Arthur Weinstein, MD, FACP, FRCP, MACR
Attending Rheumatologist Emeritus, MedStar Washington Hospital Center,
Clinical Professor Emeritus of Medicine, Georgetown University
Chief Medical Officer, Exagen Diagnostics, Inc, Vista, CA
Data Safety and Monitoring Boards (DSMBs) or Data Monitoring Committees (DMCs) have been established under U.S. Federal recommendations (21 CFR 312.50 and 312. 56 for drugs and biologics) and the FDA (Establishment and Operation of Clinical Trial Data Monitoring Committees, March 2006). Guided by the Belmont Report on ethical principles for the protection of human subjects of research and with concerns about maintaining scientific integrity of research results, DSMBs have been instituted to independently monitor accumulating data in large clinical trials. Their primary concern is the safety of subject volunteers in blinded randomized trials, often with placebo or standard of care compared to the experimental drug or device. The risk of adverse events is weighed against the potential benefits of the new therapy. Based on assessments of risk and benefit, DSMBs make recommendations to sponsors regarding trial continuation, modification or termination. Given their significant responsibility, members should have requisite expertise and lack of conflicts of interest. This talk will focus on the logistics of DSMB structure and function, the appropriate interactions with the sponsor and the challenges that may arise, citing published literature and personal anecdotes from my role as Chairman of several past and ongoing DSMBs.