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HOW TO SEARCH AND DOWNLOAD REGISTRATION DATA
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 email@example.com.
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 firstname.lastname@example.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|
|Barry||Davis||University of Texas School of Public Health||North America (Texas, Central Time)||email@example.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|
|Kenneth||Mahaffey||Stanford||North America (California, Pacific Time)||firstname.lastname@example.org||(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|
|Jean||Rouleau||University of Montreal||North America (Canada, Eastern Time)||email@example.com||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|
|Sameer||Parpia||McMaster University||North America (Canada, Eastern Time)||firstname.lastname@example.org||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|
|Lewis||Smith||Northwestern University Feinberg School of Medicine||North America (Illinois, Central Time)||email@example.com||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|
|Scott||Evans||George Washington University||North America (Maryland, Eastern Time)||firstname.lastname@example.org||(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)||email@example.com||(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)||firstname.lastname@example.org||(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||Europeemail@example.com||+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||Europefirstname.lastname@example.org||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||Reboussin||Wake Forest University School of Medicine||North America (North Carolina, Eastern Time)||email@example.com||(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|
|David||Kerr||Cytel||North America (Washington, Pacific Time)||firstname.lastname@example.org||(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|
|Haley||Hedlin||Stanford University||North America (California, Pacific Time)||email@example.com||(650) 721-5900||1701 Page Mill Rd||Palo Alto CA, 94304||PhD||- Biostatistics - Clinical Trials - mHealth/Mobile Devices||- Infectious Disease - Pediatrics - Pulmonary Disease - Respiratory Disease||Yes||No||No||No|
|Haley||Hedlin||Stanford University||North America (California, Pacific Time)||firstname.lastname@example.org||(650) 721-5900||https://med.stanford.edu/qsu/current-members/haley_hedlin.html||1701 Page Mill Rd||Palo Alto CA, 94304||PhD||- Biostatistics - Clinical Trials - mHealth/Mobile Devices||- 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||No||Yes||No|
|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|
|Manisha||Desai||Stanford University||North America (California, Pacific Time)||email@example.com||(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|
|Richard||Chappell||University of Wisconsin School of Medicine and Public Health||North America (Wisconsin, Central Time)||firstname.lastname@example.org||(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|
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