Liability issues for data monitoring committee members.
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In randomized clinical trials, a data monitoring committee (DMC) is often appointed to review interim data to determine whether there is early convincing evidence of intervention benefit, lack of benefit or harm to study participants. Because DMCs bear serious responsibility for participant safety, their members may be legally liable for their actions. Despite more than three decades of experiences with DMCs, the issues of liability and indemnification have yet to receive appropriate attention from either government or industry sponsors. In industry-sponsored trials, DMC members are usually asked to sign an agreement delineating their responsibilities and operating procedures. While these agreements may include language on indemnification, such language sometimes protects only the sponsor rather than the DMC members. In government-sponsored trials, there has been even less structure, since typically there are no signed agreements regarding DMC activities. This paper discusses these issues and suggests sample language for indemnification agreements to protect DMC members. This type of language should be included in DMC charters and in all consulting agreements signed by DMC members.
Published Version (Please cite this version)10.1191/1740774504cn54oa
Publication InfoCaliff, Robert M; DeMets, David Leon; Fleming, TR; Massie, B; Meisel, A; Merchant, T; ... Wittes, J (2004). Liability issues for data monitoring committee members. Clin Trials, 1(6). pp. 525-531. 10.1191/1740774504cn54oa. Retrieved from http://hdl.handle.net/10161/11003.
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Donald F. Fortin, M.D. Professor of Cardiology, in the School of Medicine
Robert Califf, MD MACC, is the Donald F. Fortin, MD, Professor of Cardiology. He is also Professor of Medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the Commissioner of Food and Drugs in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational
Professor of Biostatistics & Bioinformatics
Frank has had diverse research interests and consulting experience in industry and academia including clinical trials design, data monitoring, benefit/risk, and most recently, safety and pharmacovigilance. He has been a leader in the scientific community in promoting data disclosure and transparency in clinical research. In addition his role of full-time Professor of Biostatistics and Bioinformatics at Duke Clinical Research Institute, Frank is also Managing Partner of HunterRock
Alphabetical list of authors with Scholars@Duke profiles.