Clinical trials are expected to be overseen by a Data and Safety Monitoring Board (also called Data and Safety Monitoring Committee), an independent group of experts who monitor, first and foremost, the safety of the trial participants as well as the efficacy of the intervention. DSMBs have access to all the data generated by a clinical trial as soon as it’s available, and the DSMB can recommend that a trial be paused or stopped entirely if the risks of the intervention appear to be too great for participants — such as a pattern of very severe adverse events — or the intervention appears so ineffective that the risks outweigh the benefits of completing the trial. The NIH guidelines on DSMBs offer a broad overview of what the group’s responsibilities and powers are, though this may vary by institution.
