What is a Data and Safety Monitoring Board (DSMB)?

A Data and Safety Monitoring Board (DSMB) is an independent group established to ensure the safety and rights of participants in a clinical trial as well as to monitor the efficacy of the treatment being tested. The primary role of a DSMB is to review data related to the trial's progress, specifically focusing on any adverse events and the overall safety of participants. They assess whether the risks to participants are acceptable relative to the potential benefits and whether the trial should continue, be modified, or terminated. This oversight is crucial in maintaining the integrity of the trial and protecting the health of its participants.

In contrast, managing participant recruitment is not within the scope of a DSMB's functions; recruitment is typically handled by the research team or investigators. The DSMB also does not oversee financial interests; such oversight may fall under institutional review boards (IRBs) or similar committees. Additionally, their responsibilities do not involve data analysis after the study's completion, as they focus on monitoring during the trial itself rather than analyzing outcomes once it is over.