A Data and Safety Monitoring Board (DSMB) is an independent oversight body that reviews interim clinical trial data to evaluate safety, study conduct, and emerging efficacy or futility signals.
DSMBs assess adverse events, enrollment patterns, protocol adherence, and outcome trends at scheduled timepoints without compromising study integrity. Their recommendations may include continuing as planned, implementing protocol modifications, or stopping early for safety or efficacy reasons. DSMBs are especially common in high-risk, late-phase, or publicly funded studies. Independent monitoring strengthens participant protection and regulatory confidence in trial governance.