Data Safety Monitoring Board: Composition and Role

Abstract

A clinical data safety monitoring board (DSMB) is an independent group of individuals with pertinent expertise that reviews on a regular basis accumulating data from one or more ongoing clinical trials. The DSMB advises the study sponsor regarding the continuing safety of trial subjects and those yet to be recruited to the trial. The DSMB periodically reviews the scientific integrity, studies safety results, evaluates the critical efficacy endpoints and intervals, considering the clinical events committee’s adjudications of events, determines whether the basic trial assumptions remain valid, and makes recommendations to the sponsor. Typically, a charter is drafted for each study and constitutes the anticipated procedures of the DSMB as it relates to the safety and protection of trial participants and critical efficacy endpoints of the research.