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Begin by selecting filters below to narrow the list of desired registrants listed. Note that only names and affiliations are displayed on this page, but Excel downloads contain complete registration dataset. To download your search result click the button below. If you have any questions, comments or feedback, please contact us at info@sctweb.org.
| First Name | Last Name | Affiliation | Location | Telephone | Website | Address 1 | Address 2 | Address 3 | Preferred Contact Method | Credentials | Professional Expertise | DMC Areas of Experience | Publications Link 1 | Publications Link 2 | Publications Link 3 | Biography | CV Link | Years of Clin Research Experience | Describe CT Experience | Served on a DMC before? | Anticipated DMC Role(s) | Willing to Serve as DMC Chair? | Served DMC 1 | Served DMC 2 | Served DMC 3 | Served DMC 4 | Served DMC 5 | Chaired DMC 1 | Chaired DMC 2 | Chaired DMC 3 | Chaired DMC 4 | Chaired DMC 5 | Want Apprenticeship | Willing to Mentor | |
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| Scott | Evans | George Washington University | North America (Maryland, Eastern Time) | sevans@bsc.gwu.edu | (301) 881-9260 | https://publichealth.gwu.edu/departments/biostatistics-and-bioinformatics/scott-evans | 6110 Executive Boulevard | Suite 750 | Rockville, MD 20852-3943 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Infectious Disease | - Cardiovascular Disease - Critical Care Medicine - Diabetes - Immunology - Infectious Disease - mHealth/Mobile Devices - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Respiratory Disease - Surgery - Virology | http://www.ncbi.nlm.nih.gov/sites/myncbi/scott.evans.1/bibliography/40609797/public/?sort=date&direction=ascending | https://publichealth.gwu.edu/departments/biostatistics-and-bioinformatics/scott-evans | https://publichealth.gwu.edu/departments/biostatistics-and-bioinformatics/scott-evans | 22 | I have designed, monitored, analyzed and reported the results of numerous clinical trials in multiple disease areas. I have taught clinical trials for 15 years and have 3 books on clinical trials and associated methodologies. I have the the statistical and data management center for clinical trial networks for 20 years. I have served on more than 100 DMCs and have served on FDA advisory committees that review the result of trials. | Yes | - Statistician | Yes | COMET-ICE COVID-19, Vir | DAPA-MI registry trial, AstraZeneca | Ocrelizumab in RRMS/PPMS, Roche | PALLAS, Breast International Group | Plazomicin for CRE infections, Achaogen | Chair, Adolescent Medicine Trials Network (ATN), NICHD/NIH | Chair, Microbial restoration in Clostridium difficile Associated Disease (CDAD), NIAID | Chair, Varenicline tartrate for smoking cessation, Pfizer | Chair, ABP 710 for Rheumatoid Arthritis, Amgen | Chair, GS-9876 for Cutaneous Lupus Erythematosus, Gilead | No | Yes | |||
| Frank | Rockhold | Duke University Medical Center | North America (North Carolina, Eastern Time) | frank.rockhold@duke.edu | (919) 668-1073 | https://scholars.duke.edu/person/frank.rockhold | 360 Carolina Crossings Dr. | Apex, NC 27523 | PhD Master's degree Bachelor's degree | - Biostatistics - Clinical Trials - Other (Pharmacovigilance) | - Cardiovascular Disease - Diabetes - Immunology - Infectious Disease - mHealth/Mobile Devices - Neurology/Neurosurgery - Oncology - Ophthalmology - Pediatrics - Pulmonary Disease - Respiratory Disease - Surgery - Virology - Other (Vaccines, Dermatology, Rare Diseases) | https://scholars.duke.edu/person/frank.rockhold | https://www.ncbi.nlm.nih.gov/myncbi/collections/mybibliography/ | Frank is currently Professor of Biostatistics and Bioinformatics at the Duke University Medical Center, Affiliate Professor of Biostatistics at Virginia Commonwealth University, and Managing Partner of HunterRockhold, Inc. He has diverse research interests and consulting experience including trial design, data monitoring, benefit/risk, and pharmacovigilance and has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. His career includes numerous senior management positions in industry, most recently as Chief Safety Officer and senior vice president for pharmacovigilance at GSK. Dr. Rockhold has served as Chairman of the board for CDISC and president of the Society for Clinical Trials. He also served on the inaugural PCORI Clinical Trials Advisory Board and is currently Chairman of the board of the Frontier Science Research Foundation and an advisor to EMA. Frank serves on numerous Independent Data Monitoring Committees. Dr. Rockhold holds a BA in Statistics from The University of Connecticut, an ScM in Biostatistics from The Johns Hopkins University, and a PhD in Biostatistics from the Medical College of Virginia at Virginia Commonwealth University. He is an Elected Fellow of both the American Statistical Association, the Society for Clinical Trials, and the Royal Statistical Society. He is an Accredited Professional Statistician, PStat®, and a Chartered Statistician, CStat. | https://scholars.duke.edu/person/frank.rockhold | 15 | 45 years of experience designing, running, and analyzing clinical trials. Have been involved in one aspect or another in >2000 clinical trials. | Yes | - Statistician - Other (Chair) | Yes | SURPASS | NATRON | MESSINA | MERCK V-114 program (17 trials) | SUMITT | Apple Heart Study | Roziamb Rare Disease Program | Rhythm Rare Disease Program | ResTORbio | No | Yes | ||||
| David | DeMets | University of Wisconsin-Madison | North America (Wisconsin, Central Time) | demets@biostat.wisc.edu | (608) 335-6368 | https://biostat.wiscweb.wisc.edu/staff/demets-david-l/ | 6333 Landfall Drive, Madison Wisconsin 53705 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Epidemiology - Oncology - Ophthalmology - Pulmonary Disease | - Cardiovascular Disease - Diabetes - Immunology - Infectious Disease - Nephrology - Oncology - Ophthalmology - Pediatrics - Pulmonary Disease - Respiratory Disease - Surgery | https://biostat.wisc.edu/~demets | David L. DeMets, PhD is currently the Max Halperin Professor of Biostatistics, Emeritus, and founder and former Chair of the Department of Biostatistics and Medical Informatics at the University of Wisconsin – Madison. He received his PhD in biostatistics in 1970 from the University of Minnesota. Following a postdoctoral appointment in the Division of Computer Research and Technology at the National Institutes of Health (1970-72), he spent ten years (1972-1982) at the National Heart, Lung and Blood Institute at the National Institutes of Health where he was a member of and later became chief of the Biostatistics Branch. In 1982, he joined the University of Wisconsin and later founded the Department of Biostatistics and Medical Informatics which he chaired until 2009. In 2017, He became emeritus professor. He has co-authored four texts, Fundamentals of Clinical Trials, Data Monitoring in Clinical Trials: A Case Studies Approach. Data Monitoring Committees in Clinical Trials: A Practical Perspective, and Statistical Methods for Clinical Trials. He has served on numerous NIH and industry-sponsored Data Safety and Monitoring Committees for clinical trials in diverse disciplines. He served on the Board of Directors of the Society for Clinical Trials (1983-1987) American Statistical Association (1987-89), as well as having been President of the Society for Clinical Trials (1989) and President of the Eastern North American Region (ENAR) of the Biometric Society (1993). In addition, he was Elected Fellow of the International Statistics Institute in 1984, the American Statistical Association in 1986, the Association for the Advancement of Science in 1998, the Society for Clinical Trials in 2006 and the American Medical Informatics Association in 2008. In 2013, he was elected as a member of the Institute of Medicine/now the National Academy of Medicine. His research interests include the design, data monitoring and analysis of clinical trials, especially large Phase III randomized clinical trials. He is well known for his work on sequential statistical methods for monitoring interim data for early evidence of intervention benefit or possible harm. | https://biostat.wisc.edu/~demets | 50 | For the past 50 years, I have been involved in the design, conduct, interim monitoring, data management, final analyses, publication and regulatory review of randomized clinical trials in cardiology, pulmonary disease, ophthalmology, oncology, diabetes, AIDS, Ebola, and most recently Covid treatment trials. The interventions that I have been involved include drugs, medical devices, biologics, vaccines, surgical interventions and behavioral modification trials. i have engaged in therapeutic trials,both primary and secondary prevention trials, and diagnostic trials | Yes | - Statistician | Yes | Cardiac Arrhythmia Suprression Trial (CAST) | Women's Health Initiative (WHI) | MERIT-HF | COMPANION | COPERNICUS | UPLIFT | AHEFT | FIT | No | Yes | |||||||
| John | McMurray | University of Glasgow/Queen Elizabeth University Hospital | Europe | john.mcmurray@glasgow.ac.uk | +441413303479 | https://www.gla.ac.uk/researchinstitutes/icams/staff/johnmcmurray/ | BHF Glasgow Cardiovascular Research Centre | 126 University Place, Glasgow G12 8TA | Scotland UK | MD | - Cardiovascular Disease - Clinical Trials | - Cardiovascular Disease - Diabetes - Nephrology | https://scholar.google.com/citations?user=n0ZdRMoAAAAJ&hl=en | Prof McMurray is currently Professor of Medical Cardiology and Deputy Director (Clinical) of the Institute of Cardiovascular and Medical Sciences and honorary Consultant Cardiologist at the Queen Elizabeth University Hospital, Glasgow. Prof McMurray’s primary research interests are in heart failure, the cardiovascular consequences of diabetes and chronic kidney disease, atrial fibrillation and coronary heart disease, with a focus on clinical trials and epidemiology. He is, or was, the principal investigator, member of the executive committee or steering committee member in several large trials in his areas of interest. Professor McMurray served as the inaugural Eugene Braunwald Scholar in Cardiovascular Disease at the Brigham and Women’s Hospital, Boston, and visiting Professor of Medicine, Harvard University, Boston, Massachusetts USA 2010/2011. He is a Past-President of the Heart Failure Association of the ESC and is involved in guideline writing and the editorial boards of several leading journals. He is a Highly Cited Researcher (https://recognition.webofsciencegroup.com/awards/highly-cited/2019/) and has a H-index of 200 (https://scholar.google.com/citations?user=n0ZdRMoAAAAJ&hl=en). He has won several awards, including the Stokes Medal of the Irish Cardiac Society. In June 2015, Professor John McMurray and Professor Salim Yusuf (McMaster University, Hamilton Ontario, Canada) were jointly awarded the 8th Arrigo Recordati International Prize for Scientific Research (for outstanding contributions in secondary prevention and risk reduction strategies in patients with cardiovascular diseases). Prof McMurray is the recipient of the Mackenzie Medal, which is awarded by the British Cardiovascular Society in recognition of outstanding service to British Cardiology. He is also the recipient of the Louis and Artur Lucian Award for Research in Circulatory Diseases, which is awarded each year by McGill University, Montreal. This international award recognises outstanding research in the field of circulatory diseases by a scientific investigator, or group of investigators, whose contribution to knowledge in this field is deemed worthy of special recognition. Professor McMurray was awarded an OBE in 2019 by Her Majesty The Queen, in recognition of his services to cardiovascular research. In 2020 he was awarded the Gold Medal of the European Society of Cardiology, which the society describes as “the highest honour it can bestow on exceptional scientists for their contribution to cardiovascular medicine”. | 30 | Executive/Steering Committee chair/member; Endpoint Adjudication Committee chair/member; DSMB chair/member - multiple trials | Yes | - Medical expert | Yes | ASCEND PLUS Chair - new trial due to start | MONITOR-HF Chair | VICTORIA Chair | SOCRATES trials chair | SPIRE Chair | No | Yes | |||||||||
| Pardeep | Jhund | University of Glasgow | Europe | pardeep.jhund@glasgow.ac.uk | 07917725027 | https://www.gla.ac.uk/researchinstitutes/icams/staff/pardeepjhund/ | 126 University Place | University of Glasgow | PhD MD Master's degree | - Bioinformatics - Biostatistics - Cardiovascular Disease - Clinical Informatics - Clinical Trials - Epidemiology | - Cardiovascular Disease - Diabetes | https://pubmed.ncbi.nlm.nih.gov/?term=jhund+%5Bau%5D&sort=date | https://scholar.google.com/citations?user=UKVyHUgAAAAJ&hl=en&oi=ao | https://www.gla.ac.uk/researchinstitutes/icams/staff/pardeepjhund/ | 20 | I am cardiologist with training in clincal trials which is one of my main research areas along with statisitca and epidemiology. My interest in clinical trials started during my undergraduate training where I conducted a randomised cross over trial. Since that time I have been involveed in many clinical trials, both sponsored by industry and leading investigator initiated trials. I have published widely in the area of clinical trials and therapy and have help a number of leadership posistions in large multinational trials including as a National Leader and Chair of the Endpoint Commitee. I have extensive experience of endpoint adjudication and more recently have served on a DMC for a device trial and am embarking on a DMC for a diabetes drug. On these DMC I am able not only to provide my clinical input but also statistical interpretation. In addition to being a practicing cardiologist and cardiovascular researcher I have a Masters degree and PhD in epidemiology and a strong statistical background. I am currently an Associated Statistical Editor for Circulation:Heart Failure. | Yes | - Medical expert - Other (Although I do not perform the statistical analysis for DMCs I have a strong statistical background and can advise on statistical matters. ) | No | Randomised comparison of the effect of haemodynamic monitoring with CardioMEMS in addition to standard care on quality of life and hospitalisations in patients with chronic heart failure (MONITOR-HF) | ASCEND (A Study of Cardiovascular Events iN Diabetes) PLUS - a study of semaglutide in diabetes | Yes | No | ||||||||||||
| Charles | Hennekens | Charles E. Schmidt College of Medicine, Florida Atlantic University | North America (Florida, Eastern Time) | PROFCHHMD@prodigy.net | 561-393-8845 | 2800 S. Ocean Blvd. PHA | Boca Raton, FL 33432, USA | PhD MD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Epidemiology | - Cardiovascular Disease - Nephrology - Oncology - Pediatrics | 20 | Yes | - Medical expert | Yes | No | Yes | |||||||||||||||||||
| David | Kerr | Cytel | North America (Washington, Pacific Time) | david.kerr@cytel.com | (206) 577-0217 | https://www.cytel.com/ | 2601 4th Avenue | Suite 200 | Master's degree | - Biostatistics - Clinical Trials | - Cardiovascular Disease - Critical Care Medicine - Immunology - Infectious Disease - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pediatrics - Pulmonary Disease - Respiratory Disease - Surgery - Virology | https://www.linkedin.com/in/dmcdavid/ | I have attended ~700 DSMB meetings representing ~150 DSMBs over the past 25 years. Typically my role has been the independent (reporting) statistician - helping to create DSMB outputs and facilitate a smooth DSMB meeting. I have served on DSMB as voting member on 5 DSMBs. Based on these experiences I have presented at conferences (BASS, JSM) on best practices for DSMBs. | https://www.linkedin.com/in/dmcdavid/ | 25 | I have 25 years of receiving, analyzing, and reporting clinical trial data. | Yes | - Statistician | Yes | Phase I/II Sarcoma | Phase II Lymphoma | Phase III Uveitis | Phase III Prader-Willi Syndrome | Phase II HIV | No | Yes | |||||||||
| David | Reboussin | Wake Forest University School of Medicine | North America (North Carolina, Eastern Time) | drebouss@wakehealth.edu | (336) 716-6844 | Public Health Sciences - Biostatistics | Medical Center Blvd | Winston-Salem NC 27157 | - Biostatistics - Cardiovascular Disease - Clinical Trials - Diabetes - Epidemiology - Other (Aging, Nutrition) | - Cardiovascular Disease - Critical Care Medicine - Diabetes - Nephrology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease | After graduating with a PhD from the Dept of Statistics at UW Madison in 1992, I joined the faculty of the Dept of Biostatistics at the Wake Forest University School of Medicine, where I am now a tenured full professor. | 35 | My main career focus in on clinical trials. I was PI of the Coordinating Center for the SPRINT trial and a Coordinating Center statistician for the ACCORD and Look AHEAD trials in addition to four other larger multicenter trials. I have done some methods research on group sequential testing and wrote publicly available software implementing the Lan-DeMets spending function approach. I am also a co-author of a textbook on clinical trials, Fundamentals of Clinical Trials, along with Lawrence Friedman, Curt Furberg, Dave DeMets and Chris Granger. | Yes | - Statistician | Yes | Stop Atherosclerosis in Native Diabetics (SANDS) | Preventing Overweight Using Novel Dietary Strategies (POUNDS LOST) | Diabetes Prevention Project Outcomes Study (DPP OS) | Trial of Late Surfactant (TOLSURF) | MIND Diet Trial | Pediatric Emergency Care Applied Research Network (PECARN) | No | Yes | |||||||||||
| Richard | Chappell | University of Wisconsin School of Medicine and Public Health | North America (Wisconsin, Central Time) | chappell@stat.wisc.edu | (608) 229-6541 | https://biostat.wiscweb.wisc.edu/staff/chappell-richard-j/ | 2715 Marshall Court | 313 | PhD | - Biostatistics - Clinical Trials - Epidemiology - Oncology | - Cardiovascular Disease - Infectious Disease - Neurology/Neurosurgery - Oncology - Ophthalmology - Pediatrics - Respiratory Disease - Surgery | https://scholar.google.com/scholar?hl=en&as_sdt=0%2C50&q=richard+chappell&oq= | Rick Chappell, Ph.D., is Professor in the Departments of Biostatistics and Medical Informatics and of Statistics at the University of Wisconsin Madison. His methodologic research is in the areas of Phase I clinical trials, non-inferiority trials, designs for randomized clinical trials, models for radiation biology, and survival analysis. He is Fellow of the American Statistical Association and the Society for Clinical Trials, has served as President of the Society for Clinical Trials, and is serving or has served on four FDA advisory committees and approximately 30 data safety monitoring boards for the NIH, VA, and industry. | Yes | - Statistician | Yes | 1/2021 - Member, DSMB for an NIA-funded study "Cognitive Screening Made Easy for Primary Care Providers". | 7/2020 - Member, DSMB for the NRG cooperative oncology group. | 10/2018 - Member, DSMB for AXS-05-AD-301, an AXSOME pharmaceutical trial to Assess the Efficacy and Safety of AXS-05 for the Treatment of Agitation in Subjects with Dementia of the Alzheimer's Type. | 7/2018 - Member, DSMB for TRUST, an NIH-sponsored trial on intravitreal autologous bone marrow stem cell therapy for retinal vein occlusion. | 4/2014-4/2018 - Member, DSMB for "Safety, Tolerability, and Efficacy Assessment of Isradipine for PD (STEADY-PD) III", a randomized clinical trial for the treatment of Parkinson's Disease sponsored by the National Institute of Neurological Disorders and Stroke. | No | Yes | ||||||||||||
| Barry | Davis | University of Texas School of Public Health | North America (Texas, Central Time) | barry.r.davis1@gmail.com | 832-687-4037 | 3106 Stoney Mist Dr | Sugar Land, TX 77479 | PhD MD | - Biostatistics - Cardiovascular Disease - Clinical Informatics - Clinical Trials - Diabetes - Epidemiology - Neurology/Neurosurgery - Ophthalmology | - Cardiovascular Disease - Diabetes - Nephrology - Neurology/Neurosurgery - Ophthalmology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Respiratory Disease | http://www.ncbi.nlm.nih.gov/sites/myncbi/barry.davis.1/bibliography/46206763/public/?sort=date&direction=ascending. | https://scholar.google.com/citations?user=Ioga5YIAAAAJ&hl=en | Professor Davis received his BS in Life Sciences from the Massachusetts Institute of Technology and his MS and PhD in Applied Mathematics from Brown University as well as an MD from the University of California, San Diego School of Medicine. For 35 years he has been at the Coordinating Center for Clinical Trials at the University of Texas School of Public Health serving as Deputy Director and now Director. He was the Principal Investigator and Director of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) and the coordinating center director for several other well-known cardiovascular clinical trials. He served as President of the Society for Clinical Trials (1999-2000) and as Chair of the Biometrics Section of the American Statistical Association (2003) and currently serves on the FDA Cardiovascular and Renal Drugs Advisory Committee (2013- 2020). He is a Fellow of the American Statistical Association, the Society for Clinical Trials, the American Association for the Advancement of Science, the American Heart Association Council on Epidemiology and Prevention, the American College of Preventive Medicine, and the American Society of Hypertension, and is an elected member of the International Statistical Institute. He has served on numerous data monitoring committees for federally- and industry-funded clinical trials | https://daj9cl0xcfutq.cloudfront.net/cv/davis.pdf | 38 | • MD – Public Health and General Preventive Medicine • PhD – Applied Mathematics (Statistics) • Professor of Biostatistics and Data Science, University of Texas School of Public Health (UTSPH) • Director of UTSPH Coordinating Center for Clinical Trials • Society for Clinical Trials – President (2000) and Fellow (2007) • FDA Cardiorenal Drugs Advisory Committee member 2013-2020 • Reported to and served on DMC’s (including several as Chair) for over 150 NIH and industry trials on cardiovascular disease, eye disease, GI disease, arthritis, infectious disease, cancer, hematology, neurology, diabetes, psychiatry, dental disease, etc. | Yes | - Medical expert - Statistician | Yes | NHLBI SPRINT trial | NEI OHTS trial | NINDS ARUBA trial | Amgen Fourier trial | NHLBI CABANA trial | NEI OHTS trial | NHLBI CAPTION trial | NHLBI MEDFOCUS trial | No | Yes | ||||||
| Jean | Rouleau | University of Montreal | North America (Canada, Eastern Time) | jean.rouleau@umontreal.ca | 15149533339 | 26 Glencoe Ave, Outremont, Québec, Canada H3T 1P9 | MD | - Cardiovascular Disease - Clinical Trials | - Cardiovascular Disease - Diabetes - Other (Vaccines, COVID-19) | Dr. Jean L. Rouleau currently practices cardiology at the Montreal Heart Institute (MHI). Until November 2015, he was the Scientific Director of the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research. The Dean of the Faculty Medicine at Université de Montréal from 2003 to 2010 as well as a respected cardiologist and world-renowned researcher, Dr. Rouleau has also taught at the University of Toronto and was Director of Cardiology and the Cardiovascular Program at the University Health Network (UHN) and Mount Sinai Hospital in Toronto. Through his work at many university hospitals, he has developed a deep understanding of teaching, research and care environments. He received his Doctor of Medicine from the University of Ottawa and did clinical training at McGill University and a postdoctoral research fellowship in San Francisco. Dr. Rouleau is also regarded as an excellent teacher, having influenced a generation of students in both cardiology and medicine. However, it is in the biomedical sciences that Dr. Rouleau has made a reputation in Canada through his cardiology research in heart failure, post-infarction, ventricular remodeling, neurohormones, therapeutic interventions, ventricular function and the development of heart failure post-infarction. His publication list is counting more than 500 articles, 305 abstracts and 7 book chapters. | 45 | I have chaired three trial, including the STICH trial, and have been on the Executive or Steering committee of over 30 trials. I have or am serving as chair of 13 DSMBs and as a member of another 39 DSMBs. | Yes | - Medical expert | Yes | TREAT, Trial Reduce Cardiovascular Events with Aranesp Therapy | MIPOMERSEN, Phase 3 Study of mipomersen for the treatment of heterozygous familial hypercholesterolemia (heF) | C DIFFENSE, Study of a Candidate Clostridium Difficile Toxoid Vaccine (Cdiffense) in Subjects at Risk for C. Difficile Infection | DAPA-CKD, A study to Evaluate the Effest of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with Chronic Kidney Disease | ARISTOTLE, Apixaban for Reduction In STroke and Other ThromboemboLic Events in Atrial Fibrillation | COLCORONA, Colchicine Coronavirus SARS Co-V2 trial | DREAM-HF, A double blind Randomized, Sham procedure controlled, parallel-group efficacy and safety study of allogenic mesonchrymal precussor cell (CEP-41750) in pts with chronic HF failure due to left ventricular systolic dysfunction of either ischemic or non-ischemic etiology | VALOR-HCM, Evaluation of the efficacy of mevacamten compared to placebo on patients diagnoses with symptomatic obstructive cardiomyopathy that are being referred for evaluation for invasive relief of LV outflow tract obstruction | EXSCEL, Exenatide Study of Cardiovasular Event Lowering | SELECT-ACS, Assessment of recombinant human monoclonal antibody against p-selectin in patients with non ST elevation myocardial infarction (non-STEMI) undergoing PCI | Yes | Yes | ||||||||
| Manisha | Desai | Stanford University | North America (California, Pacific Time) | manishad@stanford.edu | (650) 521-1686 | https://med.stanford.edu/qsu.html | 1701 Page Mill Drive | PhD Master's degree Bachelor's degree | - Bioinformatics - Biostatistics - Cardiovascular Disease - Clinical Informatics - Clinical Trials - Critical Care Medicine - Diabetes - Epidemiology - Immunology - Infectious Disease - mHealth/Mobile Devices - Nephrology - Neurology/Neurosurgery - Oncology - Pathology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Quality Improvement - Virology | - Cardiovascular Disease - Diabetes - Oncology - Psychiatry/Behavioral Sciences | 20 | I am PI of a platform protocol trial to identify therapeutics for mild to moderate COVID in the outpatient setting. I have over 20 years of experience designing clinical trials in cardiovascular medicine, oncology, diabetes and physical activity. In addition, I am PI of several Data Coordinating Centers. In this role we support DSMBs by serving as the Independent Statistical Group. Finally, I also enjoy serving on DSMBs both as a member and as chair. | Yes | - Statistician | Yes | Stanford Cancer Institute | ELITE Latinos Trial | Vida Sana Trial | Advanced Directives Study | BE WELL | RAINBOW Trial | RAINBOW-ENGAGE Trial | No | Yes | |||||||||||
| Rustam | Al-Shahi Salman | University of Edinburgh | Europe | Rustam.Al-Shahi@ed.ac.uk | 01314659618 | https://www.ed.ac.uk/profile/professor-rustam-al-shahi-salman | Centre for Clinical Brain Sciences (CCBS), Chancellor's Building | 49 Little France Crescent | Edinburgh. EH16 4SB | PhD MD | - Cardiovascular Disease - Clinical Trials - Neurology/Neurosurgery | - Cardiovascular Disease - Neurology/Neurosurgery - Radiology | https://orcid.org/0000-0002-2108-9222 | https://scholar.google.co.uk/citations?user=bHYjFIwAAAAJ&hl=en | https://www.ed.ac.uk/profile/professor-rustam-al-shahi-salman | https://www.ed.ac.uk/profile/professor-rustam-al-shahi-salman | 23 | Randomised controlled trial chief investigator 2020 – Antiplatelet Secondary Prevention International Randomised Trial After INtracerebral haemorrhaGe (ASPIRING)-Pilot Phase (NCT04522102) I designed and co-lead this international trial, funded by the National Health & Medical Research Council, Shenyang First People’s Hospital, Medical Health and Research Infrastructure Fund (Department of Health), and The University of Western Australia. 2020 – Cavernomas A Randomised Effectiveness (CARE) pilot trial (ISRCTN41647111) I designed and lead this trial in the UK & Ireland and obtained funding in response to an NIHR commissioned call (NIHR128694). 2020 – ENRICH-AF - EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (NCT03950076) Following the completion of my SoSTART pilot phase trial, I initiated this definitive main phase international trial (funded by, but run independently of Daiichi Sankyo), which I lead in the UK. 2017 – Triple therapy prevention of Recurrent Intracerebral Disease EveNts Trial (TRIDENT) (NCT02699645) I co-designed this international trial, funded by the National Health & Medical Research Council. 2017 – 2021 SoSTART: Start or STop Anticoagulants Randomised Trial (NCT03153150) I designed this UK trial, and obtained funding from CHSS & MRC (feasibility phase) and the BHF (pilot phase). 2012 – 2021 RESTART: REstart or STop Antiplatelets Randomised Trial (ISRCTN71907627) I designed and led this trial in the UK and obtained funding from the BHF. 2010 – 2016 PATCH: platelet transfusion in cerebral haemorrhage (Netherlands National Trial Register NTR1303) I led this trial in the UK and obtained funding from Chest Heart and Stroke Scotland. 2006 – 2014 ARUBA: a randomised trial of unruptured brain arteriovenous malformations (ISRCTN44013133) I was on the Executive Committee for this trial, funded by NIH and led this trial in the UK. 2006 – 2012 MASH-II: magnesium in aneurysmal subarachnoid haemorrhage (ISRCTN68742385) I led this international trial in the UK, funded by my MRC clinician scientist fellowship. Randomised controlled trial steering committee member (in addition to my chief investigator roles) 2021 – Tranexamic acid for hyperacute spontaneous Intracerebral Haemorrhage (TICH-3) Funded by NIHR HTA (NIHR129917). 2020 – STOPping Anticoagulation for isolated or incidental subsegmental Pulmonary Embolism (STOP-APE) (ISRCTN15645679) I am the independent chair of the Trial Steering Committee of this trial, funded by NHR HTA. 2019 – Statins In Intracerbral Hemorrhage (SATURN) (NCT03936361) I co-designed this trial, funded by the NIH via NINDS Stroke Trials Network (StrokeNet). 2019 – Phase II trial of Interleukin-1 receptor antagonist in intracerebral haemorrhage: BLOcking the Cytokine IL-1 in ICH (BLOC-ICH) (NCT03737344) Funded by NIHR. 2018 – Prevention Of Hypertensive Injury to the Brain by Intensive Treatment after IntraCerebral Haemorrhage (PROHIBIT ICH) (ISRCTN23416732) Funded by The Stroke Association. 2018 – Propranolol in Cerebral Cavernous Malformation (Treat_CCM) (NCT03589014) Funded by AIFA (Agenzia Italiana del Farmaco) 2018 – Desmopressin for reversal of antiplatelet drugs in Stroke due to Haemorrhage (DASH) (NCT03696121) Funded by NIHR RfPB 2017 – Study of Antithrombotic Treatment After IntraCerebral Haemorrhage (STATICH) (NCT03186729) I co-designed this trial, which is a sister trial to my RESTART and SoSTART trials. 2013 – 2018 TICH-2: Tranexamic acid for hyperacute primary Intracerebral Haemorrhage (ISRCTN93732214) Funded by NIHR HTA. Randomised controlled trial data monitoring committee member | Yes ( -Academia ) | - Medical expert | Yes | Stroke – an evaluation of Thrombectomy in the Ageing Brain - [including] where IV thrombolysis fails or IS contraindicated (STABILISE) (ISRCTN15698516) | Early versus late initiation of direct oral Anticoagulants in post-ischaemic stroke patients with atrial fibrillatioN (ELAN) (NCT03148457) | Stroke – an evaluation of Thrombectomy in the Ageing Brain - [including] where IV thrombolysis fails or IS contraindicated (STABILISE) (ISRCTN15698516) | Yes | No | |||||||||
| Haley | Hedlin | Stanford University | North America (California, Pacific Time) | hedlin@stanford.edu | https://med.stanford.edu/qsu/current-members/haley_hedlin.html | 3180 Porter Drive | Palo Alto CA, 94304 | PhD | - Biostatistics - Clinical Trials - mHealth/Mobile Devices | - Cardiovascular Disease - Critical Care Medicine - Infectious Disease - Pediatrics - Pulmonary Disease - Respiratory Disease | https://www.ncbi.nlm.nih.gov/myncbi/haley.hedlin.1/bibliography/public/ | https://scholar.google.com/citations?user=DFmcwYoAAAAJ&hl=en&oi=ao | https://med.stanford.edu/qsu/current-members/haley_hedlin.html | 10 | Yes | - Statistician | Yes | NHLBI Prevention of Pediatric Asthma Trials - 4 trials | TERPSICHORE | PIVOT NCT05654142 | Yes | Yes | |||||||||||||
| Lewis | Smith | Northwestern University Feinberg School of Medicine | North America (Illinois, Central Time) | ljsmith@northwestern.edu | 312-208-2608 | 1000 N Lake Shore Plaza | Apt 30C | Chicago, IL 60611 | MD | - Clinical Trials - Pulmonary Disease - Respiratory Disease | - Pulmonary Disease - Respiratory Disease | I am a Professor Emeritus of Medicine at Northwestern University’s Feinberg School of Medicine. I obtained an undergraduate degree from the City College of New York and a medical degree from the University of Rochester. I completed training in internal medicine at Strong Memorial Hospital (Rochester, NY) and in pulmonary medicine at Boston University. I joined the faculty of Northwestern University in 1979 and served as Chief of the Pulmonary and Critical Care Medicine Division from 1982 to 1998. I was Associate Director of the Office of Clinical Research and Training from 1988-2012, at which time I developed a training program in clinical investigation, which awards a Master of Science degree from the Graduate School. I served as a member of the Northwestern University Institutional Review Board (IRB) (1985-94) and its chair from 1987-1994. I also co-taught a graduate school course in clinical research ethics. I served as Associate Vice President for Research (2003-17) and as Director of the Center for Clinical Research (2010-17) in Northwestern University’s Clinical and Translational Sciences Institute. Recently, I was the “sponsor’s representative” for IND and IDE studies in which Northwestern University is the sponsor. I have had active laboratory-based and clinical research programs with funding from the Department of Veterans Affairs, the NIH, foundations and industry for more than 40 years. For the past 30+ years I studied various aspects of asthma pathogenesis and treatment. I led some of the initial studies exploring the role of leukotrienes and leukotriene modifiers in asthma. I was the Chicago site PI for the American Lung Association’s Asthma (now Airways) Clinical Research Centers (ALA-ACRC) program since its inception in 1999 until 2019, Co-PI and corresponding PI for the Chicago center of the NHLBI-supported AsthmaNet program, co-PI for the NHLBI PrecISE severe asthma network, and PI of a NIH-funded study exploring the role of soy isoflavones for the treatment of patients with poorly controlled asthma. I have been involved in three large epidemiology studies (CARDIA, MESA, SOL) that have provided novel insights into the prevalence and incidence of airway diseases and the factors that contribute to and protect against the development of asthma and COPD. I am a member of the Framingham Heart Study Observational Monitoring Board and serve on several clinical trial data and safety monitoring boards. | 35 | I have served on several data and safety monitoring committees over the last decade including the observational data and safety monitoring committee of the NIH/NHLBI-funded Framingham Heart Study. These committees have exposed me to a wide range of studies and the opportunity to work closely with many talented individuals who have served on the data and safety monitoring committees with me. This has been a valuable experience for how I manage my own studies and in addition it has helped me advise my colleagues at Northwestern about the role and importance of these committees. | Yes ( -Industry -Government ) | - Medical expert | Yes | Framingham Observational Safety and Monitoring Committee | NIH/FDA phase 4 study of the safety of long acting beta agonists when given along with inhaled corticosteroids | Phase 2 study of the prevention of COVID-19-induced pulmonary fibrosis | Phase 1 study of a novel inhaled agent for the treatment of pulmonay fibrosis | None | No | Yes | |||||||||||
| Kenneth | Mahaffey | Stanford | North America (California, Pacific Time) | kenneth.mahaffey@stanford.edu | (919) 819-2211 | 300 Pasteur Drive | Grant S-102 | Stanford, CA. 94305 | MD | - Cardiovascular Disease - Clinical Trials | - Cardiovascular Disease - Diabetes - Nephrology | 26 | Yes ( -Industry -Academia ) | - Medical expert | Yes | Yes | Yes | ||||||||||||||||||
| Nicole | Close | EmpiriStat, Inc. | North America (North Carolina, Eastern Time) | nclose@empiristat.com | (301) 524-4104 | http://www.empiristat.com | PO BOX 1604 | Kitty Hawk, NC 27949 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Diabetes - Epidemiology - Immunology - Infectious Disease - Nephrology - Neurology/Neurosurgery - Ophthalmology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Respiratory Disease - Surgery | - Cardiovascular Disease - Diabetes - Immunology - Infectious Disease - Neurology/Neurosurgery - Oncology - Psychiatry/Behavioral Sciences - Respiratory Disease | https://scholar.google.com/citations?view_op=list_works&hl=en&user=PvzYGkEAAAAJ | https://pubmed.ncbi.nlm.nih.gov/?term=Nicole+Close | Dr. Close's career was shaped by her training and mentoring under several outstanding biostatisticians that allowed her to take important clinical trial and statistical tools and apply them to a diverse therapeutic and device research background over the last 26 years. Following a mantra that the biostatistician should always be an educator, capacity building in Africa teaching clinical trial methodology and biostatistics in Kenya, Nigeria, Uganda and Tanzania was a highlight for her. After holding roles of Co-PI and PI for large clinical trials at a major Coordinating Center running NIH clinical trials, her career shifted focus to the biotech, pharma and device industry. Since starting her own statistical company in 2008, Dr. Close's focus has been providing biostatistical regulatory expertise for filings in the US, Canada, Asia and Europe; as well as developing sound methodology for registrational clinical trials and providing proper Sponsor oversight of those clinical trials for all Data Management, Statistical and Statistical Programming activities with CDISC compliance. After working on over 1000 protocols in various therapeutic, biologic, and device areas, she has been rewarded to have had 7 accepted NDAs and 2 MAAs for approval in the last 5 years. Providing sound statistical support for press releases and labeling, has been an added expertise as a consequence. Dr. Close has served on a number of DSMBs, consulted for adaptive design methodologies with the FDA, and has chaired 2 DSMBs with MDMA assisted therapies where Health Canada and the FDA requires the didacted Closed Session minutes after every meeting. Mentoring students and colleagues from other functional roles in drug and device development has always been a constant in her career, and it always will be a passion to continue. | https://www.linkedin.com/in/nicole-close-phd-047b577/ | 26 | Dr. Close has over 26 years of experience in designing, conducting and analyzing clinical trial data in a broad range of therapeutic and device areas. Her background is slightly dominated by cardiovascular, diabetes and infectious diseases, but she is also successful in orthopedics, oncology, transplantation, and immunology to name a few. While trained as a frequentist, Dr. Close does design and defend adaptive trial designs with regulatory agencies; including interim analyses, randomization methodologies, and blinded sample size re-estimations. She is a key advisor for DSMBs for interim monitoring and analyses. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | Crestovo Phase 2 | Tobira Phase 3 | Lux Biosciences Phase 3 | NIDCD Phonotrauma DSMC | Univ of Pgh School of Dental Med DSMB Mutants Strep | MAPP1 | MAPP2 | Yes | Yes | ||||||
| Christopher | Coffey | University of Iowa | North America (Iowa | christopher-coffey@uiowa.edu | 319-384-4197 | N500 CPHB | 145 N. Riverside Drive | PhD | - Biostatistics - Clinical Trials - Neurology/Neurosurgery | - Cardiovascular Disease - Diabetes - Neurology/Neurosurgery | 20 | Yes ( -Industry -Academia -Government ) | - Statistician | Yes | No | No | |||||||||||||||||||
| Ludovic | Trinquart | Tufts Medical Center | North America (Massachusetts, Eastern Time) | ltrinquart@tuftsmedicalcenter.org | 617-636-8049 | https://www.tuftsctsi.org/people/ludovic-trinquart/ | 35 Kneeland St | Boston MA 02111 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Oncology | - Cardiovascular Disease - Critical Care Medicine - Oncology | https://scholar.google.com/citations?user=N8UACYQAAAAJ&hl=en&oi=ao | I am the Director of the DSMB program and of the Center for Clinical Trials at Tufts CTSI and the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center. | 14 | Yes ( -Academia ) | - Statistician | Yes | Yes | Yes | ||||||||||||||||
| David | Couper | University of North Carolina at Chapel Hill | North America (North Carolina, Eastern Time) | david_couper@unc.edu | (919) 384-5528 | CSCC, Dept. Biostatistics | 123 W. Franklin St.; Suite 450 | Chapel Hill, NC 27516 | PhD | - Biostatistics | https://www.ncbi.nlm.nih.gov/myncbi/david.couper.1/bibliography/public/ | https://sph.unc.edu/wp-content/uploads/sites/112/2021/09/CouperSept2021cv.pdf.pdf | 23 | Data Coordinating Center PI or biostatistician for several clinical trials. | Yes ( -Industry -Government ) | - Statistician | Yes | UNC's TraCS Institute DSMB | NIAMS-sponsored JAK Inhibition in Down Syndrome | NIAMS-sponsored Molecular Transducers of Physical Activity Consortium (MoTrPAC) | NIA-funded Longeveron Protocol No. 01-003 | NIDDK-funded Lifestyle Interventions For Expectant Moms (LIFE-Moms) | NIAMS-sponsored JAK Inhibition in Down Syndrome | No | Yes | ||||||||||
| Chen | Hu | Johns Hopkins University | North America (Maryland, Eastern Time) | huc@jhu.edu | 410-614-3508 | https://www.hopkinsmedicine.org/profiles/details/Chen-Hu | 550 N. Broadway, Suite 1111-B | Baltimore, MD 21205-2013 | PhD | - Biostatistics - Clinical Trials - Oncology - Psychiatry/Behavioral Sciences - Radiology - Respiratory Disease | https://scholar.google.com/citations?user=5kdJ8CUAAAAJ&hl=en | Clinical trial biostatistician with substantial experiences in phase I, II and III oncology clinical trials, sponsored by NCI, industry and others. Lead statistician in NRG Oncology (one of four adult cancer cooperative groups funded by NCI/CTEP). Statistician of 40+ non-randomized and randomized multi-center international trials. Expertise in trial design, monitoring, conduct and analysis. | https://orcid.org/0000-0003-4672-1981 | 15 | Clinical trial biostatistician with substantial experiences in phase I, II and III oncology clinical trials. Statistician of 50+ non-randomized and randomized multi-center international trials. Expertise in trial design, monitoring, conduct and analysis. | Yes ( -Academia ) | - Statistician | No | Yes | No | |||||||||||||||
| Sonia | Jain | University of California, San Diego | North America (California, Pacific Time) | sojain@ucsd.edu | 858 822-2388 | 9500 Gilman Drive, MC 0725 | La Jolla, CA, United States | 92093-0725 | PhD | - Biostatistics - Clinical Trials - Infectious Disease - mHealth/Mobile Devices - Neurology/Neurosurgery - Oncology - Ophthalmology - Pediatrics - Psychiatry/Behavioral Sciences - Respiratory Disease | - Infectious Disease - Oncology - Psychiatry/Behavioral Sciences | https://pubmed.ncbi.nlm.nih.gov/?term=%28sonia+jain%5BAuthor%5D%29+AND+%28california%5BAffiliation%5D%29&sort= | https://profiles.ucsd.edu/sonia.jain | 20 | I have served on several DSMB/DMC committees for both academia and industry clinical trials. I have also served as the Lead Biostatistician and Biostatistics Core Director in HIV/AIDS, traumatic brain injury, PTSD, Kawasaki Disease, sleep, and respiratory diseases. | Yes ( -Industry -Academia ) | - Statistician | No | No | Yes | |||||||||||||||
| Andrew | Althouse | University of Pittsburgh School of Medicine | North America (Pennsylvania, Eastern Time) | ada62@pitt.edu | 484-332-8876 | 2505 Partridge Drive, Pittsburgh, PA, USA | Pittsburgh, PA 15241 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Critical Care Medicine | - Cardiovascular Disease - Critical Care Medicine - Respiratory Disease - Surgery | https://www.ncbi.nlm.nih.gov/myncbi/1Hs-cCDdo9YIwh/bibliography/public/ | Andrew D. Althouse, PhD, joined the University of Pittsburgh's Center for Clinical Trials and Data Coordination (CCDC) in August 2018 with a principal research focus on the design, conduct and analysis of randomized controlled trials (RCT’s). Currently, Dr. Althouse is the lead statistician for ten ongoing RCT’s in various clinical areas including cardiology, critical care medicine and primary care. He has a productive record as a collaborative statistician, with over 150 published manuscripts, and he has been an invited speaker on statistical methods in clinical trials at conferences such as Critical Care Reviews, Transcatheter Cardiovascular Therapeutics, and Cardiovascular Revascularization Therapy meetings. He is currently Statistical Editor for Circulation: Cardiovascular Interventions as well as Deputy Statistical Editor for Journal of Thoracic and Cardiovascular Surgery. He also served as the Vice Chair of the American Heart Association Statistics Task Force, which wrote a set of guidelines for reporting in the AHA journals. He also promotes the role of social media for scientific discussion, tweeting frequently at @ADAlthousePhD. In his spare time, he enjoys lifting weights, cooking great meals, and sampling craft beer. He lives in Upper Saint Clair with his wife and two sons. | 12 | I am an applied biostatistician, with an undergraduate degree in Statistics, a Master’s in Applied Statistics, and a doctoral degree in Epidemiology. As a doctoral student at the University of Pittsburgh, I worked as a statistician in the Data Coordinating Center (DCC) for the Bypass Angioplasty Revascularization 2 Diabetes (BARI 2D) trial, a multicenter international randomized clinical trial with a 2x2 factorial design that enrolled 2,368 participants at 49 sites, following each participant for up to five years. This was an excellent introduction to the design, conduct, and analysis of complex multicenter randomized trials. From 2013-2018, I worked as a collaborative biostatistician at University of Pittsburgh Medical Center - first at Magee Womens Research Institute, then the UPMC Heart and Vascular Institute, before joining the Center for Clinical Trials & Data Coordination (CCDC) in August 2018. I was excited to join the CCDC for the opportunity to focus on the design, conduct, and analysis of randomized controlled trials (RCTs). Overall, I have been the lead statistician and co-author on over 150 original research manuscripts across a variety of clinical specialties. Since joining the CCDC, I have been primary statistician for a number of completed and/or ongoing clinical trials, including: a pilot RCT of cardiac resynchronization therapy in elderly patients, two RCTs testing approaches to palliative care delivery / advance care planning in patients with advanced cancer, a parallel-group RCT of metformin in patients with polycystic kidney disease, a parallel-group RCT of a mobile application to promote self-care in atrial fibrillation, two cluster-randomized trials evaluating different approaches to faculty development in research institutions, a randomized crossover trial for menorrhagia in women with von Willebrand disease, a parallel-group RCT of palliative care in patients with cystic fibrosis, and a cluster-randomized trial of practice-level interventions on opioid prescribing practices. | Yes ( -Industry -Academia ) | - Statistician | Yes | A Randomised Multiple Centre Trial of Conservative versus Liberal Oxygenation Targets in Critically Ill Children | A PHASE I/II RANDOMIZED, DOUBLE-MASKED PLACEBO-CONTROLLED STUDY FOR DETERMINING THE SAFETY OF PROCESSED AMNIOTIC FLUID (PAF) DROPS AFTER PHOTOREFRACTIVE KERATECTOMY (PRK) | A Phase I/II Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the treatment of Lumbosacral Radicular Pain due to Spinal Stenosis: Improving Safety and Outcomes in the Treatment of Pain and Disability Related to Spinal Stenosis | A PHASE I/II RANDOMIZED DOUBLE-BLINDED PLACEBO-CONTROLLED CLINICAL TRIAL TO DETERMINE SAFETY AND FEASIBILITY OF USING AN ACELLULAR STERILE FILTERED AMNIOTIC FLUID AS A TREATMENT FOR COVID-19 PATIENTS. | Yes | Yes | ||||||||||||
| Daniel | Heitjan | Southern Methodist University | North America (Texas, Central Time) | dheitjan@gmail.com | (484) 643-0241 | https://people.smu.edu/dheitjan/ | 6335 W. Northwest Highway | Apartment 711 | Dallas, TX 75225 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Epidemiology - Oncology - Psychiatry/Behavioral Sciences - Surgery | - Cardiovascular Disease - Diabetes - Infectious Disease - Neurology/Neurosurgery - Oncology - Ophthalmology - Pediatrics - Pulmonary Disease | https://scholar.google.com/citations?user=KB7InloAAAAJ&hl=en&oi=ao | Daniel F. Heitjan is Professor and Chair of Statistical Science at SMU and Professor of Population & Data Sciences at UT Southwestern Medical Center. A native of Detroit, he earned a BSc in Mathematics (1981), an MSc in Statistics (1984), and a PhD in Statistics (1985) from the University of Chicago. He served on the faculties of UCLA (1985–1988), Penn State (1988–1995), Columbia University (1995–2002), and the University of Pennsylvania (2002–2014) before moving to Texas in 2014. Dr. Heitjan has over 200 publications in the literature of medicine and statistics, and is an elected Fellow of the American Statistical Association (1997), the Institute of Mathematical Statistics (2012), and the Society for Clinical Trials (2017). His research interests include clinical trial design, causal modeling, the theory of inference with incomplete data, and statistical methods in health economics, pharmacogenomics, and smoking cessation research. | https://people.smu.edu/dheitjan | 30 | I have worked in cancer center biostatistics cores, designing and analyzing cancer trials, for most of my career. I was the principal statistician on REMATCH, a landmark study that was the first randomized trial of an LVAD. In the past 20 years I have served on numerous DSMBs. I am a deputy editor of Clinical Trials and a fellow of the Society for Clinical Trials. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | DMCs i have served on are listed in my CV. | No | Yes | ||||||||||||
| Keith | Sullivan | James B. Wyngaarden Professor of Medicine, Duke University Medical Center | North America (North Carolina, Eastern Time) | keith.sullivan@duke.edu | 919 684 1762 | https://scholars.duke.edu/person/sulli025 | 2400 Pratt St, Suite 5000, Durham, NC 27705 | MD | - Clinical Trials - Other (Stem Cell Transplantation and Cellular Therapy, Scleroderma, Sickle Cell Disease) | - Other (Stem Cell Transplantation and Cellular Therapy, Scleroderma, Sickle Cell Disease) | https://scholar.google.com/citations?user=hgRughcAAAAJ&hl=en | https://scholars.duke.edu/person/sulli025 | https://scholars.duke.edu/person/sulli025 | 45 | Clinical trialist with 45+ years of continuous NIH funding. Electee Association of American Physicians (2001) and Fellow American Association for the Advance of Science (2003). Highly Cited Researcher, Clinical Medicine Category, Institute for Scientific Information (2002). Recipient of the David Sackett Trial of the Year Award, Society of Clinical Trials, 2018. Lifetime Achievement Award, American Society for Transplantation and Cellular Therapy (2020) and electee Fellow ASTCT (2020). | Yes ( -Industry ) | - Medical expert | Yes | Kiadis Pharma, chairman of Independent Data Monitoring Comm, 2011 to present | Kiadis IDMC | No | No | |||||||||||||
| Chaoqun(Charles) | Mei | Bristol Myers Squibb | North America (New Jersey, Eastern Time) | chaoqunmei@gmail.com | (608) 977-3568 | 745 River Rd, Chatham, NJ 07928 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Oncology - Quality Improvement | 6 | No | - Statistician | Yes | Yes | Yes | |||||||||||||||||||||
| Eslam | Maher | Children's Cancer Hospital, Egypt (57357) | Africa | Maher.sci@gmail.com | 01226123007 | 56 Masr_helwan Agricultural St, Al Maadi, Cairo Governorate, Egypt | Master's degree Bachelor's degree | - Biostatistics - Clinical Trials - Epidemiology - Neurology/Neurosurgery - Oncology - Pediatrics | https://scholar.google.com.eg/citations?user=ZbSK3WwAAAAJ&hl=en | https://orcid.org/0000-0001-5428-1555/print | I work in the Clinical Research Department at Children's Cancer Hospital in Egypt, which is a large tertiary center that treats children with cancer for free. I manage a small team, with a background in pharmacy, working specifically on childhood brain tumors (pediatric neuro-oncology). This includes everything related to developing standard protocols, clinical trials, data management, and biostatistics. | https://orcid.org/0000-0001-5428-1555/print | 5 | - Experience in protocol writing for a local phase I trial for 5-aminoleveulinic acid in diffuse intrinsic pontine glioma - Biostiatical analysis (using R and SPSS) for two local physiotherapy trials in brain tumors children with ataxia - Studying MSc Clinical Trials at London School of Hygiene and Tropical Medicine (DL), where I passed the "Data Monitoring and Interim Analysis" module, serving as part of group work as a DMC member in a fictional trial - Day to day monitoring of the international trial Head Start 4 in Medulloblastoma | No | - Statistician | No | Yes | No | ||||||||||||||||
| Joseph | Koopmeiners | Division of Biostatistics, University of Minnesota | North America (Minnesota, Central Time) | koopm007@umn.edu | 612-624-7486 | https://directory.sph.umn.edu/bio/sph-a-z/joseph-koopmeiners | Division of Biostatistics, A460 Mayo Building, MMC 303, 420 Delaware St. SE | A460 Mayo Building, MMC 303 | 420 Delaware St. SE | PhD | - Biostatistics - Clinical Trials | - Cardiovascular Disease - Critical Care Medicine - Pediatrics - Psychiatry/Behavioral Sciences | https://scholar.google.com/citations?user=wFDbJIcAAAAJ&hl=en | A brief bio can be found on my faculty profile: https://directory.sph.umn.edu/bio/sph-biostatistics/joseph-koopmeiners | https://docs.google.com/file/d/0Bz2LYg7VnnqSVFg1SG45SGlLdjA/edit | 12 | I have worked on the following multi-center clinical trials: - CENIC 1 randomized trial of very low nicotine content cigarettes - lead statistician - CENIC 2 randomized trial of very low nicotine content cigarettes in real world settings - Director of Biostatistics and Data Management Core, member of steering committee - PREVAIL randomized trial of treatments for Ebola: unblinded statistician - ALPS COVID randomized trial of losartan for the treatment of COVID-19: co-PI of data coordinating center - ACTIV-3 randomized trial of monoclonal antibodies for the treatment of COVID-19: unblinded statistician | Yes ( -Academia -Non-profit/Co-operative group ) | - Statistician | Yes | SMI Wizard Cluster Randomized Trial | Appy CDS Cluster Randomized Trial | Caring Texts Randomized Controlled Trial | No | Yes | ||||||||||
| Sameer | Parpia | McMaster University | North America (Canada, Eastern Time) | parpia@mcmaster.ca | 905-527-2299 Ext 42685 | https://experts.mcmaster.ca/display/parpia | Juravinksi Hospital & Cancer Centre | 711 Concession St, G Wing - Room 125 | Hamilton, Ontario, Canada, L8V 1C3 | PhD | - Biostatistics - Clinical Trials | - Oncology - Surgery - Other (Venous Thromboembolism) | https://pubmed.ncbi.nlm.nih.gov/?term=%28%28%28Parpia+S%5BAuthor%5D%29+OR+%28Parpia%2C+Sameer%5BAuthor%5D%29%29+NOT+%28Parpia+SS%5BAuthor%5D%29%29+NOT+%28Parpia+SH%5BAuthor%5D%29&sort=date | https://scholar.google.com/citations?hl=en&user=scnP3gMAAAAJ | https://www.zotero.org/parpia/publications | https://sameerparpia.com/ | 15 | I have been involved the the design, conduct, analysis and reporting of clinical trials for 15 years. | Yes ( -Industry -Academia -Non-profit/Co-operative group ) | - Statistician | Yes | Canadian Cancer Clinical Trials Group | COBBRA Trial | STEP-CAT Trial | GeneSight Trials | No | Yes | ||||||||
| Lee | Ellis | The University of Texas MD Anderson Cancer Center | North America (Texas, Central Time) | lellis@mdanderson.org | (713) 859-2329 | 5122 Morningside Drive, Apt. 1009 | Houston, Texas 77005 | MD | - Clinical Trials - Ethics - Oncology | - Oncology | https://scholar.google.com/citations?user=E4OvCdcAAAAJ&hl=en | Trained and practiced in GI surgical oncology until an arm injury ended my active surgery career. Been involved in drug development based on my lab research in GI cancers. Serve the cancer community in many ways: NCI committee, ASCO Board (current), JAMA Oncology Deputy Editor, SWOG Vice Chair, and more. I've served on ECOG DMC for over a decade and serve on several other company DMCs. | Yes ( -Industry -Government ) | - Medical expert | Yes | ECOG | No | Yes | |||||||||||||||||
| Jiwei | Zhao | University of Wisconsin-Madison | North America (Wisconsin, Central Time) | jiwei2012zhao@gmail.com | 608-265-3058 | https://zhaolab.biostat.wisc.edu/ | WARF Office Building | 610 Walnut Street; Room 285 | PhD | - Biostatistics - Clinical Trials - Epidemiology - Health Policy - Infectious Disease | No | - Statistician | No | Yes | No | ||||||||||||||||||||
| Howard | Fingert | National Cancer Advisory Board; guest lecturer MIT Sloan School of Management; Howard Fingert MD Consulting, LLC | North America (Massachusetts, Eastern Time) | hfingert@comcast.net | (617) 610-0535 | 115 WABAN HILL RD NORTH - not Waban Hill Road., Pink house set below street level. Off Manet Street which goes south of Comm Ave near BC. | Pink house set below street level. Off Manet Street which goes south of Comm Ave near BC. | MA 02467 | MD Master's degree | - Clinical Trials - Health Policy - Oncology - Quality Improvement - Other (Hematology; Quality by Design; Clinical Safety Risk Management; Clinical/contextual evaluation of benefit-risk and safety of protocol participants) | http://www.pubmed.gov | Given my prior full-time industry employment, I have not had prior opportunities to serve on a DMC. I am no longer working full-time in Industry, and I would consider it a privilege to contribute to these efforts to expand DMC participation. Over 2 decades, I have had relevant experiences largely in design, conduct, and oversight of phases 1-3 oncology protocols with focus on data integrity, patient safety, and clinical benefit-risk. In academia, I volunteered to be a site auditor for NCI-supported ECOG protocols. More recently I served on the MRCT program to develop harmonized training for clinical research professionals, and the ICHE8 Expert Working Group to update this guidance about US and multi-regional protocol designs. In my Industry roles, I served as the original Pfizer Oncology Therapeutic Area Head, Clinical Safety Risk Management and core member of both Pfizer and Takeda internal Safety Boards, including responsibilities for a) detailed clinical review of data and contextual analyses from internal trials and in-licensing candidates; b) interactions with independent DMCs. Moreover, I have had the privilege to be Industry Representative on the FDA Oncology Drugs Advisory Committee (ODAC), the NCI Clinical Trials and Translational Research Advisory Committee, and the National Cancer Advisory Board. As an aside, I have been repeatedly vetted by the NIH re: financial conflict of interests for my role as a Special Government Employee. I continue to be engaged in training programs relevant to DMC efforts, including volunteer work with Bob O’Neil (former FDA head Biometrics) to organize and deliver courses at MIT Business School for biotech entrepreneurs about protocol designs, conduct, substantial evidence, quality by design, medical benefit-risk analyses along with common pitfalls in trials with modern platforms (e.g. immune-oncology; cell-gene therapy; vaccines) and consideration of mitigation strategies. | 25 | See above summary of over 20 years experience with academic and industry protocols. Given my prior full-time industry employment, I have not had prior opportunities to serve on a DMC. I am no longer working full-time in Industry, and I would consider it a privilege to contribute to these efforts to expand DMC participation. | No | - Medical expert | No | Yes | No | ||||||||||||||||
| Herb | Pang | Genentech | North America (California, Pacific Time) | pathwayrf@gmail.com | (650)5344312 | 1 DNA Way MS 454A | South San Francisco, CA 94080 | PhD Master's degree Bachelor's degree | - Bioinformatics - Biostatistics - Clinical Trials - Epidemiology - Oncology | - Oncology | https://scholar.google.com/citations?user=zbuOc4AAAAAJ&hl=en | https://pubmed.ncbi.nlm.nih.gov/?term=herbert+pang | Herbert (Herb) Pang is an Expert Statistical Scientist at Genentech/Roche. His research interests include real-world evidence for drug development, machine learning, biomarker discovery, -omics data, and the design and analysis of clinical trials. Herb obtained his PhD in Biostatistics from Yale University in 2008 and BA in Mathematics and Computer Science from the University of Oxford in 2002. He was formerly a tenured Associate Professor at the University of Hong Kong where he led a team to do research in biostatistics and bioinformatics. He remains as an Honorary Associate Professor at the University of Hong Kong and is also an adjunct faculty in the Department of Biostatistics and Bioinformatics at Duke University School of Medicine. | 12 | Safety statistician - Phase III trial, Genentech 2020-present School of Public Health, The University of Hong Kong, 2013-2019 Faculty Statistician Duke Cancer Institute Statistical Center, Faculty Statistician 2008-2013 Alliance/CALGB Respiratory Committee – co-lead statistician 2008-2013 Designed, monitored, analyzed over 30 Phase I, II, III clinical trials | Yes ( -Academia ) | - Statistician | No | Alliance/CALGB Respiratory 2009-2013 | Yes | No | ||||||||||||||
| Ting | Ye | University of Washington | North America (Washington, Pacific Time) | tingye1@uw.edu | (608) 960-2980 | https://sites.google.com/view/tingye | 6810 Roosevelt Way NE | Apt 421 | PhD | - Biostatistics - Clinical Trials - Infectious Disease | https://scholar.google.com/citations?user=srCLrrUAAAAJ&hl=en | https://drive.google.com/file/d/1iTlmmvw7pUIr2Zo4sshZbRH2a47MSB_o/view | I have conducted research in clinical trials. Four months before I started getting involved with the HIV Prevention Trials Network. | No | - Statistician | Yes | Yes | No | |||||||||||||||||
| Rameela | Raman | Vanderbilt University School of Medicine | North America (Tennessee, Central Time) | r.raman@vanderbilt.edu | (716) 472-6724 | https://biostat.app.vumc.org/wiki/Main/RameelaChandrasekhar | 1711 Temple Ave | Nashville TN 37215 | PhD Master's degree | - Biostatistics - Clinical Trials - Critical Care Medicine - Epidemiology - Health Policy - Infectious Disease - Psychiatry/Behavioral Sciences - Pulmonary Disease - Respiratory Disease | - Critical Care Medicine - Pulmonary Disease | https://scholar.google.com/citations?user=8Dxl24cAAAAJ&hl=en | https://www.ncbi.nlm.nih.gov/myncbi/rameela.raman.1/bibliography/public/ | I have been leading the statistical core of critical care studies within the Critical Illness, Brain Dysfunction, and Survivorship (CIBS) Center at Vanderbilt since 2013. I have been/am the Co-I for multiple NIH-funded multi-center randomized clinical trials and observational studies. Under my statistical leadership, I have guided our multidisciplinary research team to adopt efficient and modern approaches to study designs and employ rigorous statistical methods. I lead a team of staff biostatisticians and graduate student research assistants and have published over 100 articles in areas of health services and clinical research. My methodological research interest is primarily motivated by challenges encountered in my collaborative work. | https://biostat.app.vumc.org/wiki/Main/RameelaChandrasekhar | 8 | I've been working on randomized clinical trials in critical care for the past 8 years. Some example studies are MIND-USA, MENDS2, SCOPE, COPE-iOS, mini-MENDS, MENDING. I always strive to be involved in these trials starting from the time the idea is conceived all the way till the publication stage. I typically lead a team of staff statisticians and we aim for patient safety, high rigor in the overall conduct of the study including data management, methods, transparency as well as reproducibility. | Yes ( -Academia ) | - Statistician | No | REHAB-PH Study, NHLBI | FREEDOM Study, NIA | Yes | Yes | |||||||||||
| Katherine | Guthrie | Fred Hutchinson Cancer Research Center | North America (Washington, Pacific Time) | kguthrie@fredhutch.org | (206) 667-5595 | 1100 Fairview Ave. N., M3-C102 P.O. Box 19024 | PhD | - Biostatistics - Clinical Trials - Oncology | - Oncology - Other (Rheumatology, Women's health - menopause) | https://www.ncbi.nlm.nih.gov/myncbi/katherine.guthrie.1/bibliography/public/ | I am a Professor of Biostatistics at the Fred Hutchinson Cancer Research Center, specializing in the design and conduct of clinical trials. My goal as a biostatistician is to provide statistical leadership that promotes the integrity and utility of the scientific research in which I am involved. I contribute to the areas of women’s midlife health, gastrointestinal (GI) cancer treatment and cancer survivorship. I serve as the faculty statistician for the NCI-sponsored SWOG Gastrointestinal, Cancer Survivorship, and Palliative and End of Life Care Committees. In these roles, I design, implement, and analyze data from many NCI-supported clinical trials every year. I also collaborate on translational studies that are integrated into those trials and provide expertise as a co-investigator on grants to fund these additional ancillary studies. I currently serve on the NCI GI Steering Committee. I serve as a PI of the Menopause Strategies: Finding Lasting Answers for Symptoms and Health (MsFLASH) research network, which seeks to find new ways to alleviate the most common, bothersome symptoms of the menopausal transition by designing and conducting clinical intervention studies. I lead the MsFLASH Data Coordinating Center and provide scientific leadership to the research network, so far overseeing study design and implementation, database development and data monitoring, statistical analysis and reporting of five multi-center randomized clinical trials and several ancillary studies. | 30 | Yes ( -Industry -Academia -Government ) | - Statistician | Yes | NIH/NIA sponsored study, “Transdermal Nitroglycerin Therapy for Menopausal Hot Flashes” | NIH/NIAMS sponsored study, “Effect of Adrenal and Gonadal Hormones on Bone Marrow and Appendicular Bone Density” | Fred Hutch Nonmyeloablative transplantation protocols | NIH/NIAMS sponsored study, “The Treatment of Methotrexate Resistant Rheumatoid Arthritis with Aminopterin” | Other Fred Hutch/UW protocols | No | Yes | |||||||||||||
| Erin | Jonaitis | University of Wisconsin-Madison School of Medicine & Public Health | North America (Wisconsin, Central Time) | jonaitis@wisc.edu | 608-262-1888 | 600 Highland Drive | PhD Master's degree | - Biostatistics - Psychiatry/Behavioral Sciences - Other (Alzheimer's disease) | - Other (Study statistician at IDMC for ~2 years) | https://pubmed.ncbi.nlm.nih.gov/?term=Jonaitis+EM&cauthor_id=33336877 | I have a PhD in Psychology and a MS in Statistics. I am currently a staff scientist / statistician at the Wisconsin Alzheimer's Institute (UW-Madison), where my work focuses on applied statistical methods for understanding longitudinal data, especially cognitive assessments, and harmonizing cognitive and bioassay measurements across cohorts. Prior to joining WAI, I served as a biostatistician at Frontier Science & Technology Research Foundation, a small nonprofit CRO which provides ISAC services to DMCs. | In the years I spent at an ISAC, I provided statistical support for trials pertaining to multiple sclerosis and hypercholesterolemia. I understand the constraints on the ISAC and the DMC, and what they mean for decision making: the data are interim and therefore messy, and nonparametric tests and data visualization are often the best way to understand what's happening; they are also copious, and a single apparent safety signal p<.05 among hundreds of tests should be interpreted with caution. I have some familiarity with alpha spending / stopping boundaries as well. | No | - Statistician | No | Yes | No | ||||||||||||||||||
| David | Glidden | University of California, San Francisco | North America | david.glidden@ucsf.edu | (415) 846-2581 | http://profiles.ucsf.edu/david.glidden | 596 Dellbrook Avenue | San Francisco, CA 94131 | - Biostatistics | - Critical Care Medicine - Infectious Disease - Nephrology - Respiratory Disease - Virology | https://scholar.google.com/citations?user=emmxou4AAAAJ | I am a collaborative statistician with extensive experience in DSMBs in HIV treatment, HIV preventions and COVID-19 therapeutics | 27 | I have worked at cooperative clinical trials group (AIDS clinical trials group), been the unblinded statistician for a trial leading to an FDA approval and been the blinded statistician for an industry study as well as numerous small academic RCTs. | Yes ( -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | NIH/NIAID Therapeutics and Prevention DSMB (Standing DSMB) | Cystic Fibrosis Foundation (Standing DSMB) | iSpy-2 COVID study | Early COVID-Treatment study (Sponsor: University of Washington) | NIH/NIND Neurological AIDS Research Group (Standing DSMB) | Early COVID-Treatment study (Sponsor: University of Washington) | No | Yes | ||||||||||
| Kent | Koprowicz | Cytel, Inc. | North America (Washington, Pacific Time) | kent.koprowicz@cytel.com | (206) 601-8067 | 2601 4th Avenue | Suite 200 | Seattle, WA 98121 | Master's degree | - Biostatistics | - Cardiovascular Disease - Critical Care Medicine - Diabetes - Immunology - Infectious Disease - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pathology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Radiology - Respiratory Disease - Surgery - Virology | 15 | Yes ( -Industry ) | - Statistician | Yes | No | Yes | ||||||||||||||||||
| Michael | Verret | Chu de Québec - Université Laval | North America (Canada, Eastern Time) | michael.verret.med@ssss.gouv.qc.ca | 418-906-2705 | 28 le gallois, gatineau, québec, J8V2H3 | MD Master's degree | - Epidemiology | No | No | Yes | No | |||||||||||||||||||||||
| Steven | Hawken | Ottawa Hospital Research Institute and University of Ottawa | North America (Canada, Eastern Time) | shawken@ohri.ca | (613) 327-7518 | 208 Poplin Street | Manotick ON | K4M0G9 | PhD Master's degree Bachelor's degree | - Bioinformatics - Biostatistics - Clinical Informatics - Clinical Trials - Epidemiology | - Cardiovascular Disease - Critical Care Medicine | https://www.ncbi.nlm.nih.gov/myncbi/1bWW-W2c80pQz/bibliography/public/ | https://scholar.google.ca/citations?user=aTyysxgAAAAJ&hl=en | http://www.ohri.ca/profile/shawken | http://www.ohri.ca/profile/uploads/shawken/Documents/SHawken%20CV%209NOV2021.pdf | 21 | I have served as responsible statistician on several cardiovascular and critical care trials, where I was responsible for preparing and presenting interim safety, efficacy and recruitment reports to the DSMB. I have also served as DSMB statistician on three DSMB committees. | Yes ( -Academia ) | - Statistician | Yes | Study: Transcatheter Mitral Valve Repair for Inotrope Dependent Cardiogenic Shock – The CAPITAL MINOS Trial Principal Investigator: Dr. Benjamin Hibbert, University of Ottawa Heart Institute | Study: Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion Principal Investigator: Dr. Benjamin Hibbert, University of Ottawa Heart Institute | Study: Comparison of Milrinone versus Dobutamine in a Heterogeneous Population of Critically Ill Patients – The Capital Do-Re-Mi Trial) Principal Investigator: Dr. Benjamin Hibbert, University of Ottawa Heart Institute | Yes | No | ||||||||||
| Ronald | Krall | University of Rochester | North America (Colorado, Mountain Time) | krallrl@gmail.com | 484-744-1575 | PO Box 775727 | Steamboat Springs, CO. 80477 | MD | - Biostatistics - Cardiovascular Disease - Clinical Informatics - Clinical Trials - Epidemiology - Ethics - Neurology/Neurosurgery - Oncology - Psychiatry/Behavioral Sciences - Pulmonary Disease - Respiratory Disease | Former Chief Medical Officer and Head Worldwide Development, GlaxoSmithKline; Head of US Development, AstraZeneca. Currently, External Member Takeda Safety Board. | https://www.dropbox.com/s/48bfd8md7rof2c6/2021.RLK%20CV%20Short%2007Sep21.pdf?dl=0 | 50 | I have conducted and overseen hundreds of clinical trials, from Phase 1 to 4, including outcome studies. | No | - Medical expert - Ethicist | Yes | Yes | No | |||||||||||||||||
| Somar | Alkatreeb | Asia | somar.alkatreeb@gmail.com | 00963951379805 | Rawda Sq. Damascus Syria | Bachelor's degree | - Clinical Trials - Surgery | No | Yes | Yes | No | ||||||||||||||||||||||||
| MANOHARA | HALASIDDAPPA | Algok Bio | North America (California, Pacific Time) | manohar14u@gmail.com | (201) 884-0649 | 10162 PARK CIR W APT 2 | CUPERTINO | CA | Bachelor's degree | - Clinical Trials - Immunology - Infectious Disease - Oncology | With a career spanning more than 15 years, Manohara Halasiddapa is a global clinical development & operations leader for the development of numerous novel therapeutics targeting oncology, immunology, and infectious diseases and has extensive experience in clinical research across the pharmaceutical and CRO industry, spanning the US, Europe, and Asia Manohara is responsible for the end-to-end oversight of clinical development deliverables with expertise in basic and translational science, regulatory requirements, and critical path activities in drug development. He is responsible for leading the strategic execution of Global Clinical Operations, including clinical trial execution, quality oversight, process simplification and optimization, clinical vendor management, and clinical trial financial planning and analysis. Manohara is a member of the Drug Information Association (DIA), Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SOCRA), The Society for Clinical Trials, Institute of Clinical Research (UK), American Association for the Advancement of Science (AAAS) Manohara holds a Bachelor of Dental Surgery (BDS), from Rajiv Gandhi University of Health Sciences (RGUHS), and Post-Graduate Diploma in Clinical Research, Bangalore, Karnataka, India | 15 | ? Pharmaceutical Professional with well-rounded experience (15+ years) at start-up pharmaceutical, Global pharma, and Contract Research Organization (CRO). ? Extensive pharmaceutical drug development experience. Therapeutic area experience in various indications, with particular focus on early development of Oncology drugs in a complex setting. ? Broad drug development experience in leading clinical development from First-In-Human Phase I through Phase IV clinical trials with multiple investigational drug products in various indications Therapeutic Area Experience ? Oncology: Gastric Cancer (GC), Colorectal (CRC), Adenoid Cystic Carcinoma (ACC), Hepatocellular Carcinoma (HCC), Sarcomas, Ovarian Cancer and NSCLC ? Chronic Infectious Disease: Hepatitis C, Hepatitis B ? Immunology: Rheumatoid Arthritis and Psoriatic Arthritis ? Cardiovascular: Myocardial Infarction ? Dermatology: Active Psoriasis, Skin Infections & Skin and structural infections ? Musculoskeletal: Low Back Pain ? Neurology: Post Herpetic Neuralgia | No | - Other (Clinical Trial expertise) | No | Yes | Yes | |||||||||||||||||
| Alexia | Iasonos | Memorial Sloan Kettering Cancer Center | North America (New York, Eastern Time) | iasonosa@mskcc.org | 16462869897 | https://www.mskcc.org/profile/alexia-iasonos | 55 E 87TH ST APT 3H | new york, NY 10128 | PhD | - Biostatistics - Clinical Trials - Oncology | - Oncology - Surgery | https://pubmed.ncbi.nlm.nih.gov/?term=Iasonos%20A | Dr. Iasonos has been at MSKCC since 2005. She has collaborated primarily with investigators studying ovarian cancer and also with investigative teams studying bladder cancer, lymphoma, and health outcomes. Through her collaborations with investigators in gynecology (Departments of Surgery, Medicine and Pathology) she is exploring various biomarkers and assessing relationships to histology, metastasis and clinical outcome. She is also involved in vaccine trials as a second line therapy in ovarian cancer patients, and in identifying valid endpoints for these trials. Her methodological interests focus on model-based designs that guide the dose escalation in phase I trials and in the past few years she has focused on the design of early phase trials that involve dose expansion cohorts. | https://www.mskcc.org/profile/alexia-iasonos | 20 | Lead statistician on 119 investigator initiated protocols since 2005 when I joined Memorial Sloan Kettering. The diseases are urology, lymphoma, and gynecologic cancers and they were initiated from the department of Medicine and Surgery. Most were Phase I or Phase II therapeutic clinical trials. Currently lead statistician on 41 investigator initiated protocols that are open for accrual (which were approved between 2016 -2021). | Yes ( -Industry -Academia -Non-profit/Co-operative group ) | - Statistician | Yes | Yes | No | ||||||||||||||
| DIxie | Ecklund | Universit of Iowa | North America (Iowa, Central Time) | dixie-ecklund@uiowa.edu | (319) 335-8446 | https://ctsdmc.uiowa.edu | Clinical Trials Statistical & Data Management Center | 145 N. Riverside Dr.N500 CPHB | Iowa City, IA 52242 | Master's degree | - Clinical Informatics - Clinical Trials - Ethics - Quality Improvement | https://www.ncbi.nlm.nih.gov/myncbi/dixie.ecklund.1/bibliography/public/ | Dixie J. Ecklund, RN, MSN, MBA is the Director of Operations for the University of Iowa Clinical Trials Statistical & Data Management Center (CTSDMC) which has served as the DCC, the CCC, and/or the Statistical Core for the NIH-funded Clinical Islet Transplantation (CIT) Consortium, the CHAMP study, NeuroNEXT, A2CPS, and FM TIPs as well as the Michael J. Fox-funded PPMI. Ms. Ecklund’s career at the University of Iowa spans over 40 years. She has over 30 years of experience in conducting clinical trials through the CTSDMC and in her previous role as Nurse Manager of the General Clinic Research Center (GCRC). She has been involved in various capacities in hundreds of clinical trials, ranging from small Phase 1 safety studies to large multi-center Phase 3 efficacy studies. She has extensive administrative experience with responsibilities including protocol design, implementation, and compliance, safety management, resource allocation, and collaboration with multiple partners. Ms. Ecklund has served as a member of the Institutional Review Board (IRB) for over 25 years and was appointed an IRB chair in 2009. She established the Central IRB at the University of Iowa for A2CPS and FM TIPS. Ms. Ecklund serves as the liaison for the NeuroNEXT DSMB, the FM TIPS DSMB, and assisted in the design and implementation of the A2CPS Safety Monitoring Committee. Ms. Ecklund has assisted in the preparation of numerous DSMB reports (open and closed) and attended numerous DSMB meetings as a DCC representative. | https:ctsdmc.uiowa.edu | 35 | See bio | Yes ( -Academia -Government ) | - Ethicist - Other (Nursing and Clinical Trial Operations) | No | Yes | Yes | ||||||||||||||
| Stefan | Michiels | Gustave Roussy, INSERM, University Paris-Saclay | Europe | stefan.michiels@gustaveroussy.fr | (014) 211-4144 | http://www.publicationslist.org/stefan.michiels | 114 rue Edouard Vaillant, Gustave Roussy B2M RDC SBE | 94805 Villejuif - France | PhD | - Biostatistics | - Critical Care Medicine - Immunology - Infectious Disease - Neurology/Neurosurgery - Oncology - Pediatrics - Pulmonary Disease - Respiratory Disease | http://www.publicationslist.org/stefan.michiels | tefan Michiels is Head of the Office of Biostatistics and Epidemiology at Gustave Roussy, and Head of Oncostat, CESP, INSERM U1018, University Paris-Saclay in Villejuif, France. His areas of expertise are clinical trials, meta-analyses, biomarkers and clinical prediction models. Stefan is the currently the chair of the biostatisticians at Unicancer, a French collaborative cancer clinical trials group. Stefan holds a PhD in Biostatistics from the School of Public Health at the University Paris-Sud and Master Degrees in Statistics and in Applied Mathematics from the University of Leuven. His previous positions include the Université Libre de Bruxelles- Institut Jules Bordet (Belgium), the National Cancer Institute (France) and the University of Leuven (Belgium). Stefan has edited with Susan Halabi the book “Textbook of Clinical Trials in Oncology – A Statistical Perspective“ and has authored above 200 peer-reviewed publications. He is currently member of the editorial board of Annals of Oncology, NPJ Breast Cancer and Cancer Prevention Research and performs regular statistical reviews for the Lancet family of journals. | 20 | Head of a clinical trials unit with >100 active trials in oncology. | Yes ( -Industry -Academia -Non-profit/Co-operative group ) | - Statistician | Yes | Many academic, biotech and industry trials in different indications. | Several DMCs. | No | No | |||||||||||||
| Maureen | Maguire | JAEB Center for Health Research & University of Pennsylvania | North America (Maryland, Eastern Time) | maguirem@pennmedicine.upenn.edu | 410 435 6274 | https://www.med.upenn.edu/apps/faculty/index.php/g275/p10626 | 5703 Downing Place | Baltimore MD 21212 | PhD | - Biostatistics - Clinical Trials - Epidemiology - Ophthalmology | - Ophthalmology | https://www.ncbi.nlm.nih.gov/myncbi/maureen.maguire.1/bibliography/public/ | Dr. Maguire, Professor Emeritus - University of Pennsylvania, was a member of the Johns Hopkins faculty in the Department of Ophthalmology until she was recruited to lead the Center for Preventive Ophthalmology and Biostatistics at Penn. She is an internationally recognized expert in the design and conduct of multicenter clinical research in ophthalmology and has directed coordinating centers for several national multicenter studies. Although she has conducted research on most major ocular diseases, Dr. Maguire has concentrated her efforts in the prevention and treatment of age-related macular degeneration, the leading cause of blindness in the United States. She initiated and directed for 15 years the Penn Vision Clinician Scientist Program (K12). Dr. Maguire has been the principal investigator for more than 15 grants on the prevention and treatment of ocular disease sponsored by the National Institutes of Health and by industry. She is a Gold Fellow and current President of the Association for Research in Vision and Ophthalmology (ARVO), has received the Achievement Award for distinguished service from the American Academy of Ophthalmology, the Singerman Award for clinical trials from the Macula Society, and the Gass Medal from the Retina Society. She has served as a member of the editorial board of Ophthalmology, JAMA Ophthalmology, IOVS and several other journals. Dr. Maguire chairs data and safety monitoring committees for clinical trials sponsored by NIH and Industry. She has more than 250 peer-reviewed publications in the areas of ophthalmology and clinical research. | https://www.med.upenn.edu/cpob/ | 40 | I have also held leadership positions in approximately a dozen large-scale collaborative clinical research studies on ocular disease and health. I have led, collaborated or consulted on clinical research projects on most of the other major causes of visual impairment including cataract, glaucoma, diabetic retinopathy, inherited retinal degenerations, uveitis, and retinopathy of prematurity. I therefore have a thorough understanding of the types of visual impairment and their impact on quality of life. In addition, I have served on more than 20 data and safety monitoring committees of clinical trials sponsored by the National Institutes of Health (predominantly the National Eye Institute) or industry, and have held the position of chair for 8 of the committees. | Yes ( -Industry -Government -Non-profit/Co-operative group ) | - Statistician - Other (Clinical trialist) | Yes | Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST) | Phase III Clinical Trials of Treatments for Age-related Macular Degeneration and Diabetic Eye Disease | Neuro-Ophthalmology Research Disease Investigation Consortium | Age Related Eye Disease Study II | RPh201 Treatment in Participants with Previous NAION | Adalimumab in Juvenile Idiopathic Arthritis-associated Uveitis Stopping Trial (ADJUST) (National Eye Institute) | Maximizing Trichiasis Surgery Success (MTSS) (National Eye Institute) | Sorafenib in Patients with Hepatopulmonary Syndrome (SHPS) Study (National Heart, Lung, and Blood Institute) | Neuro-Ophthalmology Research Disease Investigation Consortium (National Eye Institute) | Amblyopia and Astigmatism Among Native American Children (National Eye Institute) | No | Yes | ||||
| Barbara S. | Hawkins | The Johns Hopkins University, School of Medicine | North America (Maryland, Eastern Time) | bhawkins@jhmi.edu | 1-410-730-8722 | 9430 Diamondback Drive | Columbia, Maryland, USA 21045 | PhD Master's degree Bachelor's degree | - Biostatistics - Clinical Trials - Epidemiology - Ophthalmology | - Cardiovascular Disease - Oncology - Ophthalmology - Radiology - Surgery - Other (Dental/Maxillofacial) | https://jevons.com | 51 | First exposed to (multicenter, randomized) clinical trials in 1970 as data analyst for the University Group Diabetes Program Coordinating Center with Drs. Klimt, Knatterud, Meinert. Began graduate study in statistics at Johns Hopkins Univ. From 1976-1979, co-investigator with Curt Meinert on NHLBI-sponsored Coordinating Center Models Project. Project manager for the Early Treatment Diabetic Retinopathy Study. In 1981, recruited to Dept. of Ophthalmology at Johns Hopkins to work on field trial in Indonesia. 1982, assumed PI-ship of Macular Photocoagulation Study Coordinating Center. Ex officio member of MPS Data and Safety Monitoring Committee. 1985, served as interim director of the Glaucoma Laser Trial Coordinating Center. 1985, awarded funding to establish the Collaborative Ocular Melanoma Study Coordinating Center. Ex officio member of COMS Data and Safety Monitoring Committee. Established Wilmer Clinical Trials and Biometry as center for design, monitoring, conduct, and analysis of clinical trials. 1997, awarded funding to establish the Submacular Surgery Trials Coordinating Center. | Yes ( -Academia -Government ) | - Other (Epidemiologist, clinical trials methodologist) | No | Choroidal Neovascularization Prevention Trial (Member) | Outcomes Following Myocardial Revascularization. On and Off Pump Cardiopulmonary Bypass (Member) | The Effectiveness of rTMS in Depressed VA Patients (Member) | Diabetes Endothelial Keratoplasty Study (Member) | Others as ex officio member + institutional internal DMCs | Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (Chair) | Oral Cleft Prevention Program: Brazilian Trial of Folic Acid Supplementation to Prevent Cleft Lip and Palate (Chair) | No | Yes | ||||||||||
| David | Musch | University of Michigan, Depts. of Ophthalmology & Visual Sciences and Epidemiology | North America (Michigan, Eastern Time) | dmusch@umich.edu | (734) 763-8175 | Kellogg Eye Center | 1000 Wall Street | Ann Arbor, MI 48109 | PhD Master's degree | - Biostatistics - Clinical Trials - Epidemiology - Ophthalmology | - Neurology/Neurosurgery - Ophthalmology | https://www.ncbi.nlm.nih.gov/myncbi/1z16cnhzGnqQa/bibliography/public/ | Epidemiological research (both observational and interventional designs) on common ophthalmic conditions, with a particular focus on glaucoma treatment, corneal transplantation outcomes, studies of childhood eye disorders. Advisor and consultant to multiple clinical research studies in the Department. Patient-oriented clinical research at the University of Michigan Kellogg Eye Center is thriving and active, with multiple clinical studies in the planning stage, in progress, or nearing completion at any time. In order to yield findings that are scientifically valid, these studies must be based on an appropriate design and rely on valid methods. Dr. David Musch, an epidemiologist, advises both clinicians and basic scientists about constructing research proposals, designing valid studies, and collecting outcome data. Once the data have been gathered, Dr. Musch advises on appropriate analytical methods, interpretation of results, and presentation of findings. His own research addresses measures of treatment efficacy, disparities in eye care, multicenter clinical trial coordination, and variation in measurement and diagnostic abilities. From 1993 to 2004, Dr. Musch directed the Coordinating Center for the NIH-funded Collaborative Initial Glaucoma Treatment Study, and since then has been continuously funded by the National Eye Institute to gain insights from the data gathered on this study’s participants. His multicenter clinical trial involvement and methodological expertise has led to teaching courses on clinical trial principles and methods in the US and internationally. He is a member of the National Eye Institute’s Data and Safety Monitoring Committee for its intramural branch clinical trials, and is currently involved on Data and Safety Monitoring Boards for NIH and company-sponsored clinical trials of treatments for glaucoma, neovascular and geographic forms of age-related macular degeneration, retinal vein occlusion, uveitis, macular telangiectasia type 2, ocular melanoma, thyroid eye disease, and retinitis pigmentosa. | 40 | I served as the Director of the Coordinating Center for a NIH-funded multi-center RCT of glaucoma treatment from 1991 through 2004, wherein I reported to the trial's DSMC. My involvement as a member or chair of monitoring boards for NIH or company-sponsored monitoring committees/boards for RCTs began in the 1990s. I also led an ARVO-sponsored clinical trial education course that included course offering in Mexico, Slovakia, and the United States. In the past ten years, I served on 19 monitoring boards as chair or member for RCTs that have concluded. I currently serve on five DSMCs (two as chair) for NNEI/NIH sponsored RCTs, and nine DSMBs (seven as chair) for RCTs sponsored by companies involved in drug or device development. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | Yes | National Eye Institute intramural branch DSMC; NIH | ADVISE DSMC; National Eye Institute, NIH | Corneal Donor Study DSMC; National Eye Institute, NIH | Leber congenital amaurosis treatment study DSMB; Spark Therapeutics | Independent DMC; AbbVie Inc. | SCORE trial; National Eye Institute, NIH | FLAME trial; National Eye Institute, NIH | Conbercept trial; Kanghong Pharmaceuticals; China | Corneal Preservation Time Study, National Eye Institute, NIH | Hydrus implant Phase 3 trial; Ivantis, Inc., Irvine, CA | No | No | ||||||
| Adriana | Perez | The University of Texas Health Science Center at Houston | North America (Texas, Central Time) | adriana.perez@uth.tmc.edu | (512) 391-2524 | https://sph.uth.edu/cv/perez.pdf | 1616 Guadalupe Street, Suite 6.340 | Austin, TX 78701 | PhD Master's degree Bachelor's degree | - Biostatistics - Cardiovascular Disease - Clinical Trials - Critical Care Medicine - Diabetes - Epidemiology - Infectious Disease - mHealth/Mobile Devices - Pathology - Pediatrics - Pulmonary Disease - Quality Improvement - Respiratory Disease - Surgery | - Other (Cancer) | https://www.ncbi.nlm.nih.gov/myncbi/adriana.perez.3/bibliography/public/ | https://www.ncbi.nlm.nih.gov/myncbi/adriana.perez.3/bibliography/public/ | https://sph.uth.edu/cv/perez.pdf | 18 | Expertise conducting individual and cluster randomized clinical trials and collaborating with clinical investigators worldwide. | No | - Statistician | Yes | Yes | Yes | ||||||||||||||
| Kristina | Foster | University of Kansas Medical Center | North America (Kansas, Central Time) | kfoster6@kumc.edu | 913-588-6393 | https://www.linkedin.com/in/kristina-l-foster-0b6426b/ | The University of Kansas Medical Center | 3901 Rainbow Blvd., Mail Stop 4004 | Kansas City, KS 66160 | Master's degree | - Oncology - Pediatrics | https://www.ncbi.nlm.nih.gov/myncbi/1NQQa6wMuz_ofl/bibliography/public/ | https://www.linkedin.com/in/kristina-l-foster-0b6426b/ | https://www.linkedin.com/in/kristina-l-foster-0b6426b/ | 3 | No | - Patient advocate - Other (Nurse, Coordinator expert) | No | Yes | No | |||||||||||||||
| Virginia | Howard | School of Public Health, Univ of Alabama at Birmingham | North America (Alabama, Central Time) | vjhoward@uab.edu | (205) 934-7197 | RPHB 210F | 1720 2nd Avenue S | Birmingham, AL 35294-0022 | PhD | - Cardiovascular Disease - Clinical Trials - Diabetes - Epidemiology - Neurology/Neurosurgery - Surgery - Other (cognitive function) | - Cardiovascular Disease - mHealth/Mobile Devices - Other (drug abuse) | 30 | Yes ( -Government ) | - Ethicist - Patient advocate - Other (clinical trial methodology, recruitment and retention) | Yes | No | Yes | ||||||||||||||||||
| Gui-shuang | Ying | Center for Preventive Ophthalmology and Biostatistics, University of Pennsylvania | North America (Pennsylvania, Eastern Time) | gsying@pennmedicine.upenn.edu | (267) 808-8867 | 230 Brydon Road | PhD | - Biostatistics - Clinical Trials - Epidemiology - Ophthalmology | - Immunology - Ophthalmology | https://scholar.google.com/citations?user=IUXZXc0AAAAJ&hl=en | Dr. Gui-shuang Ying is Carolyn F. Jones Professor of Ophthalmology and the Director of the Biostatistical Consulting Service in the Center for Preventive Ophthalmology and Biostatistics. Dr. Ying received his MD from P.R. China and Ph.D. in Biostatistics from University of Pennsylvania in 2004. Dr. Ying collaborates with investigators for the study design, statistical analysis and data interpretation and manuscript writing for the multi-center clinical studies. Dr. Ying have served as a senior statistician and, in some cases, the PI, of a large number of NIH-funded clinical studies. In particular, Dr. Ying currently is the PI for the Data Coordinating Center for Fluoreomethlone as Adjunctive Medical Therapy for TT Surgery (FLAME), was the Director of the Data Coordinating Center for the Telemedicine Approaches to Evaluating Acute-phase ROP (e-ROP) study, and the Postnatal growth and retinopathy of prematurity (G-ROP) study, the co-investigator for several NIH-funded multi-center clinical trials or observational studies in Ophthalmology. Dr. Ying was the lead biostatistician for several high impact multi-center clinical trials including the Comparison of AMD Treatment Trials (CATT) and CATT follow-up study, the Dry Eye Assessment and Management (DREAM) Study, the PI for 5 secondary data analysis grants, and co-investigators for a few other studies of glaucoma, cornea and retinal diseases. Dr. Ying has extensive experience in proving biostatistical consulting service to the clinical trial investigators, mostly in vision and ophthalmology community. Dr. Ying’s statistical methodologic research interest is the design of clinical trials, predictions in clinical trials, development of risk prediction models for eye diseases and statistical analysis for correlated data. Dr. Ying has authored and co-authored 350 papers in peer-reviewed journals. | 21 | I have 21 years experience in clinical trials with the role of lead biostatistician or the director of the data coordinating center for several multi-center clinical trials. I serve as a member of DSMC of several clinical trials. | Yes ( -Industry -Academia ) | - Statistician | No | A Phase III, Multi-Center, Randomized, Double-Masked, Sham-Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) | A Phase III, Multi-Center, Randomized, Double-Masked, Sham Controlled Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy with Sham Injections in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD) | A Phase 3, Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Subjects with Geographic Atrophy Secondary to Age-related Macular Degeneration | An Open Label, Non-Randomized, Multi-Center Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in the Treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Double-Masked, Placebo-Controlled Study to Evaluate The Efficacy of Oral AKST4290 In Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI) | No | Yes | ||||||||||||
| Isla | Mackenzie | University of Dundee, Dundee, UK | Europe | i.s.mackenzie@dundee.ac.uk | +441382383119 | MEMO Research | Level 7 Mailbox 2 | Ninewells Hospital and University of Dundee, Dundee, DD1 9SY, UK | PhD Other (MBChB (Honours)) | - Cardiovascular Disease - Clinical Trials | https://discovery.dundee.ac.uk/en/persons/isla-mackenzie/publications/ | Professor of Cardiovascular Medicine at University of Dundee. Completed specialty training in clinical pharmacology and therapeutics and general internal medicine in Cambridge, UK. Experienced chief investigator of clinical trials. Interest in decentralised clinical trials. | 21 | Experience as chief investigator/principal investigator in several multicentre clinical trials - especially in cardiovascular field. Several years of experience as member of trial steering committees. Experience of presenting at and liaising with data monitoring committees as investigator. Keen to now contribute as a member of a data monitoring committee. | No | - Medical expert | Yes | Yes | No | ||||||||||||||||
| Nelson | Kinnersley | Octa Consulting Services Ltd | Europe | nelson.kinnersley@octaconsulting.com | +447733460214 | https://octaconsulting.com | 7 Jameson Road | Harpenden | Herts, AL5 4HG, UK | PhD Master's degree Bachelor's degree | - Biostatistics - Clinical Trials - Oncology | - Oncology | https://scholar.google.com/citations?hl=en&user=FTi1ms0AAAAJ | Nelson has over 30 years of drug development experience where he has used his statistical expertise in global teams developing novel medicines in a range of therapeutic areas. Nelson has been part of global teams working directly in the pharmaceutical industry, developing innovative treatments in oncology/hematology, virology, metabolism and inflammatory diseases. Through this work, he has led the Biostatistics aspects for Regulatory Health Authority submissions and interactions around the world (including FDA, EMA, Swissmedic, Australia TGA and others). He has served on expert review committees providing guidance to teams on strategic drug development. Nelson has also devised and presented multiple training courses on the use and interpretation of medical statistics to experts and non-experts alike. Experience in Independent Data Monitoring Committees from both pharma sponsor side and as statistical member of an iDMC. | 31 | Designing and analysing human clinical trials from Phase 1 to 4 in a wide range of therapeutic areas (see Bio entry) | Yes ( -Industry ) | - Statistician | Yes | Yes | No | ||||||||||||||
| Thomas | Fleming | University of Washington | North America (Washington, Pacific Time) | tfleming@uw.edu | 206-852-1950 | https://www.biostat.washington.edu | 3531 NE 166th Street | Seattle, WA 98155 | PhD | - Biostatistics - Clinical Trials - Ethics | - Cardiovascular Disease - Critical Care Medicine - Diabetes - Immunology - Infectious Disease - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Radiology - Respiratory Disease - Surgery - Virology | https://www.biostat.washington.edu | Thomas R. Fleming, PhD, is Professor and former Chair of the Department of Biostatistics at the University of Washington in Seattle, Member of the Fred Hutchinson Cancer Research Center, and the former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID. Dr. Fleming received his BA in 1972 from the University of St. Thomas and his MA in 1974 and PhD in 1976 from the University of Maryland, College Park. Dr Fleming has authored or coauthored several books and more than 280 research articles in peer-reviewed journals, many regarding the development of state-of-the-art methods for the design, conduct and analysis of clinical trials, and many others reporting the results of landmark trials, including the 2011 publication in NEJM on prevention of transmission of HIV. This research, on which he was senior author, was recognized by Science Magazine to be the scientific “Breakthrough of the Year”. He has chaired or served on Data Monitoring Committees for more than 200 clinical trials. He is a Special Government Employee for the FDA, and for more than 30 years he has served as a regular member of several FDA Advisory Committees and as an invited voting member on more than 100 occasions. Dr Fleming has received numerous awards. He is recipient of the Outstanding Teaching Award, School of Public Health from the University of Washington, and the FDA Commissioner’s Special Citation Award for Extraordinary Contribution to the Agency. He is the 2007 Greenberg Lecturer at University of North Carolina, the 2009 Distinguished Lecturer at the School of Public Health at the University of Washington and, in 2011, the Ross Prentice Endowed Professor of Biostatistical Collaboration. In 2020, he received the Ward Cates Spirit Award from the NIAID HIV Prevention Trials Network. He was elected to membership in the Institute of Medicine of the National Academies in 2012, which became the National Academy of Medicine in 2015. Dr. Fleming is currently a member of the Scientific Steering Committee for the WHO Solidarity COVID-19 Vaccines Trial. | https://www.biostat.washington.edu | 45 | Thomas Fleming is the former Director of the Statistical Center for HIV/AIDS Prevention Trial Network, NIAID. He has authored or coauthored several books and more than 280 research articles in peer-reviewed journals, many regarding the development of state-of-the-art methods for the design, conduct and analysis of clinical trials, and many others reporting the results of landmark trials, including the 2011 publication in NEJM on prevention of transmission of HIV. This research, on which he was senior author, was recognized by Science Magazine to be the scientific “Breakthrough of the Year”. He has chaired or served on Data Monitoring Committees for more than 200 clinical trials. He is a Special Government Employee for the FDA, and for more than 30 years he has served as a regular member of several FDA Advisory Committees and as an invited voting member on more than 100 occasions. He is currently a member of the Scientific Steering Committee for the WHO Solidarity COVID-19 Vaccines Trial. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | No | Yes | ||||||||||||||
| Simon | Bacon | Concordia University & CIUSSS-NIM | North America (Canada, Eastern Time) | simon.bacon@concordia.ca | (514) 848-2424 | https://www.mbmc-cmcm.ca | 7141, Sherbrooke St West, SP165.35 | PhD | - Clinical Trials - mHealth/Mobile Devices - Psychiatry/Behavioral Sciences | - Cardiovascular Disease - Psychiatry/Behavioral Sciences | https://scholar.google.ca/citations?user=6UNs1lwAAAAJ&hl=en | https://www.concordia.ca/artsci/health-kinesiology-physiology/faculty.html?fpid=simon-bacon | https://www.concordia.ca/etc/designs/concordia/resources/file.pdf?did=4504 | 21 | Involved in development and delivery of trials around behaviours, behaviour change, and stress management across multiple diseases. I have a CIHR-SPOR Mentoring Chair in Patient-Oriented, Innovative, Clinical Behavioural Trials. | Yes ( -Academia ) | - Medical expert | No | Ottawa Heart Institute, High Intensity Interval Training for Atrial Fibrillation trial | Yes | No | ||||||||||||||
| Hayley | Belli | New York University Grossman School of Medicine | North America (New York, Eastern Time) | hayley.belli@nyulangone.org | (541) 207-6726 | https://med.nyu.edu/faculty/hayley-belli | 180 Madison, 2nd Floor, 223, New York, NY 10016 | PhD Master's degree Bachelor's degree | - Biostatistics - Clinical Trials - Diabetes - mHealth/Mobile Devices - Psychiatry/Behavioral Sciences | https://scholar.google.com/citations?user=kr2wUIgAAAAJ&hl=en | https://med.nyu.edu/faculty/hayley-belli | 5 | PI of NIH/NIA K01 award leading a clinical trial; co-investigator/lead biostatistician on 14 funded NIH R01 proposals, many of which are clinical trials | Yes ( -Academia ) | - Statistician | Yes | Yes | No | |||||||||||||||||
| Nicholas | Pajewski | Wake Forest School of Medicine | North America (North Carolina, Eastern Time) | npajewsk@wakehealth.edu | (336) 713-1396 | https://school.wakehealth.edu/Faculty/P/Nicholas-M-Pajewski | Medical Center Boulevard | Winston-Salem, NC 27154 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Informatics - Clinical Trials - Neurology/Neurosurgery | - Cardiovascular Disease - Diabetes - Neurology/Neurosurgery - Other (Critical Care) | https://www.ncbi.nlm.nih.gov/myncbi/nicholas.pajewski.1/bibliography/public/ | Nicholas (Nick) Pajewski, PhD, is an Associate Professor in the Department of Biostatistics and Data Science at Wake Forest School of Medicine, where he is also the director of statistical analytics for the Center for Health Care Innovation. Dr. Pajewski is a biostatistician and clinical trialist with experience in large, multi-site randomized trials, largely focused on pharmacologic management of common chronic diseases in older adults. He was the primary faculty biostatistician for the Systolic Blood Pressure Intervention Trial’s cognitive component (SPRINT MIND), is currently a member of the Data Coordinating Center (DCC) and Steering Committee for the PRagmatic EValuation of evENTs And Benefits of Lipid-lowering in oldEr adults (PREVENTABLE) trial, and is PI of the DCC for the Long term Effectiveness of the Antiobesity Medication Phentermine (LEAP) trial. Dr. Pajewski’s research also centers around leveraging the Electronic Health Record for health services research and population health, with a particular focus on applications of the deficit accumulation model of frailty. | 12 | Yes ( -Government ) | - Statistician | Yes | NCT02570672 | NCT04495946 | NCT04798469 | Low Cost Detection of Cognitive Decline (RFA-AG-20-051) and Current Topics in Alzheimer’s Disease and Its Related Dementias (PAR-19-070) | No | Yes | ||||||||||||
| Jessica | Overbey | Icahn School of Medicine at Mount Sinai | North America (North Carolina, Eastern Time) | jessica.overbey@mountsinai.org | (212) 659-9191 | One Gustave L. Levy Place | Box 1077 | Other doctoral degree | - Biostatistics - Cardiovascular Disease - Clinical Trials - Neurology/Neurosurgery - Surgery | - Cardiovascular Disease | https://www.ncbi.nlm.nih.gov/myncbi/14IrpsmVXSqws7/bibliography/public/ | https://www.mountsinai.org/profiles/jessica-r-overbey | 10 | Yes ( -Industry -Academia ) | - Statistician | Yes | Yes | Yes | |||||||||||||||||
| Matt | Downs | North America (Virginia, Eastern Time) | matdowns@gmail.com | (703) 307-6335 | https://www.linkedin.com/in/matt-downs-b0854b4/ | 326 N Patrick St | Alexandria VA 22314 | Master's degree | - Biostatistics | - Cardiovascular Disease - Diabetes - Immunology - Infectious Disease - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pulmonary Disease - Respiratory Disease - Surgery - Virology | https://scholar.google.com/citations?user=a9pRYLkAAAAJ&hl=en | https://www.linkedin.com/in/matt-downs-b0854b4/ | 26 | Yes ( -Industry -Government -Non-profit/Co-operative group ) | - Statistician | No | Yes | Yes | |||||||||||||||||
| Lee | McDaniel | LSU Health Sciences Center | North America (Louisiana, Central Time) | lmcda4@lsuhsc.edu | 504-327-9431 | 1500 Colony Place | Metairie, LA 70003 | PhD | - Biostatistics - Clinical Trials | - Nephrology - Respiratory Disease | 8 | Yes ( -Academia -Government ) | - Statistician | No | Randomized Multicentre Comparative Trial to Evaluate the Long Term Effectiveness of the use of Carbaglu in Patients with Propionic Acidemia or Methylmalonic Acidemia | A Trial of Favipiravir and Hydroxychloroquine combination in Adults Hospitalized with moderate and severe Covid-19 | A Trial of Favipiravir therapy in Adults with mild Coronavirus Disease COVID-19 | Avi-Mild Trial | Evaluation of a Novel Communication Tool for Patients with End-Stage Renal Disease | Yes | No | ||||||||||||||
| Menggang | Yu | University of Wisconsin | North America (Wisconsin, Central Time) | meyu@biostat.wisc.edu | 608-261-1988 | https://sites.google.com/a/wisc.edu/menggang/ | 207C WARF Office Building | 610 Walnut Street | PhD | - Bioinformatics - Biostatistics - Clinical Trials - Diabetes - Epidemiology - Health Policy - Oncology | - Infectious Disease - Oncology - Pulmonary Disease | https://www.ncbi.nlm.nih.gov/myncbi/menggang.yu.2/bibliography/public/ | https://drive.google.com/file/d/1dxMBrMTKQ3HOzA_4IV8SVZRSMkdtqMj-/view | 20 | I have served as main statistician for over 50 clinical trials, most of them are oncology related. I have also served as DSMB members for many trials in the area of oncology, pulmonary drug, quality of life, and infectious disease. | Yes ( -Industry -Academia -Non-profit/Co-operative group ) | - Statistician | No | DMC for a Big Ten Cancer Consortium precision tumor board Breast cancer trial | DMC for a Big Ten Cancer Consortium gastrointestinal cancer trial | DMC for MERCK 027 | DMC for MERCK 042 | DMC for a Neurofibromatosis (NF) Consortium pediatric trial | No | No | ||||||||||
| John | VanBuren | University of Utah | North America (Utah, Mountain Time) | john.vanburen@hsc.utah.edu | (801)-581-6410 | 295 Chipeta Way | Salt Lake City, UT 84108 | PhD | - Biostatistics - Clinical Trials - Other (Bayesian adaptive designs) | https://www.ncbi.nlm.nih.gov/myncbi/john.vanburen.1/bibliography/public/ | https://medicine.utah.edu/faculty/mddetail.php?facultyID=u6007660 | https://medicine.utah.edu/faculty/mddetail.php?facultyID=u6007660 | 6 | I have served as a Data Coordinating Center Principal Investigator or lead faculty on 10 randomized controlled trials. This included 6 NIH funded, 1 other government funded, and 3 industry funded. My areas of specialty is designing and implementing Bayesian adaptive trials. | Yes ( -Government ) | - Statistician | Yes | Fluoroscopic versus Ultrasound Guidance for Cooled Radiofrequency Ablation of Geniculate Nerves in Knee Osteoarthritis: a Randomized Control Trial | Firearm Injury and Mortality Prevention Research PARs (PAR-21-191 and PAR-21-192) | Yes | No | ||||||||||||||
| Alexis | Rompre-Brodeur | National Cancer Institutes | North America (Maryland, Eastern Time) | alexis.r.brodeur@gmail.com | (202) 329-3158 | 5405 Tuckerman Ln | Apt 818 | MD Other (MHS candidate) | - Oncology - Surgery | https://pubmed.ncbi.nlm.nih.gov/?term=alexis+rompre-brodeur | BSc. Honors in Biochemistry 2008-11 - Universite de Montreal, Canada Medical Doctor 2011-15 - Universite de Montreal, Canada Urology Residency 2015-20 - McGill University, Canada Urologic Oncology SUO Fellowship 2020-22 - National Cancer Institute of the National Institutes of Health, USA Masters in Health Sciences (Candidate) 2020 - Duke University, USA | https://drive.google.com/file/d/1ce8m4brwLLB5Qb_WrLyUhfBA00-P5ALi/view?usp=sharing | 7 | I have participated to the elaboration and revision of several (7) phase 2 and 3 clinical trials. | No | - Medical expert | No | Yes | No | ||||||||||||||||
| Giorgio | Paulon | Berry Consultants, LLC | North America (Texas, Central Time) | giorgio@berryconsultants.net | (512) 658-6846 | https://giorgiopaulon.github.io/ | 3625 S 1St St | Apt 121 | PhD Master's degree Bachelor's degree | - Biostatistics - Clinical Trials | https://scholar.google.com/citations?user=j-caV3AAAAAJ&hl=en&oi=ao | Giorgio Paulon is a Statistical Scientist at Berry Consultants. He earned his PhD in Statistics from the University of Texas at Austin in 2021. His research focused on Bayesian clustering methods for longitudinal data. During his doctoral studies, he collaborated on multiple research projects focusing on auditory behavioral neuroscience experiments. Prior to his time at the University of Texas at Austin, he completed a double degree program in Mathematical Engineering between Politecnico di Milano, Italy, and École Centrale Paris, France. | https://giorgiopaulon.github.io/files/Paulon_CV.pdf | 1 | I am a frequent member of Statistical Analysis Committees (SAC), i.e., I present adaptive trial results to DSMBs in closed sessions. My expertise is in Bayesian adaptive clinical trials, | No | - Statistician | No | Yes | No | |||||||||||||||
| Lauren | Gonsalves | North America (Washington, Pacific Time) | lgonsa@uw.edu | (847) 899-9828 | https://www.linkedin.com/in/lauren-gonsalves | 423 Martin Luther King Jr. Way S | Unit A | Bachelor's degree Other (Currently a PhD Candidate) | - Infectious Disease - Pulmonary Disease | - Other (Have not served on a DMC) | https://www.ncbi.nlm.nih.gov/myncbi/lauren.gonsalves.1/bibliography/public/ | Lauren received her B.S. in Genetics, Cell Biology and Development from the University of Minnesota in 2017; Her research during her undergraduate career focused on using QTL mapping analysis to determine the location of genes that affected Arabidopsis thaliana effector-triggered immunity against Pseudomonas syringae in the lab of Fumiaki Katagiri, Ph.D. Following graduation, she went on to work as a research assistant at the U.S. Food and Drug Administration's Center for Food Safety and Applied Nutrition. Her research included studies on the survival of food-borne pathogens in low-moisture foods (seeds, nuts, spices, and flours), ready-to-eat dips, and raw-milk Gouda cheese, and the effect of pH on food-borne pathogen survival in low-moisture environments. In 2018, Lauren began her graduate career--she is currently a Ph.D. candidate in the Department of Microbiology at the University of Washington, in the lab of Lucas Hoffman, M.D, Ph.D. Her current work is centered on how antibiotic and nutritional pressures might impact Staphylococcus aureus metabolism, adaptation, and survival during chronic infection in people with CF. | 1 | I have didactic experience with clinical trials and design--I have taken courses on designing medical studies and I am currently apart of a translational research training program (UW ITHS TL1 Training Program) that provides experience and training in most of the Clinical and Translational Science Awards-designed core competencies in translational research. While my thesis lab is considered translation, and I do have exposure through members in my lab to large clinical studies (largely observational studies), my hands-on, real world-experience with clinical trials is limited. | No | - Medical expert | No | Yes | No | ||||||||||||||||
| Amber | Salter | UT Southwestern Medical Center | North America (Texas, Central Time) | amber.salter@utsouthwestern.edu | (214) 645-6971 | 5323 Harry Hines Blvd | Mail Stop 8806 | Dallas, TX 75390-8806 | PhD Master's degree | - Biostatistics - Clinical Trials | - Neurology/Neurosurgery - Oncology | https://www.ncbi.nlm.nih.gov/myncbi/amber.salter.1/bibliography/public/ | https://profiles.utsouthwestern.edu/profile/80475/amber-salter.html?_ga=2.249673155.439731221.1654532973-90263287.1636401617& | 7 | I coordinate the data collection for clinical trials and prospective longitudinal observational research, including preparing DMC reports for trials. I have prepared statistical analysis plans for clinical trials and analyzed clinic trial data. | Yes ( -Industry -Academia -Government ) | - Statistician | No | Yes | Yes | |||||||||||||||
| Arun | Chind | Proshen Health & Risk Consulting Ltd | Europe | arunpeter@yahoo.com | 07935352290 | https://www.linkedin.com/in/dr-arun-chind-8549a2139/ | 87 Dacre Avenue | Wakefield WF2 8AH, England, United Kingdom | MD Master's degree Other (MBBS, MPH, Certificate in Pharmaceutical Medicine, Graduate Statistician) | - Biostatistics - Cardiovascular Disease - Clinical Trials - Diabetes - Epidemiology - Nephrology - Oncology - Psychiatry/Behavioral Sciences - Pulmonary Disease - Surgery | https://orcid.org/ 0000-0002-3433-6237 | I have been engaged in clinical data analysis for over 20 years. I have been accredited as a Graduate Statistician by the Royal Statistical Society in June 2022. I have been a clinician in several therapy areas including acute/internal medicine, medical and radiation oncology, intensive care and surgical specialties. I have worked in Phase II and III clinical trials as Clinical Research Physician for about 3 months and decided that working on the front line was not for me. I attended DMC training with the PSI (www.psiweb.org) last year. I am hoping to gain experience in DMCs with the SCT. Given my uncommon assortment of clinical training and statistical skills, I expect to make a positive contribution to DMCs. | https://www.linkedin.com/in/dr-arun-chind-8549a2139/ | 1 | I have worked in Phase II and III clinical trials as Clinical Research Physician for about 3 months and decided that working on the front line was not for me. | No | - Medical expert - Statistician | No | Yes | No | |||||||||||||||
| James | Dziura | Yale | North America (Connecticut, Eastern Time) | james.dziura@yale.edu | 203-737-4468 | https://ysph.yale.edu/ycas/ | Suite 511 | 300 George St | New Haven, CT 06519 | PhD | - Biostatistics - Clinical Trials - Critical Care Medicine - Diabetes - Epidemiology - Infectious Disease - mHealth/Mobile Devices - Pediatrics - Psychiatry/Behavioral Sciences | - Cardiovascular Disease - Critical Care Medicine - Diabetes - Immunology - Infectious Disease - mHealth/Mobile Devices - Pediatrics - Psychiatry/Behavioral Sciences - Surgery | https://www.ncbi.nlm.nih.gov/myncbi/james.dziura.1/bibliography/public/ | https://ysph.yale.edu/ycas/dcc/people/ | 20 | I have over 20 years of experience working in clinical trials across all phases and many clinical areas. I'm the co-director of the Yale Data Coordinating Center which provides statistical and data coordination for multicenter trials. I am currently the Co-chair of the Biostatistics Workgroup for the Pain Management Collaboratory (PMC3). I am the Director of the Data Coordinating Center for the Autism Biomarkers Consortium for Clinical Trials (ABC-CT), a multicenter longitudinal study developing reproducible experimental biomarkers (e.g. from EEG, eye tracking) for use as stratification factors and outcomes in clinical trials. I oversee the Data Coordinating Center for the EMBED trial, a large pragmatic trial evaluating the use of clinical decision support to initiate buprenorphine in the ED for opioid use disorder. I’m the senior biostatistician for a large pragmatic trial evaluating community vs health system based care for dementia. I was also a senior biostatistician for STRIDE, a large pragmatic trial investigating a multicomponent intervention for falls prevention. I also served as the PI of the data coordinating center for the RUPP Autism Network study of Guanfacine for the treatment of hyperactivity.As a lead project statistician, I have designed, conducted and analyzed several clinical trials including multicenter trials evaluating Teplizumab to prevent loss of insulin secretion in Type 1 Diabetes (conducted under an IND), comparing laminectomy plus fusion to laminectomy only for lumbar spondylolisthesis, and a trial conducted in the Emergency Department to evaluate wait-and-see prescription for the treatment of acute otitis media. For many of these projects I have prepared and presented open and closed session reports for DSMBs. | Yes ( -Industry -Academia ) | - Statistician | Yes | NIA DAIDS Therapeutics Central DSMB | NICDR Endocrine and Metabolic Bone Disorders | STEP-HI Trial | Clevidipine in Cardiac Surgery, The Medicines Company | Technosphere insulin for the treatment of diabetes, MannKind Pharmaceuticals | NIDCR Endocrine and Metabolic Bone Disorders | A Phase I Safety Trial of CD4+CD127lo/-CD25+ Polyclonal Treg Adoptive Immunotherapy for the Treatment of Type 1 Diabetes | No | Yes | |||||||
| Farah | Khandwala | Berry Consultants | North America (Canada, Mountain Time) | farah@berryconsultants.net | (403) 804-0861 | Master's degree | - Biostatistics - Clinical Trials | Farah Khandwala is a Statistical Scientist for Berry Consultants. She earned her M.S. in Statistics (2001) from Simon Fraser University with a focus on statistical computing and Bayesian methods. She began her career at the Department of Quantitative Health Sciences, Cleveland Clinic Foundation where she collaborated with investigators from various therapeutic areas, primarily gastroenterology and cardiothoracic surgery. She joined the Department of Cancer Epidemiology and Prevention, Alberta Health Services in 2011 where she was contributed to the design and analysis of numerous studies on disease prevalence including the ComPARe study, a national program researching the current and future burden of cancer due to modifiable risk factors. Prior to joining Berry, she worked in the CRO industry as a Senior Biostatistician, leading CDISC compliant trials of all phases, programming analyses and summaries for case study reports, and preparing submission package documentation. | 5 | I have experience serving as lead biostatistician on many academic and industry protocols in a variety of therapeutic areas with responsibilities including SAP development, data management, analysis, and submission materials. I am currently a member of several Statistical Analysis Committees (SAC) producing and presenting interim analysis reports to DSMBs in closed sessions. | No | - Statistician | No | Yes | No | ||||||||||||||||||||
| Tatyana | Der | Duke | North America (North Carolina, Eastern Time) | tatyana.der@duke.edu | 276-791-2272 | https://scholars.duke.edu/person/tatyana.der | 204 Parkmeadow Drive | Cary, NC 27519 | MD Master's degree | - Other (internal medicine/hospitalist ) | - Other (no experience on serving on DMCs) | https://scholars.duke.edu/person/tatyana.der | https://scholars.duke.edu/person/tatyana.der | has served as dub-investigator for activ-1, activ-3, activ-4a and 4c, DOTS trials, current sub-I for STRIVE platform | No | No | Yes | No | |||||||||||||||||
| Ala | Elhelali | Johns Hopkins University | North America (Maryland, Eastern Time) | aelhela1@jhmi.edu | (443) 220-2537 | Suite 8161, Johns Hopkins Outpatient Center | 601 N Caroline Street | PhD Master's degree Bachelor's degree | - Cardiovascular Disease - Clinical Trials - Neurology/Neurosurgery - Surgery | https://scholar.google.com/citations?user=f3YVav4AAAAJ&hl=en | 6 | No | - Ethicist - Other (Methodologist) | No | Yes | Yes | |||||||||||||||||||
| Biyue | Dai | University of Minnesota | North America (Minnesota, Central Time) | biydai@umn.edu | +1 612-626-9108 | https://directory.sph.umn.edu/bio/sph-a-z/biyue-dai | 2221 University Ave SE. | Suite 200 | PhD | - Biostatistics - Clinical Trials - Diabetes - Infectious Disease - Neurology/Neurosurgery - Pediatrics | - Respiratory Disease | https://scholar.google.com/citations?user=HntSHaYAAAAJ&hl=en&oi=ao | https://drupalish.ahc.umn.edu/bios/show-file.php?x500=biydai | 3 | Yes ( -Academia ) | - Statistician | No | Yes | No | ||||||||||||||||
| Ying | Chen | Stanford University/VA | North America (California, Pacific Time) | yqchensu@stanford.edu | (650) 497-8273 | https://profiles.stanford.edu/ying-qing-chen | 3180 Porter Dr | Stanford, CA 94305 | PhD | - Biostatistics - Clinical Trials - Epidemiology - Infectious Disease | - Cardiovascular Disease - Diabetes - Immunology - Infectious Disease - mHealth/Mobile Devices | 25 | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | Yes | Yes | ||||||||||||||||||
| Christina | Saunders | Berry Consultants | North America (Texas, Central Time) | christina@berryconsultants.net | (713) 825-8211 | 3345 Bee Caves Rd | Suite 201 | Austin, TX 78746 | PhD | - Biostatistics | 3 | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | Yes | No | |||||||||||||||||||
| Jan | Tijssen | Amsterdam UMC, Department of Cardiology | Europe | tijssenj@outlook.com | +31 6 1004 1295 | https://www.amsterdamumc.nl | Jan Steenlaan 41; 1412 JT Naarden; The Netherlands | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Diabetes - Epidemiology - Nephrology | - Cardiovascular Disease - Diabetes - Infectious Disease - Oncology - Surgery | https://scholar.google.com/citations?hl=en&user=1nFmckEAAAAJ | Jan G. P. Tijssen, PhD is Emeritus Professor of Clinical Epidemiology and Biostatistics at Amsterdam UMC - University Of Amsterdam. He received his training in Epidemiology and Biostatistics at the Department of Biostatistics at Leiden University and the Clinical Epidemiology Unit of The Thoraxcenter at Erasmus University Rotterdam, where he, in 1987, obtained his Ph.D. cum laude on a thesis entitled ‘Nifedipine and metoprolol in suspected unstable angina'. From 1990 untill 1998, he was Head of the Department of Clinical Epidemiology and Biostatistics at the Academic Medical Center - University of Amsterdam. In 1999 he switched to the Clinical Research Group at the Department of Cardiology. His interests are in study design and data-analysis of clinical research with a special focus on Cardiology and Vascular Medicine. His biostatistical interest is in interim analyses in randomized clinical trials. He is a registered Epidemiologist at the Dutch Epidemiological Society. He is a Fellow of the European Society of Cardiology. He is a recipient of the Sael van Zwanenberg price for Clinical Pharmacologic Research (1980). For many years he has taught Courses on Clinical Trial Methodology and Data Analysis at the Erasmus Summer Programme. He is the author or co-author of over 700 papers. He has been the co-supervisor of more than 40 Ph.D. theses. He is an advisor to the European Cardiovascular Research Institute. He is statistical editor of the Journal of the American College of Cardiology. He has served on more than 50 Data and Safety Monitoring Boards. | https://www.dropbox.com/s/2oe519i5kv2n7qm/Resume-JGPTijssen-221213-SHARED.pdf?dl=0 | 30 | As senior bostatistician, I have authored 12 publications of RCTs in the New England Journal of Medicine. I have served on more that 50 Data Monitoring Committees of large and smaller trials, primarily in cardiovascular medicine. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | EXCEL / N Engl J Med 2016; 375: 2223-35 & N Engl J Med 2019;381:1820-30. | CHAMPION-PHOENIX / N Engl J Med 2013; 368:1303-1313 | Carolina & Carmelina / JAMA. 2019;322(12):1155-1166 &JAMA. 2019;321(1):69-79 | Global Leaders / Lancet. 2010; 375: 283-293 | ReDual trial / N Engl J Med 2017;377:1513-24. | No | Yes | ||||||||||
| Danamarie | Belpulsi, MD | North America (New York, Eastern Time) | DanamarieBelpulsiMD@gmail.com | 212-229-7624 | NA | MD | - Cardiovascular Disease - Clinical Trials - Neurology/Neurosurgery - Ophthalmology - Surgery | - Cardiovascular Disease - Neurology/Neurosurgery - Ophthalmology - Surgery | 13 | A medical investigator with more than 13 years of clinical research experience in both academia and industry, developing and managing multiple phases of clinical trials, both drug and device driven, from concept thru close out. A poised communicator and educator with an ability to build strong relationships with academic clinical research colleagues, who is committed to advancing patient care and the science of medicine thru active engagement and meaningful dialogue with medical and scientific professionals. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert | Yes | confidentiality | 0 chaired | Yes | Yes | ||||||||||||||||||
| April | MacKinnon | Milliken Associates, Inc. | North America (California, Pacific Time) | maincajm@san.rr.com | (858) 229-7170 | https://millikenassociates.com/ | 8537 Celtic Court | San Diego, CA 92129 | Master's degree | - Biostatistics | - Neurology/Neurosurgery | https://millikenassociates.com/team/april-milliken-mackinnon-m-s/ | 10 | Have been a consulting statistician in the animal health industry for almost 30 years. Mixed within, I have worked with various human pharmaceutical companies. I am currently on the DSMB for a medical device company. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | Embolization Device Feasibility Study for a medical device manufacturer | No | No | |||||||||||||||
| Ravi | Shah | Columbia University | North America (New York, Eastern Time) | ravi.shah@columbia.edu | (201) 936-9958 | 939 Myrtle Avenue | MD | - Cardiovascular Disease - Quality Improvement | I am a general cardiology fellow at New York Medical College, and will graduate in June 2023. I will then go onto an Advanced Heart Failure and Transplant fellowship at Columbia University, beginning July 2023. I am board-certified in Internal Medicine, echocardiography, and nuclear cardiology. I am a previous NIH T35 grant recipient. | https://drive.google.com/file/d/1XwdgcZTUthjV5C73QjR_I0-21iXavMfy/view?usp=drivesdk | 9 | Have served as site sub-investigator and site lead for the ACTIV-4 (NIH sponsored) trial, site sub-investigator for MINT trial, site sub-investigator for AEGIS-II trial | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert | Yes | Yes | No | ||||||||||||||||||
| Sven | Trelle | University of Bern, CTU Bern | Europe | sven.trelle@unibe.ch | +41316843372 | https://www.ctu.unibe.ch/about_us/staff/trelle_sven/index_eng.html | Mittelstrasse 43 | CH-3012 Bern | Switzerland | MD Master's degree Other (Habilitation) | - Biostatistics - Clinical Trials | - Immunology - Infectious Disease - Neurology/Neurosurgery | https://orcid.org/0000-0002-8162-8910 | Sven Trelle studied medicine in Hamburg, Germany and has a second master’s degree in medical statistics from the University of Leicester, UK. He coordinated a clinical research team at the hemato-oncology department of the University Hospital Cologne, Germany and was part of the Editorial Base of the Cochrane Hematological Malignancies Group. In 2005, he joined the Institute of Social and Preventive Medicine of the University of Bern as research fellow to conduct methodological research in the field of clinical epidemiology. He is affiliated with CTU Bern since 2008 and functions as its director since 2014. His main focus is on strategically leading the unit, supervising CTU staff, and consulting on clinical research projects – mainly clinical trials. Over the lifetime of his career, he has provided consultancy for more than 500 clinical research projects and peer reviewed more than 200 clinical trial grant applications for various funding bodies. He is regularly teaching on various aspects of clinical research from regulatory aspects over clinical research methodology to implementation and practical issues of conducting clinical research. | https://orcid.org/0000-0002-8162-8910 | 20 | Started career as clinical investigator Did research on clinical trial methodology and meta-epidemiological topics Since 15 years working at an academic clinical trials unit, since nearly 10 years as director. Consulting on clinical trials (primarily randomized trials and some experience in phase II trials) and peer reviewing grant proposals. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | Several DMCs from Roche Pharma | Several DMCs from WHO | None chaired | No | No | ||||||||||
| SUSAN | HALABI | Duke University | North America (North Carolina, Eastern Time) | susan.halabi@duke.edu | (919) 681-5430 | 2424 Erwin Road | Suite 11088 | Durham, NC 27705 | PhD | - Bioinformatics - Biostatistics - Clinical Trials - Oncology | - Cardiovascular Disease - Immunology - Oncology | https://www.ncbi.nlm.nih.gov/myncbi/susan.halabi.1/bibliography/public/ | https://biostat.duke.edu/profile/susan-halabi | 25 | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | TROPIC | ARMOR3 | PRONOUNCE | AFFINITY | BAY 1163877 | Proselica | FirstAna | No | Yes | |||||||||
| Yeonhee | Park | University of Wisconsin | North America (Wisconsin, Central Time) | ypark56@wisc.edu | (352) 278-3066 | https://sites.google.com/view/yeonheepark/home | 207B WARF 610 walnut street, madison, WI 53726 | PhD | - Biostatistics - Clinical Trials | https://www.ncbi.nlm.nih.gov/sites/myncbi/1-OQeHUjYyWk0/bibliography/52116297/public/?sort=date&%20direction=ascending | https://www.dropbox.com/s/6z82jj1gzxe2sb8/Park_biosketch_2023Jan.docx?dl=0 | https://www.dropbox.com/s/2n33ii1y09asrti/Park_CV2023April.docx?dl=0 | 4 | , I have a strong background and training on adaptive clinical trial designs from MD Anderson Cancer Center. During the postdoctoral training, I developed novel clinical trial designs for precision medicine and cancer immunotherapy. I continuously have researched for clinical trials and clinical practice. I collaborated with oncology investigators across the cancer research continuum, including those in the basic, clinical, and population sciences at Hollings Cancer Center (HCC), and stroke researchers through Data Coordination Unit at Medical University of South Carolina. I served as a member of HCC’s Protocol Review Committee to assist with the scientific review of investigator-initiated trials, protocols initiated by outside investigators, and industry-sponsored trials. Since joining University of Wisconsin (UW), I have collaborated with researchers at UW Comprehensive Cancer Center and Cancer Prevention Clinical Trials Network Data Management, Auditing, and Coordinating Center. | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | Yes | No | ||||||||||||||||
| Biykem | Bozkurt | Baylor College of Medicine | North America (Texas, Central Time) | bbozkurt@bcm.edu | (713) 898-8336 | https://www.bcm.edu/people-search/biykem-bozkurt-18610 | 4503 Merrie Lane | Bellaire TX 77401 | MD | - Cardiovascular Disease - Clinical Trials | - Cardiovascular Disease | https://scholar.google.com/citations?user=3jcZzboAAAAJ&hl=en | https://pubmed.ncbi.nlm.nih.gov/?term=bozkurt+biykem&sort=date | https://www.acc.org/latest-in-cardiology/articles/2021/12/01/15/38/biykem-bozkurt-md-phd-facc-named-new-editor-in-chief-of-jacc-heart-failure https://hfsa.org/biykem-bozkurt-md-phd-fhfsa https://esc365.escardio.org/person/229852 | 23 | I have served as a PI, co-I, DSMB member, Clinical End Points Committee or Steering Committee member of clinical trials in heart failure and cardiovascular disease. My experience has been both in federally funded NIH, VA grants as well as industry sponsored clinical trials. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert | Yes | Anthem HFrEF Trial (Autonomic REGULATION Therapy to Enhance Myocardial Function and Reduce progression of Heart Failure with reduced ejection fraction) Data Safety Monitoring Committee member, Liva Nova | Phase 2, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Assess the Effectiveness of CRD-740 (PDE9 inhibitor) in Subjects with Chronic Heart Failure Cardurion | NHLBI Observational Study Monitoring Board (OSMB) for the HeartShare Study | HERMES Trial EX6018-4758 ZEUS/EX6018-4915, Novo Nordisk | PI initiated trials at BCM | Yes | Yes | |||||||||
| Jason | Connor | ConfluenceStat LLC | North America (Florida, Eastern Time) | jason@confluencestat.com | 412-860-3113 | 3102 NW 82nd Way | Cooper City FL 33024 | PhD | - Biostatistics - Clinical Trials - Health Policy | - Cardiovascular Disease - Critical Care Medicine - Immunology - Infectious Disease - Neurology/Neurosurgery - Oncology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Respiratory Disease - Surgery | https://scholar.google.com/citations?hl=en&user=c2z8AHEAAAAJ | http://www.confluencestat.com/about.html | https://0201.nccdn.net/4_2/000/000/01e/20c/connorCV.pdf | 23 | I have design and analyzed hundreds of trial, specializing in Bayesian adaptive trials. Serve on 30+ FDA advisory committees and served on 40+ DMCs including chairing 8. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | GBM AGILE: Glioblastoma (GBM) Adaptive, Global, Innovative Learning Environment | HEALEY ALS (Amyotrophic Lateral Sclerosis) Platform Trial | I-SPY COVID-19: An Adaptive Platform Trial for Critically Ill Patients | I-SPY 2.2 Breast Cancer Platform Trial | SPRY: Strategies to Promote ResiliencY: An Adaptive Randomized Clinical Trial of Metformin in High Risk Surgical Patients | ATTACC: Antithrombotic Therapy to Ameliorate Complications of COVID-19 | PRO BIO II: An adaptive and randomized multi-arm biomarker driven phase 2 study in men with castrate resistant prostate cancer | PRUDENCE: Platform randomised controlled trial of point of care diagnostics for enhancing the quality of antibiotic prescribing | REMAP-CAP: Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community-Acquired Pneumonia (Vice-Chair) | COMPASS: PCORI-funded trial on Comprehensive Post-Acute Stroke Services | No | Yes | |||||
| Amin | Yehya | Eastern Virginia Medical School, Senata Heart Hospital | North America (Virginia, Eastern Time) | amin.yehya@gmail.com | (404) 933-9445 | 9541 23rd Bay St | Norfolk, VA 23518 | MD Other (MS) | - Cardiovascular Disease - Other (Heart failure, mechanical circulatory support, heart transplant, advanced heart failure) | - Cardiovascular Disease | https://scholar.google.com/citations?user=lS03qHIAAAAJ&hl=en | Dr. Yehya is an advanced heart failure, mechanical circulatory support and heart transplant Cardiologist. He is the medical director for the mechanical circulatory support program at Sentara Healthcare and Associate Professor of Medicine at Eastern Virginia Medical School, Norfolk, Virginia. Dr. Yehya earned his Medical Degree at American University of Beirut, Internal Medicine residency at Emory University, Cardiovascular Diseases fellowship at the Medical College of Georgia, and his Advanced Heart Failure and Transplantation fellowship at Stanford University. Dr. Yehya is a Fellow of the American College of Cardiology, Fellow of Heart Failure Society of America (HFSA). He is also a member of the Alpha-Omega-Alpha honorary medical society. Dr. Yehya is a principal and co-investigator for multiple clinical trials. His work in research garnered him an award for top investigator research award by the HFSA. He has published in peer-reviewed journals and has presented his work in national and international conferences. He also served as reviewer for high impact medical journals. He is an editor for book: "Heart Failure: What A Non-Heart Failure Specialist Needs to Know". Dr. Yehya is the editor of the heart failure section of US Cardiology Review journal. | https://drive.google.com/file/d/1uEAoft6MambyQfBTbU9WLb0hPaO0Vo52/view?usp=sharing | 10 | I have attended the DSMB training organized by the Heart Failure Collaboratory Netwrok at the FDA, June 2023. I have been a principal and co-investigator on multiple clinical trials and my site was the third highest enrolling sites in one of the clinical trials in North America. I was awarded Top Investigator Research Award by the HFSA. I am also the principal investigator on multiple site investigator initiated trials. | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert | Yes | Yes | Yes | |||||||||||||||
| John | Hepler | Wake Forest School of Medicine | North America (North Carolina, Eastern Time) | jhepler@wakehealth.edu | 13366923034 | 166 Juniper Cir | Master's degree | - Other (Programming) | 21 | Build electronic data capture system to support large clinical trials. | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | No | No | No | |||||||||||||||||||||
| Richard | Kotz | NAMSA | North America (Maryland, Eastern Time) | rkotz@namsa.com | 240-472-8154 | https://namsa.com/consultants/richard-kotz/ | 6 CHAREN CT | Potomac, MD 20854 | Master's degree | - Biostatistics - Clinical Trials | - Cardiovascular Disease - Diabetes - Neurology/Neurosurgery - Pulmonary Disease - Radiology - Respiratory Disease - Surgery | https://namsa.com/consultants/richard-kotz/ | 33 | Participation in 100's of medical device clinical trials while serving for 25 years as an FDA biostat reviewer and team leader for a wide variety of clinical areas and 7 years consultant on scores of medical device clinical trail advising on study design, protocols, and SAPs. Have served on over a dozen DSMB's. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | Cochlear CI-Dex | Spectranetics Illumenate Below the Knee Stent study | Bioventrix Alive Study | Sensonics glucose monitor PAS study | Bluewind Medical urinary incontinence study | co-chair Nuvaira Airflow 3 | No | Yes | ||||||||||
| Vandana | Mathur | MathurConsulting | North America (California, Pacific Time) | md@mathurconsulting.com | (415) 350-4307 | https://www.linkedin.com/in/mathurconsulting/ | 25 Upenuf Road | Suite 100 | Woodside, CA 94062 | MD | - Clinical Trials - Immunology - Nephrology - Other (Pain, itch, some aspected of Women's Health) | - Immunology - Nephrology - Neurology/Neurosurgery - Ophthalmology - Pulmonary Disease | https://scholar.google.com/citations?user=Xk_zXFAAAAAJ&hl=en | Dr. Vandana Mathur, M.D., FASN, is a nephrologist, clinical trialist, and a Fellow of the American Society of Nephrology. She was faculty on the Renal Transplant Service at the University of California San Francisco (UCSF) and a consultant for the UCSF Drug Studies Unit. Since 2000, Dr. Mathur has served as the president of a clinical drug development consulting company specializing in the design, conduct, and regulatory submission of clinical trials for pharmaceutical companies. Her clinical development therapeutic area work has spanned multiple therapeutic areas including nephrology, cardiology, hematology, oncology, women's health, pain as well as drug-device combination products. Prior to founding MathurConsulting, Dr. Mathur worked for several Silicon Valley biotechnology companies, ultimately in the role of Vice-President of Clinical Development and Medical Affairs. In these various roles, she has been integrally involved in the filing of 14 New Drug Applications. She has lectured extensively in the United States and abroad, is the recipient of multiple teaching awards, has published several dozen peer-reviewed publications and book chapters, and is an inventor on 10+ patents. Dr. Mathur graduated from the University of Pennsylvania in Philadelphia with Honors in Biology and from the University of Pennsylvania School of Medicine. She then completed a nephrology and transplantation fellowship and the Clinical Scholars Program in epidemiology and biostatistics at the UCSF. She maintains an active clinical practice in San Francisco. | https://www.dropbox.com/scl/fi/5vut5rprjhg2yvc71ph89/Mathur-Jan-2023-curriculum-vitae_with-citations.pdf?rlkey=1ggn58z71uyg5yqed92js2zh2&dl=0 | 26 | ~23 years of clinical trial experience within the pharmaceutical industry including strategy, protocol development, all aspects of clinical trial execution, data interpretation, and regulatory submissions. Trials have spanned from Phase 1 to global Phase 3 studies. I have coordinated and written charters for multiple DSMBs/DMCs, Steering Committees, and Endpoint Adjudication Committee. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert | Yes | nephrology industry study | pulmonary industry study | rheumatology industry study | itch industry study | ophthalmology industry study | rheumatology industry study | No | Yes | |||||||
| Cody | Chiuzan | Feinstein Institute for Medical Research, Northwell Health | North America (New York, Eastern Time) | cchiuzan@northwell.edu | (919) 793-6266 | https://feinstein.northwell.edu/institutes-researchers/our-researchers/cody-chiuzan-phd | 19 Baker Hill Road | Great Neck, NY, 11023 | PhD | - Biostatistics - Cardiovascular Disease - Clinical Trials - Diabetes - Infectious Disease - Oncology - Pediatrics | https://scholar.google.com/citations?user=9QeBHnUAAAAJ&hl=en | https://feinstein.northwell.edu/institutes-researchers/our-researchers/cody-chiuzan-phd | 10 | I have served as a lead statistician on more than 25 investigator-initiated clinical trials and responsible for all statistical aspects including study design, data management and analysis. At Columbia University I was affiliated with the Herbert Irving Cancer Center and served for four years in the Protocol Review Committee and ad-hoc reviewer for the IRB. I have served as a statistical mentor for several ASCO YIA awardees and as faculty/mentor in the SITC Clinical Immuno-Oncology Network (SCION) Workshop. | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | Yes | No | ||||||||||||||||
| OHwW | uVgp | (wsZT | EXGV | fisN | kMIO | DukU | PhD MD Other doctoral degree Master's degree Bachelor's degree Other (VtYF) | - Bioinformatics - Biostatistics - Cardiovascular Disease - Clinical Informatics - Clinical Trials - Critical Care Medicine - Diabetes - Epidemiology - Ethics - Health Policy - Immunology - Infectious Disease - mHealth/Mobile Devices - Molecular Chemistry - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pathology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Quality Improvement - Radiology - Respiratory Disease - Surgery - Virology - Other (ObQP) | - Cardiovascular Disease - Critical Care Medicine - Diabetes - Immunology - Infectious Disease - mHealth/Mobile Devices - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pathology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Radiology - Respiratory Disease - Surgery - Virology - Other (rzfC) | wOFh | IOwv | 7765 | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert - Statistician - Ethicist - Patient advocate - Other (jLdM) | Yes | MyFM | Lpus | Znjz | QUgg | DqYU | Yes | Yes | |||||||||||||
| QaFu | nGsU | (Oqlp | hZwd | psUj | TAnO | bVFn | PhD MD Other doctoral degree Master's degree Bachelor's degree Other (nMFH) | - Bioinformatics - Biostatistics - Cardiovascular Disease - Clinical Informatics - Clinical Trials - Critical Care Medicine - Diabetes - Epidemiology - Ethics - Health Policy - Immunology - Infectious Disease - mHealth/Mobile Devices - Molecular Chemistry - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pathology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Quality Improvement - Radiology - Respiratory Disease - Surgery - Virology - Other (ReQC) | - Cardiovascular Disease - Critical Care Medicine - Diabetes - Immunology - Infectious Disease - mHealth/Mobile Devices - Nephrology - Neurology/Neurosurgery - Oncology - Ophthalmology - Pathology - Pediatrics - Psychiatry/Behavioral Sciences - Pulmonary Disease - Radiology - Respiratory Disease - Surgery - Virology - Other (rwzy) | drch | iSBg | 1869 | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert - Statistician - Ethicist - Patient advocate - Other (XDns) | Yes | ExPc | fmLf | pvlY | dlEo | OBVd | Yes | Yes | |||||||||||||
| Xiaoming | Sheng | University of Utah | North America (Utah, Mountain Time) | xiaoming.sheng@utah.edu | (801) 587-5830 | 10 South 2000 East | Salt Lake City, UT 84112 | PhD | - Biostatistics - Clinical Trials - Epidemiology - Ethics | http://www.ncbi.nlm.nih.gov/myncbi/browse/collection/40856465/?sort=date&direction=descending | https://scholar.google.com/citations?user=pWrWTqYAAAAJ&hl=en | 25 | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | Yes | Yes | ||||||||||||||||||
| Jeff | Pan | Ohio State University | North America (Ohio, Eastern Time) | Jeff.pan@osumc.edu | (614) 293-2248 | 1800 Cannon Drive, 250 Lincoln Tower, Columbus, OH 43210 | PhD | - Biostatistics - Clinical Trials - Oncology - Ophthalmology - Psychiatry/Behavioral Sciences | - Oncology - Psychiatry/Behavioral Sciences - Surgery | https://scholar.google.com/citations?user=93Hz2GIAAAAJ&hl=en | https://medicine.osu.edu/find-faculty/non-clinical/biomedical-informatics/xueliang-jeff-pan | https://medicine.osu.edu/find-faculty/non-clinical/biomedical-informatics/xueliang-jeff-pan | 15 | I have led the statistical support teams for more than 30 clinical trials, and served as lead statistician and Co-PI for >100 grant applications for study design. I have served on the DSMC for OSU Comprehensive Cancer Center (>100 trials) for more than 10 years as biostatistician, as well as DSMBs for trials from other academic/non-profit organizations. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | No | Yes | ||||||||||||||||
| Scott | Grey | Uniformed Services University of the Health Sciences | North America (Maryland, Eastern Time) | scott.grey.ctr@usuhs.edu | (216) 533-8736 | 5225 Pooks Hill Rd, Apt 1020N | 6720B Rockledge Dr, Rm 310 | Bethesda, MD 20817 | PhD | - Biostatistics - Cardiovascular Disease - Critical Care Medicine - Surgery | - Critical Care Medicine - Nephrology - Surgery | https://www.ncbi.nlm.nih.gov/myncbi/1jyptwd9go9gDm/bibliography/public/ | As a biostatistician in the Surgical Critical Care Initiative, Uniformed Services University of the Health Sciences, much of my work involves developing machine learning algorithms that utilize complex biomarker data to create computerized decision guidance tools that can be quickly deployed in the care of critically injured patients. This builds on my past work at the University of Michigan where machine learning and other statistical tools were used to identify important risk factors, risk stratify patients and risk-adjust hospital comparisons to improve the treatment of peripheral vascular disease. My statistical expertise also includes mixed effects models for longitudinal and clustered data, statistical methods for handling missing data and a special interest in statistical methods for causal inference, including propensity scores, statistical mediation, compiler average causal effects and targeted maximum likelihood estimation. | 23 | • Served as lead statistician for multiple NIH clinical trial networks and large prospective observational studies • With senior staff and clinical investigators, developed statistical analysis plans to meet NIH and FDA reporting requirements • Created analytic portions of reports for network steering committees, data safety monitoring boards, NIH FDA oversight committees | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | University of Wisconsin, Department of Surgery | Yes | No | ||||||||||||||
| Rafael | Escandon | DGBI Consulting LLC | North America (Washington, Pacific Time) | Rafael.Escandon@gmail.com | (415) 425-3705 | 5256 NE Old Mill Road | Bainbridge Island WA 98110 | PhD Other doctoral degree Master's degree | - Cardiovascular Disease - Clinical Trials - Ethics - Pediatrics - Other (Rare Inherited Diseases, Gene Therapy) | - Cardiovascular Disease - Oncology - Pediatrics - Other (Rare Genetic Diseases) | https://www.ncbi.nlm.nih.gov/myncbi/rafael.escandon.1/bibliography/public/ | Cardiovascular physiologist with advanced training in epidemiology and public health, as well as bioethicist/certified clinical ethicist who has completed an advanced program in pediatric medical ethics. Spent 30 years in clinical research and development across numerous indications, and having contributed to seven approved novel products. | https://www.linkedin.com/in/rafael-escandon-b23596/ | 30 | 3 decades of clinical development/clinical trial design and execution experience, primarily in cardiovascular diseases, metabolic, early oncology, neurology, and rare inherited diseases. Significant experience in global clinical trials with small molecules and biologics. My last decade has been spent working with advanced therapies (Gene Therapies, ASO's and precision medicines) in rare (mostly pediatric) genetic diseases. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Ethicist - Patient advocate - Other (clinical trial expert) | Yes | Confidentiality prevents disclosure | None | No | Yes | |||||||||||||
| Rafa | Escandon | DGBI Consulting LLC | North America (Washington, Pacific Time) | Rafael.Escandon@gmail.com | (415) 425-3705 | 5256 NE Old Mill Road | Bainbridge Island WA 98110 | PhD Other doctoral degree Master's degree | - Cardiovascular Disease - Clinical Trials - Ethics - Pediatrics - Other (Rare Inherited Diseases, Gene Therapy) | - Cardiovascular Disease - Oncology - Pediatrics - Other (Rare Genetic Diseases) | https://www.ncbi.nlm.nih.gov/myncbi/rafael.escandon.1/bibliography/public/ | Cardiovascular physiologist with advanced training in epidemiology and public health, as well as bioethicist/certified clinical ethicist who has completed an advanced program in pediatric medical ethics. Spent 30 years in clinical research and development across numerous indications, and having contributed to seven approved novel products. | https://www.linkedin.com/in/rafael-escandon-b23596/ | 30 | 3 decades of clinical development/clinical trial design and execution experience, primarily in cardiovascular diseases, metabolic, early oncology, neurology, and rare inherited diseases. Significant experience in global clinical trials with small molecules and biologics. My last decade has been spent working with advanced therapies (Gene Therapies, ASO's and precision medicines) in rare (mostly pediatric) genetic diseases. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Ethicist - Patient advocate - Other (clinical trial expert) | Yes | Confidentiality prevents disclosure | None | No | Yes | |||||||||||||
| Emine | Bayman | University of Iowa | North America (Iowa, Central Time) | emine-bayman@uiowa.edu | (319) 467-1301 | https://www.public-health.uiowa.edu/people/emine-bayman/ | Clinical Trials Statistical & Data Managmnt Center | N509, 145 N. Riverside Drive, CPHB | PhD | - Biostatistics - Clinical Trials - Neurology/Neurosurgery - Psychiatry/Behavioral Sciences - Other (Pain and anesthesia studies) | - Nephrology - Neurology/Neurosurgery | https://scholar.google.com/citations?user=Q2RggYQAAAAJ&hl=en&oi=ao | Dr. Bayman is an associate professor of biostatistics with a secondary appointment in the Department of Anesthesia. Dr. Bayman is the Deputy Director of the Clinical Trials Statistical and Data Management Center (CTSDMC) and has over 15 years of experience providing statistical design expertise to multi-center clinical trials. Dr. Bayman has served as a Principal Investigator, a co-investigator, or a primary statistician for multiple NIH and/or industry-funded studies. Dr. Bayman has a deep understanding of translating clinical questions to study designs and has combined expertise in leading both small and large multicenter clinical trials. Dr. Bayman has published extensively on the transition from acute to chronic postsurgical pain, Bayesian outlier detection, Bayesian clinical trial design, and general multi-center clinical trial design. | 20 | I am the Deputy Director of the Clinical Trials Statistical and Data Management Center at the University of Iowa. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | No | No | |||||||||||||||
| Colin | Begg | Memorial Sloan Kettering Cancer Center | North America (New York, Eastern Time) | beggc@mskcc.org | (646) 227-3395 | https://www.mskcc.org/research/ski/labs/colin-begg | Department of Epidemiology and Biostatistics | Memorial Sloan Kettering Cancer Center | 1275 York Ave, New York NY 10021 | PhD | - Biostatistics - Clinical Trials - Epidemiology - Oncology | - Oncology - Ophthalmology - Surgery | https://scholar.google.com/citations?user=LapXNYYAAAAJ&hl=en&oi=ao | https://www.mskcc.org/research/ski/labs/colin-begg | 40 | I have long experience as an academic investigator conducting research on statistical method applicable to clinical trials, epidemiology and other topics, focusing mostly on cancer applications. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | CPEP Trial for Pre-Eclampsia Prevention (NICHD) | Human Growth Hormone Trial in Turner Syndrome (NIH) | Children’s Cancer Group (NCI) | Colchicine in the Treatment of Alcoholic Cirrhosis of the Liver (VA) | NSABP-CIRE “BETH” trial of breast cancer | Study of Tamoxifen and Raloxifene (NSABP) | MSK Intramural DSMB | No | Yes | |||||||
| Nuru | Noor | University of Cambridge | Europe | noorn@doctors.org.uk | +447545314050 | https://orcid.org/0000-0003-3426-6408 | 284 Elmsleigh Drive | Leigh-on-sea | Essex, SS94JR | PhD MD Master's degree Bachelor's degree | - Clinical Trials - Other (Gastroenterology) | https://pubmed.ncbi.nlm.nih.gov/?term=nurulamin+noor&sort=date&size=200 | Nuru is a Clinical Lecturer in Gastroenterology based at the University of Cambridge in the UK. He was the Clinical Research Fellow and Principal Investigator for the PROFILE Trial, one of the largest academic trials in the field of Inflammatory Bowel Disease (IBD) ever performed from the UK and indeed one of the largest around the world - using a novel biomarker-stratified, trial design and with a focus on pragmatic and decentralised delivery. He is interested in getting faster answers through the use of efficient trial designs, particularly in the setting of IBD and other similar immune-mediated inflammatory diseases (IMIDs). | https://orcid.org/my-orcid?orcid=0000-0003-3426-6408 | 12 | Principal Investigator Lead Investigator Research Ethics Committee Member Clinical trials funding Committee Member Clinical trials funding Reviewer | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert | No | Yes | Yes | ||||||||||||||
| James | Anderson | University of Nebraska Medical Center College of Public Health | North America (Pennsylvania, Eastern Time) | jamesanderson108@gmail.com | (402) 981-0217 | https://www.unmc.edu/publichealth/departments/biostatistics/facultyandstaff/james-anderson.html | 308 South Main Street | North Wales, PA 19454 | PhD | - Biostatistics - Clinical Trials - Ethics - Oncology - Pediatrics | - Cardiovascular Disease - Oncology - Pediatrics | https://scholar.google.com/citations?user=Qr_1qxAAAAAJ&hl=en | I was an academic statistician for 38 years, holding faculty positions at the University of Southern California, the Harvard School of Public Health, the University of Nebraska Medical Center and the University of Wisconsin, Madison. During this time, I taught and worked with several NCI CTEP-funded cooperative groups (see below). I finished my career with 9 years with Merck and Co. | https://www.unmc.edu/publichealth/_documents/anderson_james_cv_9-2023.pdf | 47 | During my career, I served as a statistician for the Children's Cancer Group, Eastern Cooperative Oncology Group, the Cancer and Leukemia, Group B (as Group Statistician), the Intergroup Rhabomyosarcoma Study Group (as Group Statistician), and the Children's Oncology Group (as Group Statistican). I also served as Merck Distinguished Scientist for melanoma trials and external collaborations | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | Eastern Cooperative Oncology Group (ECOG) DMC | European Pediatric Soft Tissue Sarcoma Group (EpSSG) DMC | Children's Oncology Group (COG) DMC | Merck DMC for melanoma studies KN-002 and KN-006 | DMC for prior Amgen study | No | Yes | |||||||||
| SHOLA DR | ADEYEMI | STATSXPERTS CONSULTING LIMITED | Europe | SHOLA@STATSXPERTS.COM | 07534720855 | https://WWW.STATSXPERTS.COM | GUILDHALL | MARKET SQUARE | CAMBRIDGE, UNITED KINGDOM | PhD | - Biostatistics - Clinical Trials - Epidemiology - Infectious Disease - mHealth/Mobile Devices - Oncology - Respiratory Disease | - Immunology - Infectious Disease - mHealth/Mobile Devices - Oncology - Radiology - Virology | https://www.researchgate.net/profile/Shola-Adeyemi | https://scholar.google.com/citations?user=LwLBe2wAAAAJ&hl=en | Shola is a highly experienced biostatistician with a focus on regulatory submission, an exceptional level of expertise in the field of biostatistics and its application to the pharmaceutical and healthcare industries. His experience involves collaborating with researchers and medical professionals to design, analyze, and interpret clinical trials and studies in a manner that adheres to stringent regulatory requirements set forth by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), The Pharmaceuticals and Medical Devices Agency (PMDA), and National Medical Products Administration (NMPA) as well as engaging with these agencies in collaboration with regulatory colleagues for protocol/submission purposes. Thus has led to many successful regulatory submissions and marketing authorisations. Shola has experience in CDISC: STDM, ADaM and Define.xml. | 20 | experience involves collaborating with researchers and medical professionals to design, analyze, and interpret clinical trials and studies in a manner that adheres to stringent regulatory requirements set forth by agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), The Pharmaceuticals and Medical Devices Agency (PMDA), and National Medical Products Administration (NMPA) as well as engaging with these agencies in collaboration with regulatory colleagues for protocol/submission purposes. Thus has led to many successful regulatory submissions and marketing authorizations. Shola has experience in CDISC: STDM, ADaM and Define.xml. | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | Yes | SIRFLOX | FOXFIRE | SIRCCA | BIOCAPTIS | .... | Yes | Yes | ||||||||
| Cara | Joyce | Loyola University Chicago | North America (Illinois, Central Time) | carajoycebiostats@gmail.com | 13123912999 | https://carajoycebiostats.com/ | 409 Washington Blvd | 1E | Oak Park, IL 60302 | PhD | - Biostatistics - Clinical Informatics - Clinical Trials - Epidemiology | - Cardiovascular Disease - Other (Gastroenterology) | https://www.ncbi.nlm.nih.gov/myncbi/cara.joyce.1/bibliography/public/ | https://carajoycebiostats.com/ | 15 | Lead or supporting biostatistician on investigator initiated and industry trials | Yes ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | No | No | ||||||||||||||
| Nael | Abdelsamad | North America (Louisiana | naa2015@qatar-med.cornell.edu | (385) 237-9811 | 4601 Murano Road | MD Master's degree Other (FACHE, CPI) | - Clinical Trials - mHealth/Mobile Devices - Pediatrics - Quality Improvement | https://www.researchgate.net/profile/Nael-Abdelsamad | Certified principal investigator who recently served as the Medical Director of Patient Recruitment at CVS Health's Clinical Trial Services, where I was part of the Medical Affairs team. I led the scientific review, screening, and analysis of recruitment study opportunities for the Clinical Trial Services. My career has spanned multiple aspects of research support, including trial management, strategic planning, administration, and operations. Before joining CVS Health CTS, I served as Director of the HEAL (Helping to End Addiction over the Long-term) Pain Effectiveness Research Network at the University of Utah, an NIH-funded network working to stem the national opioid crisis. Currently serve as a board member on Advarra's IBC and as the president of the ACRP Greater Salt Lake Chapter. | https://www.linkedin.com/in/naelabdelsamad | 12 | • Certified Principal Investigator & Fellow of the American College of Healthcare Executives • 12 years of clinical development and clinical operations experience involving design, execution, and analysis of phase 1 – 3 clinical trials across a broad set of therapeutic areas | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert - Patient advocate | No | Yes | No | ||||||||||||||||||
| ANDRE | LAMY | McMaster University | North America (Canada, Eastern Time) | alamy1@mac.com | 905-518-9805 | Population Health Research Institute | DBCVSRI C1-112 237 Barton St East | Hamilton, ON L7M 4J4 CANADA | MD Master's degree | - Cardiovascular Disease - Clinical Trials - Surgery | - Cardiovascular Disease - Surgery | Andre Lamy MD MHSc I am a cardiac surgeon practicing at the Hamilton Health Sciences since 1996. I am also a Professor in the Department of Surgery at McMaster University and a member of the Division of Perioperative Care at McMaster University. My research is performed as a Scientist of the Population Health Research Institute in Hamilton (peri-operative group). I have been involved in clinical research for over 25 years and have collaborated with many research groups, pharmaceutical and medical device companies worldwide. My research has focused on large randomized controlled trials (RCT) in cardiac surgery and health economics. My most significant contribution in cardiac surgery is the CORONARY trial for which I received a large grant from the Canadian Institute of Health Research in 2007. CORONARY was a large multi centered randomized trial of off-pump CABG surgery versus on-pump CABG surgery. CORONARY has recruited and randomized 4,752 patients from 79 centers in 19 countries. The results were presented at the Late Breaking Clinical Trials at the American College of Cardiology meeting in 2012 and 2013. The results were published in the New England Journal of Medicine in 2012, 2013 and 2016 More recently, I was the lead for the COMPASS-CABG trial, a subgroup of the main COMPASS trial investigating rivaroxaban 2.5 mg BID in patients with coronary artery and cerebrovascular disease. The results of COMPASS-CABG were published in the Journal of the American College of Cardiology in 2019 and subsequent manuscripts in JAMA Cardiology and JTCVS on IMA skeletonization and IMA patency. During my career I have also led economic analyses for many large trials such as HOPE, CURE, ONTARGET, ACTIVE-A, TIMACS, TRANSFER-AMI, ORIGIN, CORONARY and HOPE-3, MANAGE and TIPS-3. The economic findings of all these trials have been published in various journals. More recently I published economic analyses of the successful COMPASS and LAAOS III trials. My present interest is in reducing complications in cardiac surgery. We have just completed a large RCT testing topical tranexamic acid (versus intravenous) to decrease seizures and blood transfusions in cardiac surgery (DEPOSITION trial). I am also involved in many trials sponsored by the pharmaceutical industry, enrolling patients and leadership positions. | 25 | Cardiac surgery, ECMO | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Medical expert | No | Yes | No | ||||||||||||||||
| Jayme | Koltsov | Stanford University | North America (California, Pacific Time) | jcbk@stanford.edu | (650) 723-3079 | 450 Broadway MC 6342 | Redwood City, CA 94063 | PhD | - Biostatistics - Epidemiology - Surgery - Other (Orthopaedic Surgery) | https://www.ncbi.nlm.nih.gov/myncbi/1bctCwj_O9cAw/bibliography/public/ | https://scholar.google.com/citations?user=Yk0I95cAAAAJ&hl=en&oi=sra | Dr. Koltsov is an expert in clinical and translational orthopaedic research design and biostatistics with an incredibly unique and valuable combination of skill-sets. Her foundation from her Ph.D. in orthopaedic biomechanics provides an understanding of the underlying anatomy, pathology, and mechanics not typical for a biostatistician. This background empowers effective and efficient communication with clinicians and scientists and enables Dr. Koltsov to develop study designs and analytic strategies exceptionally tailored to the physical orthopaedic problems under investigation. Dr. Koltsov has an extensive knowledge base in research methodology and statistical methods honed from her PhD onward, including univariate statistics (parametric, non-parametric, and categorical); survival analysis (Kaplan Meier and Cox proportional hazards); multivariable and longitudinal data analyses (logistic regression, generalized linear modeling, linear mixed models, and generalized estimating equations); quasi-experimental techniques for reducing bias (propensity score matching and inverse probability treatment weighting); patient reported outcome design and validation; and healthcare economic analysis. Over the past 11 years, Dr. Koltsov has developed a successful track record of collaborating with clinicians and scientists to lead and facilitate high-quality clinical, translational, and health services research spanning many orthopaedic disciplines, including biomechanics, spine, arthroplasty, foot and ankle, upper extremity, trauma, sports medicine, pediatrics, rheumatology, and pain management and rehabilitation. | https://profiles.stanford.edu/jayme-koltsov | 11 | I have extensive experience in designing & implementing analytics for experimental and observational research studies in orthopaedic surgery. I have not yet served on a DSMB, but have served as the statistician on multiple clinical review panels. | No ( -Industry -Academia -Government -Non-profit/Co-operative group ) | - Statistician | No | Yes | No |