details

Roxanne Ward
2012 (Miami) Annual Meeting

Contributed Session
Survey of the Current Beliefs and Attitudes of the Canadian Critical Care Trials Group Regarding Source Data Verification

Session Details

Marisa De Rosa
2012 (Miami) Annual Meeting

Contributed Session
Technologies supporting Clinical Research in resource poor settings

Session Details

Elizabeth Wright
2012 (Miami) Annual Meeting

Contributed Session
THE CLINICALTRIALS.GOV RESULTS DATABASE AS A RESOURCE FOR DESIGNING CLINICAL TRIALS

Session Details

Paula Williamson
2012 (Miami) Annual Meeting

Contributed Session
The COMET (Core Outcome Measures in Effectiveness Trials) Initiative

Session Details

Sharon Kean
2012 (Miami) Annual Meeting

Contributed Session
The Development of a safe haven to allow access to routinely collected healthcare datasets for use in clinical trials

Session Details

Robert Annechiarico
2012 (Miami) Annual Meeting

Contributed Session
The Future of the caBIG® Clinical Trials Software Development Mission: Engaging the Open Source Community

Session Details

Elizabeth Thom
2012 (Miami) Annual Meeting

Contributed Session
THE GLOBAL OBSTETRICS NETWORK (GONet): AN INTERNATIONAL COLLABORATIVE GROUP

Session Details

Carlo TOMINO
2012 (Miami) Annual Meeting

Contributed Session
The Italian Register for Clinical Trials; the “Unique” e-acces for regulatory, submission and management of clinical trials

Session Details

Lea Harvin
2012 (Miami) Annual Meeting

Contributed Session
THE LIFE STUDY OUTCOMES MANAGEMENT TOOL

Session Details

maiken pontoppidan
2012 (Miami) Annual Meeting

Contributed Session
THE LONG ROAD TO START UP RCTs WITHIN THE SOCIAL SERVICES INTERVENTIONS IN DENMARK

Session Details

Yuan Ji
2012 (Miami) Annual Meeting

Contributed Session
The modified toxicity probability interval (mTPI) method for phase I dose-finding trials

Session Details

Fiona Simpson
2012 (Miami) Annual Meeting

Contributed Session
The novel use of site selection surveys to improve sub-optimal recruitment

Session Details

Wai Yin Yeung
2012 (Miami) Annual Meeting

Contributed Session
The power of covariate-adaptive randomization schemes in clinical trials

Session Details

Carole Federico
2012 (Miami) Annual Meeting

Contributed Session
The Publication of Preclinical Evidence Supporting Translation of New Drugs: An Empirical Analysis

Session Details

Nancy Payte
2012 (Miami) Annual Meeting

Contributed Session
The Quality of Medical Record Abstraction in a Multi-Center Study: The Importance of Training

Session Details

Bradford Hirsch
2012 (Miami) Annual Meeting

Contributed Session
THE STATE OF THE ONCOLOGY TRIALS PORTFOLIO: INSIGHTS FROM CLINICALTRIALS.GOV

Session Details

Fiona Simpson
2012 (Miami) Annual Meeting

Contributed Session
The Use of a Multifaceted Clinical Trial Implementation and Education Strategy to Minimise Major Protocol Violations

Session Details

Elizabeth Sweetman
2012 (Miami) Annual Meeting

Contributed Session
The use of Adult Learning Theory in critical care clinical trials site initiation meetings improves confidence in new research skills and techniques and may enhance study conduct.

Session Details

Colleen Allen
2012 (Miami) Annual Meeting

Contributed Session
The Use of Ancillary Data Capture Systems in Clinical Trials

Session Details

BO YANG
2012 (Miami) Annual Meeting

Contributed Session
The Use of Bayesian Predictive Distribution in Clinical Trials

Session Details

Katherine Kirkwood
2012 (Miami) Annual Meeting

Contributed Session
The VACS Index Score as an Alternative Endpoint in HIV/AIDS Studies

Session Details

Sherrie Schenning
2012 (Miami) Annual Meeting

Contributed Session
TRACKING OF REGULATORY DOCUMENTS IN A LARGE CLINICAL TRIAL, THE AGE-RELATED EYE DISEASE STUDY 2 (AREDS2)

Session Details

Heike Moenkemann
2012 (Miami) Annual Meeting

Contributed Session
Transformation of regulatory requirements into a Training Curriculum for Investigational Site Teams of Clinical Trials with Medical Devices in Germany* * Granted by the German Federal Ministry of Research and Education, Germany, BMBF Grant 01KN1106

Session Details

Christen Long
2012 (Miami) Annual Meeting

Contributed Session
Transitioning an adolescent cohort from a randomized clinical trial (TODAY) to a post-intervention follow-up study (TODAY2)

Session Details

Caroline Kim
2012 (Miami) Annual Meeting

Contributed Session
TRANSITIONING PAPER TO ELECTRONIC CASE REPORT FORMS MID-STUDY FROM ONE CLINICAL RESEARCH ORGANIZATION TO ANOTHER

Session Details

Yunda Huang
2012 (Miami) Annual Meeting

Contributed Session
US-China Collaborations on the Design of China’s first Phase IIb HIV Vaccine Efficacy Trial

Session Details

Gordon Doig
2012 (Miami) Annual Meeting

Contributed Session
Use of a of a formal study run-in phase to reduce recruitment errors in a multi-centre randomized controlled trial: Is quality better than quantity?

Session Details

Peter Calhoun
2012 (Miami) Annual Meeting

Contributed Session
Use of Barnard’s Test as a More Powerful Alternative to Fisher’s Exact Test

Session Details

Devon Check
2012 (Miami) Annual Meeting

Contributed Session
Use of Central IRBs for Multicenter Clinical Trials

Session Details

Gary Johnson
2012 (Miami) Annual Meeting

Contributed Session
Use of Historical Controls in Assessing Long-Term Zoster Vaccine Efficacy

Session Details

Nicola Greenlaw
2012 (Miami) Annual Meeting

Contributed Session
Use of routinely collected data within primary care medical centre-based trials

Session Details

Tamara Olinger
2012 (Miami) Annual Meeting

Session Details

Ann Zauber
2012 (Miami) Annual Meeting

Contributed Session
Using randomized controlled trials in colorectal cancer screening to derive the unobserable undelrying dwell time of adenoma to carcinoma in the natural history of colorectal cancer- USE NORCAPP and dwell time OR A novel hypthesis on the sensitivty of FOBT; Results of a joint analysis of three randomized trials on Fecal Occult Blood Test Screening for Colorectal Cancer

Session Details

Darrin Harris
2012 (Miami) Annual Meeting

Contributed Session
Utilizing a Web-Based Telephone Call Tracking System in the Collection of Cognitive Data

Session Details

John Hermos
2012 (Miami) Annual Meeting

Contributed Session
Web-based Intervention for Returning Veterans with Risky Alcohol Use and Posttraumatic Stress Symptoms

Session Details

Kelley Kidwell
2012 (Miami) Annual Meeting

Contributed Session
Weighted Log-rank Statistic to Compare Shared-Path Adaptive Treatment Strategies

Session Details

Katrien Oude Rengerink
2012 (Miami) Annual Meeting

Contributed Session
What influences patient participation in randomized controlled trials of surgical interventions?

Session Details

Nicola McCleary
2012 (Miami) Annual Meeting

Contributed Session
WHICH COMPONENTS OF INTERVENTIONS ARE REPORTED IN TITLES AND ABSTRACTS? A SYSTEMATIC REVIEW TO COMPARE REPORTING PRACTICES FOR PHARMACOLOGIC AND NON-PHARMACOLOGIC INTERVENTIONS

Session Details

Bingyan Wu
2012 (Miami) Annual Meeting

Contributed Session
WHO can RECIST?: The Evolution of Solid Tumor Response Criteria

Session Details

Katrien Oude Rengerink
2012 (Miami) Annual Meeting

Contributed Session
Why do some centers recruit better than others? - an analysis of recruitment rates in 17 trials in Obstetrics and Gynecology.

Session Details

Allison Caban-Holt
2012 (Miami) Annual Meeting

Contributed Session
Working with at-risk populations

Session Details

Yves Rosenberg
2011 (Vancouver) Annual Meeting

Special Presentation
Workshop - Essentials of Randomized Clinical Trials - (1) Introduction to Randomized Clinical Trials

Michele Melia
2011 (Vancouver) Annual Meeting

Special Presentation
Workshop - Essentials of Randomized Clinical Trials - (4) Treatment Allocation

Laura Lovato
2011 (Vancouver) Annual Meeting

Special Presentation
Workshop - Essentials of Randomized Clinical Trials - (2) Data Collection, Reporting, and Quality Control Issues

Susan Halabi
2011 (Vancouver) Annual Meeting

Special Presentation
Workshop - Essentials of Randomized Clinical Trials - (6) General Statistical Concepts

Susan Halabi
2011 (Vancouver) Annual Meeting

Special Presentation
Workshop - Essentials of Randomized Clinical Trials - (5) Choice of Endpoints

Dixie Ecklund
2011 (Vancouver) Annual Meeting

Special Presentation
Workshop - Essentials of Randomized Clinical Trials - (3) Project Management in Clinical Trials

Bob Byington
2011 (Vancouver) Annual Meeting

Presidential Welcome

Prasanta Tripathy
2011 (Vancouver) Annual Meeting

Trial of the Year Award
The Ekjut Trial in Jharkhand and Orissa

Johan Karlberg
2011 (Vancouver) Annual Meeting

Founders Lecture
Asian Clinical Trial Trends by Sponsor, Trial Phase, Disease Area, Country

Anushka Patel
2011 (Vancouver) Annual Meeting

Curtis Meinert Lecture
Crouching Tiger, Hidden Dragon: Clinical Trials in Asia

Meihua Wang
2011 (Vancouver) Annual Meeting

Contributed Session
The impact of association between endpoints on performance in seamless phase II/III clinical trial designs

Session Details

Virginia Filiaci
2011 (Vancouver) Annual Meeting

Contributed Session
A biomarker-based adaptive two-stage randomized phase II study design

Session Details

Tony Panzarella
2011 (Vancouver) Annual Meeting

Contributed Session
A case for using absolute treatment differences when designing a clinical trial with a dichotomous outcome

Session Details

Elizabeth Thom
2011 (Vancouver) Annual Meeting

Contributed Session
A CENTER PERFORMANCE ASSESSMENT TOOL IN A MULTICENTER CLINICAL TRIALS NETWORK

Session Details

Jennifer Rosenbaum
2011 (Vancouver) Annual Meeting

Contributed Session
A COMPLEX WEB-BASED STRUCTURE FOR COORDINATING REVIEW AND TRACKING PROGRESS OF ANCILLARY STUDIES IN THE NATIONAL LUNG SCREENING TRIAL

Session Details

Le Kang
2011 (Vancouver) Annual Meeting

Contributed Session
A latent class model analysis using the Monte Carlo EM algorithm to assess accuracy of diagnostic tests of cervical neoplasia in women with atypical glandular cells of undetermined significance

Session Details

Caroline Boulind
2011 (Vancouver) Annual Meeting

Contributed Session
A mixed methods study to assess the success of blinding in surgical randomised controlled trials

Session Details

Trisha Boekhoudt
2011 (Vancouver) Annual Meeting

Contributed Session
A MODEL FOR CAPITATION PAYMENT IN A MULTICENTER CLINICAL TRIALS NETWORK

Session Details

Trinh Hoac
2011 (Vancouver) Annual Meeting

Contributed Session
A Multifaceted Approach to the Query Process

Session Details

David Kerr
2011 (Vancouver) Annual Meeting

Contributed Session
A New Tool for Flagging Adverse Events of Potential Clinical Interest

Session Details

Jo Ann Hartline
2011 (Vancouver) Annual Meeting

Contributed Session
A Secure Website for Participant Submission of Follow-up Data

Session Details

Lemuel Waitman
2011 (Vancouver) Annual Meeting

Contributed Session
A Streamlined Process for Electronic Case Report Form Development

Session Details

Rui Qin
2011 (Vancouver) Annual Meeting

Contributed Session
A Toxicity-adaptive Isotonic Design for combination therapy in Oncology

Session Details

Kathy Clingan
2011 (Vancouver) Annual Meeting

Contributed Session
A UNIQUE WEB-BASED TOOL FOR PERFORMING AND TRACKING DATA QUALITY ASSURANCE TASKS IN A MULTI-CENTER STUDY

Session Details

Daniel Rosenberg
2011 (Vancouver) Annual Meeting

Contributed Session
A Web-Based Study Product Verification Utility for Blinded Treatment of Food Allergy Subjects

Session Details

Andrea Grunow
2011 (Vancouver) Annual Meeting

Contributed Session
Academic trials and the challenge of sponsor responsibility

Session Details

Sunny Chan
2011 (Vancouver) Annual Meeting

Contributed Session
Achieving Complete and Clean Data in Preparation for Data Analysis

Session Details

Annie Green Howard
2011 (Vancouver) Annual Meeting

Contributed Session
Action to Control Cardiovascular Risk in Diabetes (ACCORD) Home Blood Pressure Study Results

Session Details

Christoph Seiler
2011 (Vancouver) Annual Meeting

Contributed Session
ACTIVE MONITORING OF PATIENT RECRUITMENT IN SURGICAL TRIALS

Session Details

Christopher Coffey
2011 (Vancouver) Annual Meeting

Contributed Session
Adaptive Design for Clinical Trials: Perspectives from a Workshop

Session Details

Michael Mi
2011 (Vancouver) Annual Meeting

Contributed Session
Adaptive design modifications to the sequential parallel comparison design for clinical trials

Session Details

Jennifer Gassman
2011 (Vancouver) Annual Meeting

Contributed Session
Adding cohort follow up to the end of a randomized trial

Session Details

Mae Gordon
2011 (Vancouver) Annual Meeting

Contributed Session
ADJUDICATION OF VISUAL FIELD ENDPOINTS IN THE OCULAR HYPERTENSION TREATMENT STUDY (OHTS)

Session Details

Sue Ross
2011 (Vancouver) Annual Meeting

Contributed Session
Adopting new surgical devices into clinical practice: contrasting roles of HTA organisations in Canada

Session Details

Jing Huang
2011 (Vancouver) Annual Meeting

Contributed Session
Adverse Event Signal Detection: Overall comparisons, Future Projections and False Discoveries

Session Details

Mark Schactman
2011 (Vancouver) Annual Meeting

Contributed Session
An assessment of different methods for calculating confidence intervals on proportions

Session Details

Jennifer Rosenbaum
2011 (Vancouver) Annual Meeting

Contributed Session
AN EFFICIENT WEB-BASED APPROACH TO MANAGING A COMPLEX CAUSE OF DEATH REVIEW PROCESS

Session Details

Wendy McBee
2011 (Vancouver) Annual Meeting

Contributed Session
AN EXAMINATION OF SITE VISIT DATA AUDIT RESULTS COMPILED DURING THE INITIAL FOUR YEARS OF A LONG-TERM CLINICAL TRIAL

Session Details

Ellen Peskin
2011 (Vancouver) Annual Meeting

Contributed Session
AN INTEGRATED, INTERACTIVE WEB-BASED STUDY CERTIFICATION SYSTEM

Session Details

Kristin Snow
2011 (Vancouver) Annual Meeting

Contributed Session
AN ORGANIZATIONAL STRUCTURE TO MANAGE ANALYSES AND MANUSCRIPT DEVELOPMENT IN THE HEPATITIS C ANTIVIRAL LONG-TERM TREATMENT AGAINST CIRRHOSIS (HALT-C) TRIAL

Session Details

Jiajun Liu
2011 (Vancouver) Annual Meeting

Contributed Session
Analysis of Incomplete Non-Normal Longitudinal Lipid Data

Session Details

Marla Husnik
2011 (Vancouver) Annual Meeting

Contributed Session
Analysis of Relatedness Terminology for Adverse Effects in a Phase I Clinical Trial

Session Details

Abigail Matthews
2011 (Vancouver) Annual Meeting

Contributed Session
Application of Excess Zero Methodology to Oral Health-Related Quality of Life: PEARL Network Findings

Session Details

Mark Jitlal
2011 (Vancouver) Annual Meeting

Contributed Session
Applying futility analysis to several real clinical trials

Session Details

Sarah Gaussoin
2011 (Vancouver) Annual Meeting

Contributed Session
ASCERTAINING DEMENTIA RELATED OUTCOMES FOR DECEASED OR PROXY-DEPENDENT PARTICIPANTS: AN OVERVIEW OF WHIMS SUPPLEMENTAL CASE ASCERTAINMENT PROTOCOL (SCAP)

Session Details

Lukasz Krzych
2011 (Vancouver) Annual Meeting

Contributed Session
ASSESSMENT OF DATA QUALITY IN AN INTERNATIONAL MULTI-CENTRE RANDOMISED TRIAL OF CORONARY ARTERY SURGERY

Session Details

William Elgie
2011 (Vancouver) Annual Meeting

Contributed Session
Automated Drug Ordering in a Cooperative Group Setting

Session Details

Trisha Boekhoudt
2011 (Vancouver) Annual Meeting

Contributed Session
bla

Session Details

Elizabeth Avery
2011 (Vancouver) Annual Meeting

Contributed Session
BLINDING IN RANDOMIZED BEHAVIORAL CLINICAL TRIALS

Session Details

Susan Assmann
2011 (Vancouver) Annual Meeting

Contributed Session
Calculating and Presenting Conditional Power at Interim Looks for an Adjudicated Time-to-Event Outcome

Session Details

Julie Bakobaki
2011 (Vancouver) Annual Meeting

Contributed Session
Can central monitoring techniques identify on-site monitoring findings? A review of findings from selected monitoring reports in a phase III trial.

Session Details

Jamie Brehaut
2011 (Vancouver) Annual Meeting

Contributed Session
Can patient decision aids help trial participants? A new approach to informed consent for clinical research.

Session Details

PETER YEGON
2011 (Vancouver) Annual Meeting

Contributed Session
Capitalizing Upon Local Capacity and Experience for Clinical Research Data Management in Resource Limiting Settings: the Kericho CLADE Study

Session Details

Amy Kirkwood
2011 (Vancouver) Annual Meeting

Contributed Session
Central statistical monitoring in clinical trials

Session Details

Martina Mueller
2011 (Vancouver) Annual Meeting

Contributed Session
CHALLENGES AND LESSONS LEARNED IN A CLUSTER RANDOMIZED TRIAL IN THE COMMUNITY

Session Details

Valerie Durkalski
2011 (Vancouver) Annual Meeting

Contributed Session
CHALLENGES IN THE DESIGN AND ANALYSIS OF NON-INFERIORITY TRIALS: A CASE STUDY

Session Details

Robert Rosenheck
2011 (Vancouver) Annual Meeting

Contributed Session
CHALLENGES IN THE DESIGN AND CONDUCT OF CONTROLLED CLINICAL EFFECTIVENESS TRIALS IN SCHIZOPHRENIA

Session Details

Patti Shugarts
2011 (Vancouver) Annual Meeting

Contributed Session
Challenges of Creating and Managing Standards (Common Data Elements) for Use in Clinical Trials

Session Details

Hua Carroll
2011 (Vancouver) Annual Meeting

Contributed Session
CHALLENGES OF REPORTING AND CODING ADVERSE EVENTS IN CLINICAL TRIALS

Session Details

Jochen Dress
2011 (Vancouver) Annual Meeting

Contributed Session
Clinical Trial Auditing in an electronic world: Do not risk you data - validate sufficiently

Session Details

Gabriele Dreier
2011 (Vancouver) Annual Meeting

Contributed Session
Clinical trial registries - where do we stand?

Session Details

Amylou Dueck
2011 (Vancouver) Annual Meeting

Contributed Session
Clinically Significant Effect Sizes for Survival and Response Endpoints using the 1/2 Standard Deviation Rule

Session Details

Fawna Start
2011 (Vancouver) Annual Meeting

Contributed Session
CLOSE OUT GETS THE ATTENTION: BUT WHO TURNS ON THE LIGHTS?

Session Details

Deborah Donnell
2011 (Vancouver) Annual Meeting

Contributed Session
Cluster Randomization of Test and Care Sites in the TLC-Plus Trial

Session Details

Jonathan Cook
2011 (Vancouver) Annual Meeting

Contributed Session
CLUSTERING IN SURGICAL TRIALS: DATABASE OF INTRA-CLUSTER CORRELATIONS

Session Details

Angela Kimel
2011 (Vancouver) Annual Meeting

Contributed Session
Comparison of Adjudicated Events to Initial Clinic Event Reporting in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Trial

Session Details

Qiang Zhang
2011 (Vancouver) Annual Meeting

Contributed Session
Comparison of futility monitoring methods using RTOG clinical trials

Session Details

Evan Hempel
2011 (Vancouver) Annual Meeting

Contributed Session
Complexities of Conducting Substance Abuse Trials

Session Details

Uma Kher
2011 (Vancouver) Annual Meeting

Contributed Session
Conditional Power using an Information Based Approach to Determine Futility in Equivalence Trials

Session Details

Sara Czaja
2011 (Vancouver) Annual Meeting

Contributed Session
Control Groups in Caregiver Intervention Research: Issues and Dilemmas

Session Details

David Kerr
2011 (Vancouver) Annual Meeting

Contributed Session
Creating a Better, Shorter DMC Report: A Stack of Needles, Not a Needle in a Haystack

Session Details

Melissa Leventhal
2011 (Vancouver) Annual Meeting

Contributed Session
CREATING A DIGITAL LIBRARY FOR GYNECOLOGIC ONCOLOGY GROUP (GOG) MANUSCRIPTS UTILIZING THE STATISTICAL AND DATA CENTER (SDC) INFORMATION TECHNOLOGY INFRASTRUCTURE.

Session Details

Brenda Brewer
2011 (Vancouver) Annual Meeting

Contributed Session
CREATING AND SUPPORTING A PRODUCTIVE ENVIRONMENT FOR ANCILLARY STUDY DEVELOPMENT IN A MULTICENTER TRIAL

Session Details

Brenda Brewer
2011 (Vancouver) Annual Meeting

Contributed Session
CREATING AND SUPPORTING A PRODUCTIVE ENVIRONMENT FOR ANCILLARY STUDY DEVELOPMENT IN A MULTICENTER TRIAL

Session Details

Dennis Dixon
2011 (Vancouver) Annual Meeting

Contributed Session
DATA AND SAFETY MONITORING POLICY FOR NIAID CLINICAL TRIALS

Session Details

Letitia Perdue
2011 (Vancouver) Annual Meeting

Contributed Session
Data collection and storage for online screening prior to consent

Session Details

Ariadna Martin
2011 (Vancouver) Annual Meeting

Contributed Session
DESCRIPTION OF THE IMPLEMENTATION AND EXECUTION OF THE SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES STUDY (SPS3) PROMOTED BY THE NIH IN SPAIN.

Session Details

Cathy Yang
2011 (Vancouver) Annual Meeting

Contributed Session
Design and Implementation of a New Query Management System

Session Details

Don (Dongguang) Li
2011 (Vancouver) Annual Meeting

Contributed Session
Determining the optimal biomarker cutoff for defining a subpopulation of cancer patients who may benefit from treatment

Session Details

Johanna Sanchez
2011 (Vancouver) Annual Meeting

Contributed Session
Developing a Final Analysis Timeline for a Large Multicentre Randomised Controlled Trial

Session Details

Amy Donaldson
2011 (Vancouver) Annual Meeting

Contributed Session
Developing statistical standards in an academic data coordinating center

Session Details

Qian Shi
2011 (Vancouver) Annual Meeting

Contributed Session
Development and Implementation of the Hierarchical Bayesian Design in Clinical Trials with Multiple Disease Types

Session Details

Noah Ivers
2011 (Vancouver) Annual Meeting

Contributed Session
Did the extension of CONSORT to cluster randomized trials result in improved quality of reporting and study methodology?

Session Details

Maiken Pontoppidan
2011 (Vancouver) Annual Meeting

Contributed Session
DIFFICULTIES IN RUNNING A RANDOMIZED CONTROLLED TRIAL IN THE REAL WORLD OF SOCIAL INTERVENTIONS IN DENMARK

Session Details

Stephanie Hicks
2011 (Vancouver) Annual Meeting

Contributed Session
Double Data Entry Quality Control in URECA (Urban Environment and Childhood Asthma), a Multisite Longitudinal Study

Session Details

Stephanie Hicks
2011 (Vancouver) Annual Meeting

Contributed Session
Double Data Entry Quality Control in URECA (Urban Environment and Childhood Asthma), a Multisite Longitudinal Study

Session Details

Zhibao Mi
2011 (Vancouver) Annual Meeting

Contributed Session
Duplicate identification using non-sensitive information

Session Details

Mary Larkin
2011 (Vancouver) Annual Meeting

Contributed Session
DYNAMIC EVOLUTION OF THE STUDY COORDINATOR ROLE: THE 25 YEAR EXPERIENCE IN DCCT/EDIC

Session Details

Mary Larkin
2011 (Vancouver) Annual Meeting

Contributed Session
DYNAMIC EVOLUTION OF THE STUDY COORDINATOR ROLE: THE 27 YEAR EXPERIENCE IN DCCT/EDIC

Session Details

Meier Hsu
2011 (Vancouver) Annual Meeting

Contributed Session
Effect of Celecoxib on Adenoma Count in a Randomized Trial of Celecoxib for the Prevention of Sporadic Colorectal Adenoma using a Zero-inflated Poisson (ZIP) Model with Random Effects

Session Details

Karen Boyle
2011 (Vancouver) Annual Meeting

Contributed Session
EFFECTIVE GRAPHICAL DATA DISPLAYS TO FACILITATE EXPEDITED DSMB REVIEW OF CLINICAL TRIAL DATA

Session Details

Yelena Novik
2011 (Vancouver) Annual Meeting

Contributed Session
Efficiency in opening new clinical trials versus efficiency in accruals .

Session Details

Timothy Chang
2011 (Vancouver) Annual Meeting

Contributed Session
Efficient design and analysis of clinical value for paired medical tests at single and serial time points.

Session Details

Sally Bialy
2011 (Vancouver) Annual Meeting

Contributed Session
EFFICIENT MANAGEMENT OF DIVERSIFIED FUNDING WITHIN THE GYNECOLOGIC ONCOLOGY GROUP (GOG) STATISTICAL AND DATA CENTER (SDC)

Session Details

Reza Rostami
2011 (Vancouver) Annual Meeting

Contributed Session
Electronic Health Record and Clinical Trials: Advantages and Data Quality Issues

Session Details

Virginia Howard
2011 (Vancouver) Annual Meeting

Contributed Session
Enrollment and Compliance in a National Physical Activity Study: An Interim Report from the REasons for Geographic and Racial Differences in Stroke (REGARDS) Study

Session Details

Laney Light
2011 (Vancouver) Annual Meeting

Contributed Session
ESTIMATING CLINIC STAFF TIME FOR PATIENT VISITS IN THE ACCORD TRIAL

Session Details

Theodore Karrison
2011 (Vancouver) Annual Meeting

Contributed Session
ESTIMATION OF SURVIVAL FOR ALL TREATED PATIENTS IN THE RANDOMIZED DISCONTINUATION TRIAL DESIGN

Session Details

Guenther Kundt
2011 (Vancouver) Annual Meeting

Contributed Session
Evaluation of Imbalance in Stratified Blocked Randomization by Investigating Validity of Hallstrom & Davies Models

Session Details

Adam Glassman
2011 (Vancouver) Annual Meeting

Contributed Session
Evaluation of Masking Success of Sham Ocular Injections

Session Details

Dirk Lindner
2011 (Vancouver) Annual Meeting

Contributed Session
Evaluation of the diagnostic accuracy of a candidate biomarker to detect dual use of conventional cigarettes in users of non-combusted tobacco products

Session Details

Mae Gordon
2011 (Vancouver) Annual Meeting

Contributed Session
EVENT ADJUDICATION OF VISUAL FIELD ENDPOINTS IN THE OCULAR HYPERTENSION TREATMENT STUDY (OHTS)

Session Details

Clare Jones
2011 (Vancouver) Annual Meeting

Contributed Session
Experiences of delivering a Practice-based Randomized Controlled Trial

Session Details

Carolyn Burke
2011 (Vancouver) Annual Meeting

Contributed Session
Experiences of the NINDS Clinical Research Collaboration with the use of a Virtual Coordinator

Session Details

Kaleab Abebe
2011 (Vancouver) Annual Meeting

Contributed Session
Explaining Treatment-by-Site Interaction in Multisite Clinical Trials: An Application to the TORDIA Clinical Trial

Session Details

Andrew Cook
2011 (Vancouver) Annual Meeting

Contributed Session
Exploring a dataset for proactive identification and overlap checking of planned policy relevant clinical trials

Session Details

Allison Edwards
2011 (Vancouver) Annual Meeting

Contributed Session
Exploring the Potential for Inconclusive Results from a Non-inferiority Trial

Session Details

Andrew M
2011 (Vancouver) Annual Meeting

Contributed Session
Factors Associated with Reporting of Patient Consent in Healthcare Cluster Randomized Trials

Session Details

Dorothee Arenz
2011 (Vancouver) Annual Meeting

Contributed Session
FOSTERING TRANSLATIONAL RESEARCH AT AN ACADEMIC MEDICAL CENTER

Session Details

Barbara Tilley
2011 (Vancouver) Annual Meeting

Contributed Session
Futility Trials in Neurology Revisited

Session Details

Robert Gordon
2011 (Vancouver) Annual Meeting

Contributed Session
Graphics for Visualization of Clinical Trial Safety Data: A Collaboration of the FDA/Industry/Academia Safety Graphic Working Group

Session Details

Kenneth Wu
2011 (Vancouver) Annual Meeting

Contributed Session
Group Sequential Monitoring with the Proportional Odds Model

Session Details

Sarah Brown
2011 (Vancouver) Annual Meeting

Contributed Session
GUIDANCE MANUAL FOR PHASE II TRIAL DESIGN IN CANCER

Session Details

Angela Kuras
2011 (Vancouver) Annual Meeting

Contributed Session
Gynecologic Oncology Group (GOG): Remote Paperless Study Chair Reviews

Session Details

Heike Moenkemann
2011 (Vancouver) Annual Meeting

Contributed Session
Harmonized Standard Operating Procedures for Academic Trials* * Granted by the German Federal Ministry of Research and education, Germany, BMBF 01EZ0931

Session Details

Jochen Dress
2011 (Vancouver) Annual Meeting

Contributed Session
High Quality Risik Management for Clinical Trials: Use the data at your hands to manage risk in your clinical trials

Session Details

Milton Omondi
2011 (Vancouver) Annual Meeting

Contributed Session
HIV Treatment Programs and Clinical Research in East Africa: A Symbiotic Relationship

Session Details

Michelle Mahoney
2011 (Vancouver) Annual Meeting

Contributed Session
How Did We Get Here From There? Experiences from N0147 A North Central Cancer Treatment Group (NCCTG) Phase III Randomized Clinical Trial

Session Details

Yuko Palesch
2011 (Vancouver) Annual Meeting

Contributed Session
HOW DO WE ADAPT THE ANALYSIS PLAN WHEN THE PROTOCOL IS MODIFIED?

Session Details

Erica Anderson
2011 (Vancouver) Annual Meeting

Contributed Session
Implementation of Cardiovascular Cell Therapy Clinical Trials; Points to Consider

Session Details

Colleen Peters
2011 (Vancouver) Annual Meeting

Contributed Session
Implementation of cognitive screening and confidentiality assurance with an on-line survey for measuring population preferences

Session Details

Jennifer Gassman
2011 (Vancouver) Annual Meeting

Contributed Session
Implementing multiple BP measurement methods in an RCT: the Blood Pressure In Hemo Dialysis (BID) Pilot Study

Session Details

Laura Tipton
2011 (Vancouver) Annual Meeting

Contributed Session
Importance of Conference Calls for Coordinators in Multi-Center Clinical Trials

Session Details

Darrin Harris
2011 (Vancouver) Annual Meeting

Contributed Session
IMPROVING CLINICAL TRIAL DATA COLLECTION: A WEB-BASED SYSTEM TO DYNAMICALLY GENERATE STUDY FORMS WITH INTEGRATED BARCODES

Session Details

George Howard
2011 (Vancouver) Annual Meeting

Contributed Session
Imputation of Incident Events in Longitudinal Studies

Session Details

George Howard
2011 (Vancouver) Annual Meeting

Contributed Session
Imputation of survival outcomes in clinical trials to address differential dropout: risk stratified imputation in informative censoring

Session Details

George Howard
2011 (Vancouver) Annual Meeting

Contributed Session
Imputation of survival outcomes in clinical trials: risk-stratified imputation in informative censoring

Session Details

Monica Taljaard
2011 (Vancouver) Annual Meeting

Contributed Session
Inadequate reporting of research ethics review and informed consent in cluster randomized trials: review of a representative sample of published trials

Session Details

Sherita Ala'i
2011 (Vancouver) Annual Meeting

Contributed Session
Incorporating the Curation of Metadata in a Dental Practice-Based Research Network

Session Details

Helen Marshall
2011 (Vancouver) Annual Meeting

Contributed Session
Incorporation of an additional interim analysis during the running of a randomised clinical trial using group sequential design methodology

Session Details

Jaemyung Kim
2011 (Vancouver) Annual Meeting

Contributed Session
INTEGRATION OF SITE PERFORMANCE MONITORING MODULE IN WEB-BASED CTMS FOR A GLOBAL TRIAL

Session Details

Jenny Donovan
2011 (Vancouver) Annual Meeting

Contributed Session
INTERVENTION TO IMPROVE RECRUITMENT TO RANDOMISED CONTROLLED TRIALS

Session Details

Shazia Chaudhry
2011 (Vancouver) Annual Meeting

Contributed Session
Investigator Experiences with the Ethics Review Process of Cluster Randomized Trials: An International Survey

Session Details

Jeff Szychowski
2011 (Vancouver) Annual Meeting

Contributed Session
ISSUES SURROUNDING INTERIM MONITORING OF A 3-ARMED CLINICAL TRIAL: EXPERIENCE FROM A STUDY OF OXYTOCIN REGIMENS FOR PREVENTION OF BLEEDING AFTER VAGINAL DELIVERY

Session Details

Guillermo Ruiz-Palacios
2011 (Vancouver) Annual Meeting

Contributed Session
LA RED: THE FORMATION OF AN EMERGING INFECTIOUS DISEASES CLINICAL RESEARCH NETWORK IN MEXICO

Session Details

Guillaume Martel
2011 (Vancouver) Annual Meeting

Contributed Session
Laparoscopic and open colorectal cancer surgery: an overview of systematic reviews

Session Details

Josephine Measusres
2011 (Vancouver) Annual Meeting

Contributed Session
Lean Sigma in the New Health Landscape: An application in Biostatistics

Session Details

Ben Piper
2011 (Vancouver) Annual Meeting

Contributed Session
Making Meeting Scheduling More Efficient, Simple, and Reliable: Using KAI's Web-based Shared Calendar Application

Session Details

Jody Ciolino
2011 (Vancouver) Annual Meeting

Contributed Session
Measuring continuous baseline covariate imbalances in clinical trial data

Session Details

Aenne Glass
2011 (Vancouver) Annual Meeting

Contributed Session
Meta-Analysis of cardiac surgical trials concerning intramyocardial bone marrow stem cell transplantation

Session Details

Brian Campbell
2011 (Vancouver) Annual Meeting

Contributed Session
Metadata as the Key to Semantic Interoperability in Clinical Data Systems

Session Details

victor zak
2011 (Vancouver) Annual Meeting

Contributed Session
METHODOLOGY AND CHALLENGES IN EXECUTING A PEDIATRIC CARDIOVASCULAR MULTICENTER RANDOMIZED CLINICAL TRIAL FOR OFF-LABEL DRUG USE.

Session Details

Lei Wang
2011 (Vancouver) Annual Meeting

Contributed Session
Methods for choosing a cut point when dichotomizing a continuous response a case study of predicting infant survival with High Resolution Melting score

Session Details

Dalah Mason
2011 (Vancouver) Annual Meeting

Contributed Session
METHODS IN PROMOTING A CLINICAL RESEARCH TRIAL

Session Details

James Dai
2011 (Vancouver) Annual Meeting

Contributed Session
Metrics for evaluating surrogate endpoints with application to HIV prevention trials

Session Details

Catherine Olivier
2011 (Vancouver) Annual Meeting

Contributed Session
MID-RECRUITMENT TRIAL REDESIGN TO INCORPORATE GENETIC SUB-TYPES

Session Details

Donna Levy
2011 (Vancouver) Annual Meeting

Contributed Session
MISSING COVARIATE DATA WITH A SURVIVAL ENDPOINT: PROBLEMS AND SOLUTIONS PERTAINING TO DESIGN, DATA COLLECTION AND ANALYSIS

Session Details

Paul VanVeldhuisen
2011 (Vancouver) Annual Meeting

Contributed Session
Monitoring the Progress of Clinical Trials in a Network Setting: Experience from the National Drug Abuse Treatment Clinical Trials Network

Session Details

Theresa Sax
2011 (Vancouver) Annual Meeting

Contributed Session
Monitoring Therapy Sessions for Adherence to Protocol

Session Details

Suzanne Gillespie
2011 (Vancouver) Annual Meeting

Contributed Session
Multi-site clinical trials protocol and data management training: Overcoming challenges in the age of technological distraction

Session Details

Mary Longbottom
2011 (Vancouver) Annual Meeting

Contributed Session
Multiple Mechanisms to Retain Participants in a Long-Term Randomized Clinical Trial: The Carotid Revascularization Endarterectomy vs. Stenting Trial

Session Details

Deepti Goel
2011 (Vancouver) Annual Meeting

Contributed Session
NEED FOR EXTERNAL AUDITORS IN CLINICAL TRIALS

Session Details

Emine Bayman
2011 (Vancouver) Annual Meeting

Contributed Session
No Large Differences among Centers in a Multi-Center Neurosurgical Clinical Trial

Session Details

Haijing Qin
2011 (Vancouver) Annual Meeting

Contributed Session
Nonparametric Techniques for Method Comparison as Applied to Visual Acuity Scores Obtained with Automated Refraction versus Manual Refraction

Session Details

Suzanne Breeman
2011 (Vancouver) Annual Meeting

Contributed Session
NORMATIVE DATA AND IMPLICATIONS FOR RANDOMISED CONTROLLED TRIALS

Session Details

Milena Radeva
2011 (Vancouver) Annual Meeting

Contributed Session
NOVEL THERAPIES IN RESISTANT FSGS (FONT II) PHASE II CLINICAL TRIAL: STUDY DESIGN AND UPDATE

Session Details

Guillaume Martel
2011 (Vancouver) Annual Meeting

Contributed Session
Oncologic outcomes of laparoscopic and open colorectal cancer surgery: meta-analysis and correlation with expert opinion

Session Details

Marisa De Rosa
2011 (Vancouver) Annual Meeting

Contributed Session
Online/offline ICT platform for Clinical Research in Africa

Session Details

Sue Ross
2011 (Vancouver) Annual Meeting

Contributed Session
Open versus closed access to full academic trial protocols: advantages and disadvantages

Session Details

Geraldine Matthews
2011 (Vancouver) Annual Meeting

Contributed Session
Optimising Trial Monitoring on the AZURE Trial

Session Details

Emily Van Meter
2011 (Vancouver) Annual Meeting

Contributed Session
ordcrm: An R Package for Variations of the Likelihood-Based Continual Reassessment Method Design for Dose Finding Clinical Trials with Ordinal Toxicity Grading

Session Details

Michael Miller
2011 (Vancouver) Annual Meeting

Contributed Session
OUTCOME CHOICE IN THE DESIGN OF CLINICAL TRIALS FOR THE ELDERLY

Session Details

Leah Griffin
2011 (Vancouver) Annual Meeting

Contributed Session
PARTICIPANT DATA ENTRY FOR A WEB BASED DATA MANAGEMENT SYSTEM

Session Details

J Athene Lane
2011 (Vancouver) Annual Meeting

Contributed Session
PEER REVIEW INTERVENTION FOR MONITORING AND EVALUATING SITES THAT IMPROVED RANDOMISED CONTROLLED TRIAL CONDUCT AND PERFORMANCE

Session Details

Roderik Viergever
2011 (Vancouver) Annual Meeting

Contributed Session
Pharmacokinetic research in children: an analysis of registered records of clinical trials

Session Details

Susanne May
2011 (Vancouver) Annual Meeting

Contributed Session
Potential dangers of inappropriate futility boundaries

Session Details

Zhibao Mi
2011 (Vancouver) Annual Meeting

Contributed Session
Power analysis of nominal agreement among multiple raters

Session Details

Simona Barlera
2011 (Vancouver) Annual Meeting

Contributed Session
Predictors of all-causes mortality on 6975 patients of the GISSI-HF trial on heart failure

Session Details

Lindsey Hornung
2011 (Vancouver) Annual Meeting

Contributed Session
PREDICTORS OF BLOOD PRESSURE CONTROL AT 6 AND 12 MONTHS IN THE SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES (SPS3) STUDY

Session Details

Kathryn Mangoff
2011 (Vancouver) Annual Meeting

Contributed Session
PROCESSES IMPLEMENTED TO ENSURE SUCCESSFUL FOLLOW-UP DURING ONGOING RECRUITMENT

Session Details

Robert Edson
2011 (Vancouver) Annual Meeting

Contributed Session
PROGRAM IN R TO CALCULATE ADHERENCE WITH MEDICATION REGIMEN

Session Details

L. Suzanne Firrell
2011 (Vancouver) Annual Meeting

Contributed Session
Project Management - What does it offer Clinical Trials?

Session Details

Tilly Yau
2011 (Vancouver) Annual Meeting

Contributed Session
Project Managers are Worth Their Weight in Gold

Session Details

Jochen Dress
2011 (Vancouver) Annual Meeting

Contributed Session
Quality Risik Management for Clinical Trials Use the data at your hands to manage risk in your clinical trials

Session Details

Thomas Liz
2011 (Vancouver) Annual Meeting

Contributed Session
Quality, quantity and inference: what can we learn from hospitalization endpoints?

Session Details

Patricia Feeney
2011 (Vancouver) Annual Meeting

Contributed Session
RANDOMIZATION AND RANDOM ALLOCATION IN READER DIAGNOSTIC STUDIES

Session Details

Bambi Arnold
2011 (Vancouver) Annual Meeting

Contributed Session
Randomization Issues in a Randomized Multi-center Trial of an Educational Intervention for Improving Glucose Control in Patients with Diabetic Retinopathy

Session Details

Pamela Marcus
2011 (Vancouver) Annual Meeting

Contributed Session
Recruitment methods employed in the National Lung Screening Trial (NLST)

Session Details

Sonya Mergler
2011 (Vancouver) Annual Meeting

Contributed Session
REGIONAL COLLABORATORS' MEETINGS FOR AN INTERNATIONAL STUDY

Session Details

Chengwu Yang
2011 (Vancouver) Annual Meeting

Contributed Session
Regression with latent variables: a better way to analyze composite scores from instruments for subjective outcomes in clinical trials

Session Details

Andrew McRae
2011 (Vancouver) Annual Meeting

Contributed Session
Researchers perceptions of ethical challenges of cluster randomized trials: A qualitative analysis

Session Details

Jochen Dress
2011 (Vancouver) Annual Meeting

Contributed Session
Resolve Problems and Errors - Corrective and Preventive Actions (CAPA) for clinical trials

Session Details

Brett Kaminski
2011 (Vancouver) Annual Meeting

Contributed Session
RESOLVING DISCREPANT SLOPE ESTIMATES FROM SIMPLE LEAST SQUARES VERSUS REPEATED MEASURES REGRESSION

Session Details

Jeannette Lee
2011 (Vancouver) Annual Meeting

Contributed Session
Retention of Clinical Trial Participants in a Study of Non-Gonococcal Urethritis (NGU), a Sexually Transmitted Infection

Session Details

Nicole Close
2011 (Vancouver) Annual Meeting

Contributed Session
Retention Strategies, Methodology and Considerations: An example from a 3.5 year prospective, closed, combined community/workplace clinical epidemiological study in Kenya

Session Details

Brian Hutton
2011 (Vancouver) Annual Meeting

Contributed Session
Risk of death with aprotinin in cardiac surgery: a Bayesian evidence synthesis of randomized and observational studies

Session Details

Kellee Miller
2011 (Vancouver) Annual Meeting

Contributed Session
Risk Ratio verse Odds Ratio in Clinical Trials of Binary Outcomes

Session Details

Jitendra Ganju
2011 (Vancouver) Annual Meeting

Contributed Session
Robust inference via permutation distributions

Session Details

Songfeng Wang
2011 (Vancouver) Annual Meeting

Contributed Session
Sample Size Calculation for PH Cure Model in Survival Trials

Session Details

Pei-Fang Su
2011 (Vancouver) Annual Meeting

Contributed Session
Sample size determination at a fixed time point for correlated right-censored data

Session Details

Xiaomin Lu
2011 (Vancouver) Annual Meeting

Contributed Session
Sequential randomized phase II clinical trial

Session Details

Heemun Kwok
2011 (Vancouver) Annual Meeting

Contributed Session
Simulation study of an indication-finding trial approach to phase II development

Session Details

Clare Jones
2011 (Vancouver) Annual Meeting

Contributed Session
Single-visit scale and polish for gingival health: The results of a primary care RCT

Session Details

Nancy Payte
2011 (Vancouver) Annual Meeting

Contributed Session
Solutions for Monitoring Medical Record Abstraction Quality in a Multi-Center Study

Session Details

Jon Yankey
2011 (Vancouver) Annual Meeting

Contributed Session
Some strategies for report generation by biostatisticians in clinical trials

Session Details

Helen Marshall
2011 (Vancouver) Annual Meeting

Contributed Session
Statistical issues in the design of randomised surgical trials: a practical example of the possible solutions

Session Details

Mariam Saleem
2011 (Vancouver) Annual Meeting

Contributed Session
STRATEGIES IMPLEMENTED TO ACHIEVE THE FOLLOW-UP GOAL IN A 5-YEAR FOLLOW-UP STUDY

Session Details

Katherine Trigiani
2011 (Vancouver) Annual Meeting

Contributed Session
STRATEGIES TO MAXIMIZE ENROLMENT FOR TRIALS REQUIRING IN-HOSPITAL POSTPARTUM/POSTNATAL RECRUITMENT

Session Details

Robert Lindblad
2011 (Vancouver) Annual Meeting

Contributed Session
Suicide Risk in Substance Abuse Treatment Clinical Trials, Is Adverse Event Reporting Alone Sufficient?

Session Details

Brent Shelton
2011 (Vancouver) Annual Meeting

Contributed Session
Supplementing the OnCore Clinical Research Management System with a Web-Based Blinded Randomization Module for Investigator Initiated Oncology Trials

Session Details

Roxanne Ward
2011 (Vancouver) Annual Meeting

Contributed Session
Systematic Review of the Methods and Effects of Source Data Verification in Clinical Research

Session Details

Aditi Sapre
2011 (Vancouver) Annual Meeting

Contributed Session
Testing lipid treatment effects in the presence of skewed data caused by off-therapy discontinuation values

Session Details

Traci Schwieger
2011 (Vancouver) Annual Meeting

Contributed Session
The Benefits and Challenges of Utilizing a European CRO to Facilitate Master File Maintenance, Health Authority Submissions, and On-Site Monitoring for an International Clinical Trial

Session Details

Lawrence Mbuagbaw
2011 (Vancouver) Annual Meeting

Contributed Session
The Cameroon Mobile Phone SMS (CAMPS) Trial: the Protocol for a Randomized Controlled Trial of Mobile phone text messaging versus usual care for improving adherence to HAART

Session Details

Scott Gould
2011 (Vancouver) Annual Meeting

Contributed Session
THE CHALLENGES OF FACILITATING AND SUPPORTING THE EFFICIENT AND SECURE EXCHANGE OF DATA IN A MULTI-SITE COOPERATIVE GROUP THAT IS FUNDED BY GOVERNMENT AND INDUSTRY

Session Details

Letitia Perdue
2011 (Vancouver) Annual Meeting

Contributed Session
The Challenges of Recruiting for an Ancillary Study Initiated after an Ongoing Clinical Trial

Session Details

Jennifer Menzies
2011 (Vancouver) Annual Meeting

Contributed Session
THE CONTROL OF HYPERTENSION IN PREGNANCY STUDY (CHIPS) REGIONAL COLLABORATORS' TELECONFERENCES - AN EFFECTIVE APPROACH TO REGIONAL CO-ORDINATION

Session Details

CHAO-YIN CHEN
2011 (Vancouver) Annual Meeting

Contributed Session
The delicate balance between independence and collaboration: Perspectives from academic and industry statisticians

Session Details

Xiaoming Li
2011 (Vancouver) Annual Meeting

Contributed Session
The Durability of Vaccine Efficacy on the Incidence of Herpes Zoster Afforded by ZOSTAVAX

Session Details

Keiko Sing
2011 (Vancouver) Annual Meeting

Contributed Session
THE EFFECT OF SHORT MESSAGING SERVICE (SMS) USE FOR SUBJECT COMPLIANCE IN CLINICAL TRIALS

Session Details

Danielle Johnson
2011 (Vancouver) Annual Meeting

Contributed Session
THE IMPACT OF SUBSTANTIAL CASE REPORT FORM MODIFICATIONS POST DATABASE LAUNCH IN A MULTI-CENTER DATA REGISTRY

Session Details

Lucy Turner
2011 (Vancouver) Annual Meeting

Contributed Session
The Influence on CONSORT on the quality of RCTs: An updated review

Session Details

Joerg Hasford
2011 (Vancouver) Annual Meeting

Contributed Session
The Lack of Representativeness of Patients in Randomized Trials endanger the Scientific Basis of Evidence-based Medicine

Session Details

W. Jack Rejeski
2011 (Vancouver) Annual Meeting

Contributed Session
The Lifestyle Interventions and Independence for Elders (LIFE) Intervention Tracking System: Monitoring Treatment Fidelity and Promoting Behavior Change

Session Details

Anne Lindblad
2011 (Vancouver) Annual Meeting

Contributed Session
The National Institute of Neurological Disorders and Stroke Clinical Research Collaboration (NINDS CRC); Summary of Pilot Activities.

Session Details

Christopher Coffey
2011 (Vancouver) Annual Meeting

Contributed Session
The Parkinson's Progression Markers Initiative: A Prospective Biomarkers Study

Session Details

Wai Yin Yeung
2011 (Vancouver) Annual Meeting

Contributed Session
The power of the biased coin design for clinical trials

Session Details

David Lau
2011 (Vancouver) Annual Meeting

Contributed Session
The process of developing an online randomisation system

Session Details

Roderik Viergever
2011 (Vancouver) Annual Meeting

Contributed Session
The quality of registration of clinical trials

Session Details

Ana Roldan
2011 (Vancouver) Annual Meeting

Contributed Session
The Secondary Prevention of Small Subcortical Strokes study experience at international sites

Session Details

Fiona Collinson
2011 (Vancouver) Annual Meeting

Contributed Session
The STAR trial: Can Quality of Life benefit offset any survival detriment?

Session Details

Hsien Seow
2011 (Vancouver) Annual Meeting

Contributed Session
The sustainability of funding academic oncology clinical trials: A ponzi scheme

Session Details

Toshinori Murayama
2011 (Vancouver) Annual Meeting

Contributed Session
The unique system for 'Unnotified Clinical Trials to the Authority' in JAPAN

Session Details

Kit Howard
2011 (Vancouver) Annual Meeting

Contributed Session
The World of Standards: An Overview of Current Standards and How They Can Help You

Session Details

Neal Oden
2011 (Vancouver) Annual Meeting

Contributed Session
Theoretical error rates of qualitative UDS tests for stimulants

Session Details

Janice Pogue
2011 (Vancouver) Annual Meeting

Contributed Session
Time to composite outcomes with semi-competing risk: A comparison of methods to detect treatment heterogeneity within a composite outcome

Session Details

Michael Mi
2011 (Vancouver) Annual Meeting

Contributed Session
title

Session Details

Sharon Wilmoth
2011 (Vancouver) Annual Meeting

Contributed Session
TRANSFERRING RANDOMIZED PARTICIPANTS - THE ACCORD MODEL

Session Details

MARION CAMPBELL
2011 (Vancouver) Annual Meeting

Contributed Session
TRIALS IN SURGERY: EVALUATING A SIMPLE OR A COMPLEX INTERVENTION?

Session Details

Heather Litman
2011 (Vancouver) Annual Meeting

Contributed Session
Twenty four Month Outcomes of Randomized Equivalence Trial of Two Surgical Techniques for Women with Stress Urinary Incontinence: Retropubic and Transobturator Midurethral Slings (TOMUS)

Session Details

Marlene Leung
2011 (Vancouver) Annual Meeting

Contributed Session
UNMASKING PATIENTS WHILE MINIMIZING BIAS IN FUTURE FOLLOW-UP STUDIES

Session Details

Michael Shi
2011 (Vancouver) Annual Meeting

Contributed Session
Using Open Source Electronic Data Capture for large randomised controlled trials

Session Details

Melissa Jovellanos
2011 (Vancouver) Annual Meeting

Contributed Session
USING STANDARDIZED PATIENTS TO HELP ASSESS AN APPLICANT'S THERAPEUTIC POTENTIAL IN A PSYCHOTHERAPY TREATMENT TRIAL

Session Details

Lynn Huynh
2011 (Vancouver) Annual Meeting

Contributed Session
Using the Heckman Model to Impute Indirect Financial Burden for the Surgical Treatments Outcomes Project for Dysfunctional Uterine Bleeding (STOP-DUB) Trial

Session Details

Fei Wang
2011 (Vancouver) Annual Meeting

Contributed Session
Validating Data Merging in Longitudinal Studies and Joint Modeling of Merged Longitudinal Data

Session Details

Brandy Lind
2011 (Vancouver) Annual Meeting

Contributed Session
Website Designed To Facilitate Data And Safety Monitoring Board Reviews

Session Details

Kit Howard
2011 (Vancouver) Annual Meeting

Contributed Session
What is Data Quality in Clinical Trials?

Session Details

Heidi Christ-Schmidt
2011 (Vancouver) Annual Meeting

Contributed Session
What is baseline and change? An example from studies of eGFR.

Session Details

Yuko Palesch
2011 (Vancouver) Annual Meeting

Contributed Session
WHEN SHOULD RCTS STANDARDIZE CO-INTERVENTIONS?

Session Details

Colin Begg
2010 (Baltimore) Annual Meeting

Presidential Welcome

José Pinheiro
2010 (Baltimore) Annual Meeting

Special Presentation
Workshop: Adaptive Clinical Trials (2) Adaptive Dose-Ranging Designs and Methods

Roger Lewis
2010 (Baltimore) Annual Meeting

Special Presentation
Workshop: Adaptive Clinical Trials (1) Short Course

Jason Connor
2010 (Baltimore) Annual Meeting

Special Presentation
Workshop: Adaptive Clinical Trials (3) Bayesian Adaptive Designs for Clinical Trials

Joshua Sharfstein
2010 (Baltimore) Annual Meeting

Curtis Meinert Lecture
FDA, Clinical Trials, and Public Health

Richard Schilsky
2010 (Baltimore) Annual Meeting

Founders Lecture
Publicly Funded Clinical Trials in the Era of Comparative Research Effectiveness

2010 (Baltimore) Annual Meeting

Fellows Presentation
Presentation of the Class of 2010 Fellows

Marco Ghidina
2010 (Baltimore) Annual Meeting

Contributed Session
"Large simple studies": flexible data entry solutions to minimize data entry and reporting errors

Session Details

Scott O'Neal
2010 (Baltimore) Annual Meeting

Contributed Session
...OF OUR ELABORATE PLANS: COORDINATING THE END OF A LARGE CLINICAL TRIAL

Session Details

Ying "Denise" Wang
2010 (Baltimore) Annual Meeting

Contributed Session
A BOOTSTRAP APPROACH IN ESTIMATING SURVIVAL PROBABILITY FOR A PHASE III PEDIATRIC ONCOLOGY CLINICAL TRIAL WITH A DELAYED RANDOMIZATION SCHEDULE

Session Details

Alice Pressman
2010 (Baltimore) Annual Meeting

Contributed Session
A comparison of two worlds: how does Bayes hold up to the status quo for the analysis of clinical trials?

Session Details

Briggs Morrison
2010 (Baltimore) Annual Meeting

Contributed Session
A CTTI SURVEY OF CURRENT MONITORING PRACTICES

Session Details

Lynette Keyes-Elstein
2010 (Baltimore) Annual Meeting

Contributed Session
A New Global Composite Score for Scleroderma Reduces the Sample Size to Complete the Scleroderma Cyclophosphamide or Transplantation (SCOT) Study

Session Details

Christine Wolf
2010 (Baltimore) Annual Meeting

Contributed Session
A Novel Method of Identifying and Studying Children Using Psychotropic Medications

Session Details

Adin-Cristian Andrei
2010 (Baltimore) Annual Meeting

Contributed Session
A novel recurrent events modeling framework based on pseudo-values

Session Details

SEUNGBONG HAN
2010 (Baltimore) Annual Meeting

Contributed Session
A novel semiparametric method for modeling interval-censored data

Session Details

Cathy Yang
2010 (Baltimore) Annual Meeting

Contributed Session
A Paperless and Automated Approach of Publishing e-Newsletters for Several Multicentre Randomized Control Trials

Session Details

Kellee Miller
2010 (Baltimore) Annual Meeting

Contributed Session
A PROPOSED METHOD OF LOGARITHMIC TRANSFORMATION OF MACULAR THICKNESS DATA IN CLINICAL RESEARCH

Session Details

Marian Lake
2010 (Baltimore) Annual Meeting

Contributed Session
A QUALITY ASSURANCE MODEL AT A SINGLE MULTI-SITE CLINICAL RESEARCH UNIT

Session Details

Ronald Zimmerman
2010 (Baltimore) Annual Meeting

Contributed Session
A QUESTIONNAIRE TO MEASURE SATISFACTION OF CLINICAL TRIAL PARTICIPANTS: THE ACRN EXPERIENCE

Session Details

George Whitmore
2010 (Baltimore) Annual Meeting

Contributed Session
A THRESHOLD REGRESSION MODEL FOR RECURRENT EXACERBATIONS IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE

Session Details

Toshinori Murayama
2010 (Baltimore) Annual Meeting

Contributed Session
A total amendment of Ethical Guidelines for Clinical Studies in Japan

Session Details

Neha Mehta
2010 (Baltimore) Annual Meeting

Contributed Session
A Unique Environmental Translational Research Opportunity

Session Details

TAO WANG
2010 (Baltimore) Annual Meeting

Contributed Session
A WEB-BASED RANDOMIZATION APPLICATION

Session Details

Jill Kuennen
2010 (Baltimore) Annual Meeting

Contributed Session
A WEB-BASED SOLUTION TO THE DISTRIBUTION OF CONFIDENTIAL INVESTIGATOR BROCHURES

Session Details

John Kairalla
2010 (Baltimore) Annual Meeting

Contributed Session
ACHIEVING THE BENEFITS OF BOTH AN INTERNAL PILOT AND INTERIM ANALYSIS IN LARGE AND SMALL SAMPLES

Session Details

Ying Zhang
2010 (Baltimore) Annual Meeting

Contributed Session
An Adaptive Futility Monitoring Method with Time-Varying Conditional Power Boundary

Session Details

Adam Glassman
2010 (Baltimore) Annual Meeting

Contributed Session
An Electronic Method to Address Challenges of Financial Disclosures in a Multi-Center Clinical Trials Network

Session Details

Zhengjia Chen
2010 (Baltimore) Annual Meeting

Contributed Session
An Extended Escalation with Overdose Control (EWOC) Design Treats Toxicity Response as a Quasi-continuous Variable

Session Details

Bin Huang
2010 (Baltimore) Annual Meeting

Contributed Session
APPLICATION OF RECENT BAYESIAN INTERIM MONITORING STRATEGIES IN PHASE II SCREENING TRIALS IN BREAST CANCER

Session Details

Mariana Carballo
2010 (Baltimore) Annual Meeting

Contributed Session
APPLICATION OF SIMPLE STATISTICAL METHODS TO EVALUATED POSSIBLE DATA FABRICATION: AN EXAMPLE USING THE ACT TRIAL.

Session Details

Joe Lengfellner
2010 (Baltimore) Annual Meeting

Contributed Session
Applying a Web-Based Approach to Database Project Management

Session Details

Cynthia Diltz
2010 (Baltimore) Annual Meeting

Contributed Session
AUTOMATIC NOTIFICATIONS FOR ONLINE ADVERSE EVENT REPORTING

Session Details

Wenle Zhao
2010 (Baltimore) Annual Meeting

Contributed Session
Balancing Continuous and Ordinal Covariates in Clinical Trial Randomization

Session Details

Shamaila Anwar
2010 (Baltimore) Annual Meeting

Contributed Session
BARRIERS TO THE IMPLEMENTATION OF CLUSTER STROKE REHABILITATION TRIALS

Session Details

Karen Boyle
2010 (Baltimore) Annual Meeting

Contributed Session
BIOSTATISTICAL CHALLENGES AND SUCCESSES IN THE TRANSITION OF A LARGE-SCALE COORDINATING CENTER: A CASE STUDY

Session Details

Dorothee Arenz
2010 (Baltimore) Annual Meeting

Contributed Session
BUDGETING STAFF COSTS AT THE STUDY SITE IN ADVANCE OF A CLINICAL TRIAL

Session Details

Caroline Free
2010 (Baltimore) Annual Meeting

Contributed Session
Can the application of a marketing model help imporve recruitment to clinical trials: Txt2stop a case study

Session Details

Catherine Dillon
2010 (Baltimore) Annual Meeting

Contributed Session
Case Report Form Design for Web-based Clinical Trial Data Management

Session Details

Heather Kopetskie
2010 (Baltimore) Annual Meeting

Contributed Session
CASE STUDY: LESSONS LEARNED FROM THE TRANSITION OF A LARGE-SCALE NIH COORDINATING CENTER

Session Details

Gideon Bahn
2010 (Baltimore) Annual Meeting

Contributed Session
CAUSAL EFFECT MODEL USING MATCHING METHODS FROM BOTH FISHER'S EXPERIMENTAL DESIGN AND RUBIN'S CAUSAL MODEL

Session Details

Ozlem Topaloglu
2010 (Baltimore) Annual Meeting

Contributed Session
CHARACTERISTICS AND QUALITY OF REPORTING IN PUBLISHED PHASE II PROSTATE CANCER TRIALS

Session Details

Michael Terrin
2010 (Baltimore) Annual Meeting

Contributed Session
CLINICAL SITE VARIABILITY IN ADHERENCE AND INTERMEDIATE OUTCOMES

Session Details

Junting Zheng
2010 (Baltimore) Annual Meeting

Contributed Session
Clinical Trial Office Workload Assessment through Annual Survey

Session Details

Jörg Vehreschild
2010 (Baltimore) Annual Meeting

Contributed Session
ClinicalSurveys.net A Web-based Research Portal for Rare Diseases

Session Details

Trinh Hoac
2010 (Baltimore) Annual Meeting

Contributed Session
Co-ordinating the Control of Hypertension In Pregnancy Study (CHIPS) with Various Research Ethics Board Approaches

Session Details

Lillian Mutengu
2010 (Baltimore) Annual Meeting

Contributed Session
COMMUNITY ENGAGEMENT: INNOVATIONS IN HIV PREVENTION RESEARCH

Session Details

Hester Lingsma
2010 (Baltimore) Annual Meeting

Contributed Session
COVARIATE ADJUSTEMENT AND ORDINAL OUTCOME ANALYSIS INCREASE POWER IN TRAUMATIC BRAIN INJURY TRIALS

Session Details

Timothy Ramsay
2010 (Baltimore) Annual Meeting

Contributed Session
Covariate adjustment in logistic regression

Session Details

Ann Sieber
2010 (Baltimore) Annual Meeting

Contributed Session
Critical Strategies for Management of PI Non-Compliance: Minimizing Surprises to Ensure Timely Corrective Action Following QA/QI Audit

Session Details

Elaine Murphy
2010 (Baltimore) Annual Meeting

Contributed Session
CROSS-FUNCTIONAL TEAM APPROACH TO STANDARDIZING BUDGETING AND FUNDING PROCESSES FOR MULTI-SITE CLINICAL TRIALS WITHIN A FEDERAL PROGRAM

Session Details

Cynthia Stockdale
2010 (Baltimore) Annual Meeting

Contributed Session
Cynthia Stockdale

Session Details

Tibor Szentendrei
2010 (Baltimore) Annual Meeting

Contributed Session
DATA AND SAFETY MONITORING BOARD LIABILITY INSURANCE FOR THE NATIONAL INSTITUTES OF HEALTH, NIH

Session Details

Hrishikesh Chakraborty
2010 (Baltimore) Annual Meeting

Contributed Session
Data Coordinating Center Challenges and Implemented Solutions for the Oral Cleft Prevention Program in Brazil

Session Details

Monica Nelsen
2010 (Baltimore) Annual Meeting

Contributed Session
DESIGN AND METHODS OF A STROKE CLINICAL TRIAL: ICARE

Session Details

Amanda Farrin
2010 (Baltimore) Annual Meeting

Contributed Session
DESIGN CHALLENGES FOR CLUSTER RANDOMISED TRIALS IN STROKE REHABILITATION

Session Details

Dongyun Yang
2010 (Baltimore) Annual Meeting

Contributed Session
DESIGN OF RANDOMIZED PHASE II TRIALS WITH A TIME TO EVENT PRIMARY ENDPOINT AND AN INTERIM FUTILITY ANALYSIS

Session Details

Lee Warner
2010 (Baltimore) Annual Meeting

Contributed Session
DESIGNING A CONTROLLED TRIAL TO ASSESS INTERVENTION EFFECTIVENESS IN A SEXUALLY TRANSMITTED DISEASE CLINIC PATIENT POPULATION: THE SAFE IN THE CITY STUDY

Session Details

Michelle Collinson
2010 (Baltimore) Annual Meeting

Contributed Session
DESIGNING AND ANALYSING CLINICAL TRIALS OF BEHAVIOURAL INTERVENTIONS IN MENTAL HEALTH: CHALLENGES AND SOLUTIONS

Session Details

Lynn Huynh
2010 (Baltimore) Annual Meeting

Contributed Session
Designing efficient clinical trials using discrete event simulation

Session Details

Allison Northen
2010 (Baltimore) Annual Meeting

Contributed Session
DETERMINANTS OF COMPLIANCE IN A RANDOMIZED TRIAL IN HIGH RISK PREGNANCY

Session Details

Allison Northen
2010 (Baltimore) Annual Meeting

Contributed Session
DETERMINANTS OF COMPLIANCE IN A RANDOMIZED TRIAL IN PREGNANCY

Session Details

Jennifer Burr
2010 (Baltimore) Annual Meeting

Contributed Session
DEVELOPING A POPULATION LEVEL COMPLEX INTERVENTION: GLAUCOMA SCREENING ON TRIAL

Session Details

Jennifer Burr
2010 (Baltimore) Annual Meeting

Contributed Session
DEVELOPING A POPULATION LEVEL COMPLEX INTERVENTION: GLAUCOMA SCREENING ON TRIAL

Session Details

J. Johanna Sanchez
2010 (Baltimore) Annual Meeting

Contributed Session
Developing a Standardized Set of Standard Operating Procedures at a Multi-trial Data Coordinating Centre

Session Details

Jenny Donovan
2010 (Baltimore) Annual Meeting

Contributed Session
DEVELOPMENT AND APPLICATION OF A COMPLEX INTERVENTION TO IMPROVE RECRUITMENT TO RANDOMISED CONTROLLED TRIALS

Session Details

Jay Johnson
2010 (Baltimore) Annual Meeting

Contributed Session
Devising Measurements for Remediation Plans

Session Details

Robert Annechiarico
2010 (Baltimore) Annual Meeting

Contributed Session
Distilling Knowledge from Information: The Genesis of the caBIG® CTMS Knowledge Center

Session Details

Dorothee Arenz
2010 (Baltimore) Annual Meeting

Contributed Session
DOCUMENTATION OF PATIENT DATA IN ORIGINAL DOCUMENTS AND CASE REPORT FORMS. A STANDARD OPERATING PROCEDURE.

Session Details

Laney Light
2010 (Baltimore) Annual Meeting

Contributed Session
Double Data Entry in the ACCORD Trial

Session Details

Megan Parks
2010 (Baltimore) Annual Meeting

Contributed Session
E-PROJECT: A WEB-BASED SYSTEM TO ENHANCE THE PURE MATRIX OF PROJECT MANAGEMENT FOR BIOSTATISTICAL INFORMATICS

Session Details

ESTEVE-ALLEMAND LAURE
2010 (Baltimore) Annual Meeting

Contributed Session
EARLY REMOTE CHECK OF THE EXISTENCE AND THE COMPLIANCE WITH REGULATORY REQUIREMENTS OF SIGNED INFORMED CONSENT IN A FRENCH ACADEMIC CLINICAL TRIAL UNIT (CTU)

Session Details

April Slee
2010 (Baltimore) Annual Meeting

Contributed Session
EFFECT OF ADJUDICATION ON CAUSE OF DEATH IN THE AFFIRM TRIAL: EVIDENCE FOR BIAS BY UNBLINDED LOCAL INVESTIGATORS

Session Details

Julie Qidwai
2010 (Baltimore) Annual Meeting

Contributed Session
Electronic Data Entry and Calculation of HYPO Scores in a Multi-Center Clinical Trial of Islet Transplantation for Type 1 Diabetes

Session Details

Alessandra Akiko Kodama
2010 (Baltimore) Annual Meeting

Contributed Session
Electronic web system for randomization, data capture and management: accessible technology for conducting multicenter clinical trials

Session Details

Jonathan Cook
2010 (Baltimore) Annual Meeting

Contributed Session
Eliciting expertise and belief about surgical learning - a case study within the UKUFF surgical trial

Session Details

Kit Howard
2010 (Baltimore) Annual Meeting

Contributed Session
Enabling Efficient Electronic Regulatory Submissions for Medical Devices Using CDISC Data Standards

Session Details

Susan Janiszewski
2010 (Baltimore) Annual Meeting

Contributed Session
Ending a Clinical Trial with Clean Data Its Achievable

Session Details

Richard Holubkov
2010 (Baltimore) Annual Meeting

Contributed Session
ENDPOINT SELECTION IN THE NHLBI THERAPEUTIC HYPOTHERMIA AFTER CARDIAC ARREST (THAPCA) TRIALS

Session Details

Ann Sieber
2010 (Baltimore) Annual Meeting

Contributed Session
Enhancing QA/QI Audit Effectiveness: Development and Implementation of a Web-based Human Research Compliance Database

Session Details

David Shaw
2010 (Baltimore) Annual Meeting

Contributed Session
ETHICOVIGILANCE IN CLINICAL TRIALS

Session Details

Don (Dongguang) Li
2010 (Baltimore) Annual Meeting

Contributed Session
Evaluate treatment effect in Phase I trial - a mission possible?

Session Details

Mae Gordon
2010 (Baltimore) Annual Meeting

Contributed Session
EVENT ADJUDICATION INCREASES ESTIMATE OF TREATMENT EFFECT IN THE OCULAR HYPERTENSION TREATMENT STUDY (OHTS)

Session Details

Chris Barker
2010 (Baltimore) Annual Meeting

Contributed Session
Exploratory Graphical Summaries of Longitudinal Concomitant Medication data

Session Details

J Athene Lane
2010 (Baltimore) Annual Meeting

Contributed Session
Factors influencing questionnaire response rates in trials

Session Details

Brett Goldenberg
2010 (Baltimore) Annual Meeting

Contributed Session
Factors Relating to Superior Outcomes in Sober-Living Facilities

Session Details

Brett Goldenberg
2010 (Baltimore) Annual Meeting

Contributed Session
Factors Relating to Superior Outcomes in Sober-Living Facility

Session Details

Caroline Free
2010 (Baltimore) Annual Meeting

Contributed Session
Four controlled trials of interventions to increase recruitment to the Txt2stop trial

Session Details

Angela Kuras
2010 (Baltimore) Annual Meeting

Contributed Session
Gynecologic Oncology Group (GOG): Quality Control of Electronically Captured Data

Session Details

Michael Larsen
2010 (Baltimore) Annual Meeting

Contributed Session
High Dimension Multiple Imputation: Missing Blood Glucose Values in the Epidemiology of Diabetes Interventions and Complications Study

Session Details

Julia Wade
2010 (Baltimore) Annual Meeting

Contributed Session
How informed is your consent? Techniques to facilitate informed consent in trial recruitment

Session Details

PASCALE RONDEAU
2010 (Baltimore) Annual Meeting

Contributed Session
HOW TO MANAGE THE INTERACTION PRODUCT BY PERIOD IN A CROSS OVER DESIGN APPLIED IN A CLINICAL STUDY IN NUTRITION

Session Details

Elise Cook
2010 (Baltimore) Annual Meeting

Contributed Session
Impact of Supplemental Site Grants to Increase African American Accrual for the Selenium and Vitamin E Cancer Prevention Trial

Session Details

T. Howard Stone
2010 (Baltimore) Annual Meeting

Contributed Session
IMPLEMENTATION AND OUTCOMES OF A RESEARCH ETHICS EDUCATION PROGRAM FOR CLINICAL INVESTIGATORS

Session Details

Sonya Serra
2010 (Baltimore) Annual Meeting

Contributed Session
IMPLEMENTING SAFETY MONITORING COMMITTEES FOR THE NATIONAL INSTITUTES OF HEALTH (NIH)

Session Details

Shann Williams
2010 (Baltimore) Annual Meeting

Contributed Session
Improved Clinical Trial Management with an Electronic Visit Control Sheet

Session Details

Bogdan Ene-Iordache
2010 (Baltimore) Annual Meeting

Contributed Session
Integrating Open Source software for Data Collection and Management in Outcomes Research: the Remission Clinic Network

Session Details

Suzanne Breeman
2010 (Baltimore) Annual Meeting

Contributed Session
INTENSIVE CARE RANDOMISED CONTROLLED TRIALS: ISSUES ASSOCIATED WITH PARTICIPANT RETENTION

Session Details

Steven Berkey
2010 (Baltimore) Annual Meeting

Contributed Session
INTERACTIVE TELEPHONE SYSTEM FOR FACILITATING AUTOMATION OF CLINICAL TRIALS (ITS FACT)

Session Details

KyungMann Kim
2010 (Baltimore) Annual Meeting

Contributed Session
Interim Reports for Data Monitoring Committee vs Clinical Study Reports for Regulatory Authorities

Session Details

Zhigang Zhang
2010 (Baltimore) Annual Meeting

Contributed Session
Interval censored clinical data: how to report and analyze them

Session Details

Kristine Nelson
2010 (Baltimore) Annual Meeting

Contributed Session
LESSONS LEARNED AND CHALLENGES OF DATA ACQUISITION FROM MEDICAL DEVICES FOR PRIMARY OUTCOMES OF A CLINICAL TRIAL

Session Details

Matthias Hassenpflug
2010 (Baltimore) Annual Meeting

Contributed Session
LESSONS LEARNT IN SURGICAL TRIALS 5 YEARS OF EXPERIENCE IN THE STUDY CENTRE OF THE GERMAN SURGICAL SOCIETY: (2004-2009)

Session Details

Allan Hackshaw
2010 (Baltimore) Annual Meeting

Contributed Session
LONG-TERM FOLLOW UP OF CLINICAL TRIALS: IS IT WORTH IT?

Session Details

Patricia Cleary
2010 (Baltimore) Annual Meeting

Contributed Session
Long-Term Quality Control in the Epidemiology of Diabetes Interventions and Complications (EDIC) Study

Session Details

Trinh Hoac
2010 (Baltimore) Annual Meeting

Contributed Session
Managing Differing Research Ethics Board Processes in International Trials

Session Details

bouyssou caroline
2010 (Baltimore) Annual Meeting

Contributed Session
Measure of customer satisfaction in academic clinical research: the case of the CMG-EC (Clinical trials Unit) / ANRS (French National Agency for Research on AIDS and Viral Hepatitis)

Session Details

Frank Molnar
2010 (Baltimore) Annual Meeting

Contributed Session
Measures of Clinical Significance employed in Dementia Drug RCTs.

Session Details

Heather Sampson
2010 (Baltimore) Annual Meeting

Contributed Session
Meeting Ethical Standards for Clinical Research: The Toronto East General Hospital Experience

Session Details

Katrin Jensen
2010 (Baltimore) Annual Meeting

Contributed Session
META-ANALYSIS OF TWO-FACTOR INTERVENTIONS: AN EXAMPLE FROM SURGERY

Session Details

Rongmei Zhang
2010 (Baltimore) Annual Meeting

Contributed Session
Mixed type of responses in dose-finding experiments

Session Details

Yelena Novik
2010 (Baltimore) Annual Meeting

Contributed Session
Monitoring data and compliance in institutional cancer trials: consistent quality inprovement by internal peer audit process.

Session Details

Marlene Leung
2010 (Baltimore) Annual Meeting

Contributed Session
MONITORING DISCREPANCIES BETWEEN PRIMARY AND FOLLOW-UP DATABASES

Session Details

Elizabeth Avery
2010 (Baltimore) Annual Meeting

Contributed Session
MONITORING INTERVENTION FIDELITY OF INDIVIDUALIZED BEHAVIORAL INTERVENTIONS

Session Details

Delilah Cook
2010 (Baltimore) Annual Meeting

Contributed Session
MONITORING PUBLICATIONS AND PRESENTATIONS SUBMISSIONS FOR A MULTI-CENTER CLINICAL TRIAL

Session Details

Brenda Kurland
2010 (Baltimore) Annual Meeting

Contributed Session
Multi-center trials using FDG PET to predict chemotherapy response: Effects of differential measurement error and bias on study power

Session Details

Gillian Worthy
2010 (Baltimore) Annual Meeting

Contributed Session
Multi-state models for analysing cardiovascular events

Session Details

Ming Yin
2010 (Baltimore) Annual Meeting

Contributed Session
Multiplicity adjustments for trials with co-primary endpoints and multiple doses

Session Details

Joni Beshansky
2010 (Baltimore) Annual Meeting

Contributed Session
National Implementation of Exception from Informed Consent Requirements for Emergency Research (21CFR50.24) Process and 1-Year Experience in the IMMEDIATE Trial

Session Details

Kristy Miller
2010 (Baltimore) Annual Meeting

Contributed Session
NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE (NINDS), NATIONAL INSTITUTES OF HEALTH (NIH), COMMON DATA ELEMENT (CDE) PROJECT: DEVELOPING DISEASE-SPECIFIC CDES

Session Details

Curtis Meinert
2010 (Baltimore) Annual Meeting

Contributed Session
Nineteen Year History of Training Clinical Trialists

Session Details

Franca Barton
2010 (Baltimore) Annual Meeting

Contributed Session
NON-RANDOMIZED, SINGLE-ARM TRIALS AS A COMPLEMENTARY METHODOLOGY TO RCTs IN ISLET TRANSPLANTATION

Session Details

Adeniyi Adewale
2010 (Baltimore) Annual Meeting

Contributed Session
On the Use of Expanded Confidence Intervals for Equivalence Hypotheses

Session Details

Jennifer Cockroft
2010 (Baltimore) Annual Meeting

Contributed Session
OPERATIVE EXPERIENCE FROM THE DEPARTMENT OF VETERANS AFFAIRS DNA BANK FOR CLINICAL TRIALS

Session Details

Ying Lu
2010 (Baltimore) Annual Meeting

Contributed Session
Optimal Time-to-Decision Design for Phase II Two-stage Cancer Clinical Trials

Session Details

Linda Ferrari
2010 (Baltimore) Annual Meeting

Contributed Session
OVERREADING APPLICATION OF PULMONARY FUNCTION TESTING FORMS (PFT) IN THE CHILDHOOD ASTHMA RESEARCH AND EDUCATION (CARE) NETWORK

Session Details

Yun Lu
2010 (Baltimore) Annual Meeting

Contributed Session
PEDIATRIC PHARMACOLOGY RESEARCH UNIT (PPRU) TOOLBOX: STANDARD CRF LIBRARY AIDES STUDY START-UP AND MORE

Session Details

Jody Ciolino
2010 (Baltimore) Annual Meeting

Contributed Session
Perfect Baseline Covariate Balances in Clinical Trials and Implications on Power

Session Details

Harold Lehmann
2010 (Baltimore) Annual Meeting

Contributed Session
Physicians' Bayesian Behavior Via Online Bayesian Communication

Session Details

Stan Shapiro
2010 (Baltimore) Annual Meeting

Contributed Session
Placebos: Much Ado About Nothing

Session Details

Zhiying You
2010 (Baltimore) Annual Meeting

Contributed Session
POWER AND SAMPLE SIZE OF ANALYSIS OF VARIANCE IN CLUSTER RANDOMIZED TRIALS

Session Details

Young Kim
2010 (Baltimore) Annual Meeting

Contributed Session
POWER IN THREE-ARM GENERIC DRUG TRIALS OF EQUIVALENCE

Session Details

Jon Yankey
2010 (Baltimore) Annual Meeting

Contributed Session
Practical Implications of Inter-Rater Agreement in a Randomized Controlled Clinical Trial

Session Details

Madzouka Kokolo
2010 (Baltimore) Annual Meeting

Contributed Session
PRE-EXPOSURE PROPHYLAXIS RESEARCH: A QUANTITATIVE ETHICS APPRAISAL

Session Details

Emily Van Meter
2010 (Baltimore) Annual Meeting

Contributed Session
PROPORTIONAL ODDS MODEL FOR DOSE FINDING CLINICAL TRIAL DESIGNS WITH ORDINAL TOXICITY GRADING

Session Details

Marian Lake
2010 (Baltimore) Annual Meeting

Contributed Session
PROTECTING THE RIGHTS OF PREGNANT WOMEN IN RESEARCH: EXPERIENCE OF A PERINATAL RESEARCH CONSORTIUM

Session Details

Heather Eng
2010 (Baltimore) Annual Meeting

Contributed Session
Providing Integrated Access to Clinical Trials Data from Multiple Systems

Session Details

Liza Dawson
2010 (Baltimore) Annual Meeting

Contributed Session
Public health equipoise and standards of care in clinical research

Session Details

Steven Weiner
2010 (Baltimore) Annual Meeting

Contributed Session
Publications Management in a Multicenter Clinical Trials Network

Session Details

Selma Kunitz
2010 (Baltimore) Annual Meeting

Contributed Session
QUALITY ASSURANCE AND SITE VISITS FOR THE NATIONAL INSTITUTES OF HEALTH

Session Details

Melissa Engle
2010 (Baltimore) Annual Meeting

Contributed Session
Quality Assurance Improvements in the Tuberculosis Trials Consortium

Session Details

Thomas Bruckner
2010 (Baltimore) Annual Meeting

Contributed Session
Randomization in surgical trials

Session Details

Jeannette Lee
2010 (Baltimore) Annual Meeting

Contributed Session
Recruitment to a Clinical Trial of Botanical Therapy for Benign Prostatic Hyperplasia

Session Details

Zhiying You
2010 (Baltimore) Annual Meeting

Contributed Session
RELATIVE EFFICACY AND SAMPLE SIZE FOR CLUSTER RANDOMIZED TRIALS WITH VARIABLE CLUSTER SIZES

Session Details

Stacey Slone
2010 (Baltimore) Annual Meeting

Contributed Session
ROBUSTNESS OF MODIFIED VERSIONS OF THE CONTINUAL REASSESSMENT METHOD IN SELECTING A PHASE I TRIAL DESIGN

Session Details

Shamaila Anwar
2010 (Baltimore) Annual Meeting

Contributed Session
SAFETY REPORTING IN STROKE REHABILITATION TRIALS

Session Details

Stephanie Shook
2010 (Baltimore) Annual Meeting

Contributed Session
Sample Size Estimation and Interim Monitoring Strategies for the Randomized Placebo-Phase Design

Session Details

Linda Ferrari
2010 (Baltimore) Annual Meeting

Contributed Session
SCANNING SOFTWARE: A TOOL FOR ARCHIVAL OF DATA COLLECTION FORMS USED IN THE ASTHMA CLINICAL RESEARCH NETWORK (ACRN) AND THE CHILDHOOD ASTHMA RESEACH AND EDUCATION (CARE) NETWORK

Session Details

Paula McGee
2010 (Baltimore) Annual Meeting

Contributed Session
SELECTION OF A CLINICAL RESPONSE CRITERION

Session Details

Tze Lai
2010 (Baltimore) Annual Meeting

Contributed Session
Sequential Clinical Trial Designs for Validation and Development of Biomarker-Based Personalized Therapies

Session Details

Wenle Zhao
2010 (Baltimore) Annual Meeting

Contributed Session
Sequential Relaxed Permuted Block Randomization

Session Details

Frank Molnar
2010 (Baltimore) Annual Meeting

Contributed Session
Should FDA, EMEA, Health Canada, CONSORT accept Last-Observation-Carried-Forward Analyses? A Systematic Review of Dementia Drug RCTs.

Session Details

J Athene Lane
2010 (Baltimore) Annual Meeting

Contributed Session
SITE MONITORING SYSTEMS FOR CLINICAL TRIALS: A SYSTEMATIC REVIEW

Session Details

Katherine Hammerhofer, R.N.
2010 (Baltimore) Annual Meeting

Contributed Session
Solving the Issues and Challenges of Clinical Trial Management in a Large Academic Medical Center and Research Institution

Session Details

Geraldine Baggs
2010 (Baltimore) Annual Meeting

Contributed Session
SPEED TO MARKET: A NUTRITION INDUSTRYS EXPERIENCE IN STREAMLINING THE PEDIATRIC CLINICAL RESEARCH PROCESS

Session Details

Robert Lindblad, MD
2010 (Baltimore) Annual Meeting

Contributed Session
STANDARDIZING AND STREAMLINING SAFETY REPORTING IN SUBSTANCE ABUSE TRIALS

Session Details

Valerie Brueton
2010 (Baltimore) Annual Meeting

Contributed Session
STRATEGIES TO REDUCE ATTRITION IN RANDOMISED TRIALS: A SYSTEMATIC REVIEW.

Session Details

Julie Murdoch
2010 (Baltimore) Annual Meeting

Contributed Session
Success Rate of Telephone and Questionnaire Reminders in a Surgical Randomised Control Trial

Session Details

Susan Campbell
2010 (Baltimore) Annual Meeting

Contributed Session
SUPPORTING THE MANAGEMENT OF PRAGMATIC RANDOMIZED CONTROLLED TRIALS: DEVELOPMENT OF THE TRIAL MANAGEMENT TOOL

Session Details

Christopher Coffey
2010 (Baltimore) Annual Meeting

Contributed Session
Survey on the Use of Adaptive Designs in the Journal of the American Medical Association (2007-08)

Session Details

Melania Pintilie
2010 (Baltimore) Annual Meeting

Contributed Session
The analysis of case cohort design in the presence of competing risks with application to the analysis of the effect of treatment for Hodgkin Lymphoma on cardiac events.

Session Details

Jennifer Menzies
2010 (Baltimore) Annual Meeting

Contributed Session
THE CONTROL OF HYPERTENSION IN PREGNANCY STUDY (CHIPS) TRIAL RESEARCH FORUM - A COMMON MEETING GROUND FOR DISCUSSION

Session Details

Sunny Chan
2010 (Baltimore) Annual Meeting

Contributed Session
The Design and Implementation of a Compliance Monitoring Program for Multicentre Randomized Control Trials

Session Details

Leslie McClure
2010 (Baltimore) Annual Meeting

Contributed Session
THE EFFECT OF AN UNPLANNED SAMPLE SIZE RE-ESTIMATION ON THE TYPE I ERROR RATE

Session Details

Katrina Jones
2010 (Baltimore) Annual Meeting

Contributed Session
THE EFFECTS OF CLINICAL COORDINATOR TURNOVER ON A LARGE MULTI-CENTER TRIAL

Session Details

Joerg Hasford
2010 (Baltimore) Annual Meeting

Contributed Session
The European Clinical Trials Directive 2001/20/EC on debate - seen from an Ethics Review Board (ERB) point of view

Session Details

Michael Walsh
2010 (Baltimore) Annual Meeting

Contributed Session
The fragility index: A metric to describe the reliability of clinical trial results

Session Details

Michael Walsh
2010 (Baltimore) Annual Meeting

Contributed Session
The fragility index: a pilot data for a new metric to describe the reliability of clinical trial results

Session Details

Kyounghwa Bae
2010 (Baltimore) Annual Meeting

Contributed Session
The Implementation of a Clinical Trial Using Time-to-Event Continual Reassessment Method (TITE-CRM) in a Cooperative Group Setting; Radiation Therapy Oncology Group (RTOG) 0813

Session Details

Sue Ross
2010 (Baltimore) Annual Meeting

Contributed Session
The patient's perspective on evidence needed to support the regulation and adoption of new surgical devices: preliminary results from a qualitative pilot study

Session Details

Gail Mallett
2010 (Baltimore) Annual Meeting

Contributed Session
The Role of the Nurse Coordinator in a Large Clinical Trial Network in Maternal Fetal Medicine

Session Details

Lea Drye
2010 (Baltimore) Annual Meeting

Contributed Session
THE STATE AND NATURE OF CLINICAL TRIALS: 1966 - 2008

Session Details

Sara Pressel
2010 (Baltimore) Annual Meeting

Contributed Session
THE UTILITY OF POST-TRIAL FOLLOW-UP OF PARTICIPANTS - THE ANTIHYPERTENSIVE AND LIPID-LOWERING TREATMENT TO PREVENT HEART ATTACK TRIAL EXPERIENCE

Session Details

Elizabeth Sugar
2010 (Baltimore) Annual Meeting

Contributed Session
The Van der Waerden Approach: a rank-based technique to account for non-Gaussian distributions in statistical modeling

Session Details

John Dills
2010 (Baltimore) Annual Meeting

Contributed Session
Timing Interventions in a Depression Care Management Trial

Session Details

Jane Hongyuan Zhang
2010 (Baltimore) Annual Meeting

Contributed Session
TITRATION MANAGEMENT OF STUDY DRUGS IN THE VA NEPHRON-D TRIAL

Session Details

James Bost
2010 (Baltimore) Annual Meeting

Contributed Session
TRANSITIONING A DATA COORDINATING CENTER

Session Details

James Bost
2010 (Baltimore) Annual Meeting

Contributed Session
TRANSITIONING A DATA COORDINATING CENTER

Session Details

Frani Averbach
2010 (Baltimore) Annual Meeting

Contributed Session
Transitioning Clinical Phase of Multi-Center Trial to Centralized Annual Follow-up: Dont Miss a Beat

Session Details

Alexia Iasonos
2010 (Baltimore) Annual Meeting

Contributed Session
Two-stage continual reassessment method that determines dose-escalation based on individual toxicity grades

Session Details

ROSEMARY KNIGHT
2010 (Baltimore) Annual Meeting

Contributed Session
txt2stop (Stop Smoking with Mobile Phones). Methods used to improve recruitment

Session Details

Nicola Mills
2010 (Baltimore) Annual Meeting

Contributed Session
UNDERSTANDING TREATMENT PREFERENCES DURING RECRUITMENT INTO RANDOMISED CONTROLLED TRIALS: A QUALITATIVE STUDY

Session Details

Michael Terrin
2010 (Baltimore) Annual Meeting

Contributed Session
USE OF MONTE CARLO SIMULATION TO DETERMINE MINIMAL CLINICALLY IMPORTANT DIFFERENCES (MCID) IN RELATION TO STATISTICAL POWER FOR NON-CLINICAL EFFECTS AND AN INHOMOGENEITY IN THE INTERPRETATION OF NUMBER NEEDED TO TREAT

Session Details

Mark Espeland
2010 (Baltimore) Annual Meeting

Contributed Session
USE OF THE TELEPHONE INTERVIEW FOR COGNITIVE STATUS (TICS) TO SCREEN VOLUNTEERS FOR CLINICAL TRIALS OF PHYSICAL ACTIVITY AND COGNITIVE TRAINING INTERVENTIONS: THE SENIORS HEALTH AND ACTIVITY RESEARCH PROGRAM

Session Details

Kristopher Kaufman
2010 (Baltimore) Annual Meeting

Contributed Session
Using a Database and Related Web Based Forms to Improve Efficiency in Accruing Patients to Phase 1 Protocols

Session Details

Todd Hardin
2010 (Baltimore) Annual Meeting

Contributed Session
Using caBIG Clinical Trials Management Suite to achieve continuity of care

Session Details

Kousick Biswas
2010 (Baltimore) Annual Meeting

Contributed Session
USING MICROSOFT GROOVE AS A DATA TRANSMISSION PLATFORM IN A LARGE SCALE EPIDEMIOLOGICAL STUDY WITH ASIAN AND AFRICAN SITES

Session Details

Jason Harris-Talley
2010 (Baltimore) Annual Meeting

Contributed Session
Video Productions in SELECT: Effective Tools for Staff Learning and Participant Motivation in Clinical Trials

Session Details

William Elgie
2010 (Baltimore) Annual Meeting

Contributed Session
WEB-BASED MANAGEMENT OF PHASE I PROTOCOLS IN A COOPERATIVE GROUP SETTING.

Session Details

Kath Starr
2010 (Baltimore) Annual Meeting

Contributed Session
WHAT THEY SAY AND WHAT THE DOCTORS SAY: PATIENT REPORTED VS PRIMARY CARE PHYSICIAN CONFIRMED URINARY TRACT INFECTIONS

Session Details

Barbara Hawkins
2010 (Baltimore) Annual Meeting

Contributed Session
Will the Last Person to Leave Please Turn Out the Lights?

Session Details

Jeffrey Klein
2010 (Baltimore) Annual Meeting

Contributed Session
WWW.IIRESEARCH.ORG: AN INTERNET PLATFORM FOR INVESTIGATOR INITIATED RANDOMIZED CLINICAL TRIALS

Session Details

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