Data Safety Monitoring Boards: Their Place and Role in Trials

Dr Roma Chilengi, Head of Clinical Trials at the Kenya Medical Research Institute (KEMRI)/Wellcome Trust Research Programme in Kilifi, Kenya discusses clinical trial data safety monitoring boards (DSMBs). This introduction starts with a definition of a DSMB and discusses their roles and when they are required. DSMS constitutions, charters and considerations for under developed settings are also discussed.

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The goal of the Global Health Clinical Trials Programme is to promote and make easier the conduct of non-commercial clinical research across all diseases in resource-poor settings. We present a series of short lectures to provide an introduction to clinical trials and explore some of the challenges facing clinical trialists in resource-limited settings.