An extensive overview of the complexities surrounding Data and Safety Monitoring Committees (DSMCs) in clinical trials, emphasizing their crucial role in ensuring participant safety and study integrity. Various case studies, such as the Beta-Blocker Heart Attack Trial (BHAT) and the Stroke Prevention in Atrial Fibrillation I Trial (SPAF I), illustrate the difficult ethical and statistical judgments these committees face, particularly when considering early termination for benefit or harm. The text discusses factors influencing monitoring, including trial phase, blinding status, and participant vulnerability, while also detailing the history and structure of these committees, exemplified by the pioneering Coronary Drug Project (CDP). Furthermore, the sources explore nuanced issues like managing composite outcomes, interpreting subgroup analyses, the influence of external information, and navigating regulatory policies, such as the FDA’s use of interim data for accelerated approvals.
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