A Data and Safety Monitoring Board (DSMB), also referred to as a Data Monitoring Committee (DMC), plays a critical role in safeguarding participant safety and ensuring the integrity of clinical trials. This article provides a narrative overview of best practices in DSMB structure, governance, and operations, informed by regulatory guidance from the U.S. Food and Drug Administration (FDA), National Institutes of Health (NIH), European Medicines Agency (EMA), and selected literature, as well as practical experience in clinical trial oversight. Key domains addressed include DSMB composition and independence, charter development and governance, data access and integrity, safety monitoring processes, interim analyses and adaptive decision-making, confidentiality, and sponsor responsibilities. The article also discusses common operational challenges and mitigation strategies, along with emerging trends such as Bayesian monitoring approaches and decentralized trial oversight. Rather than prescribing specific statistical thresholds, the manuscript emphasizes principles for maintaining scientific rigor, ethical oversight, and regulatory alignment. This overview is intended to support sponsors, Clinical Research Organizations (CROs), and DSMB members in implementing effective and compliant safety monitoring practices across a range of clinical trial settings.
Klein et al. (Fri,) studied this question.