A Data Safety and Monitoring Board (DSMB) is an independent group of external experts that makes recommendations to the study sponsor about a clinical trial.
The most common and most recognized purpose of a DSMB is to monitor clinical trials to ensure patient safety and treatment efficacy. The members periodically review and evaluate accumulated study data on participant safety, study conduct and progress, and, when appropriate, efficacy. The DSMB may review unblinded study information at the patient or treatment group level during the study’s conduct. Based on its review, the DSMB provides recommendations to the sponsor regarding study modification, continuation, or termination, considering relevant background knowledge about the disease, test agent, or patient population under study.