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HD InsightsAll Eyes on the Patient: Monitoring Board

The Data and Safety Monitoring Board (DSMB) monitors the safety of study participants and the effectiveness of investigational therapies during the conduct of a clinical trial. The DSMB is a committee composed of a small group of people who periodically review data from the trial, and includes a statistician, clinical experts, and a member of the patient community. A DSMB is set up for all clinical therapeutic trials, but they are not needed for many observational or survey-based studies.

Given the blinded nature of a clinical trial, it is necessary for a small group of statisticians to analyze unblinded data to review potential trends in side effects and clinical symptoms. The plan for timing and nature of the data review is made before the study starts, and the DSMB will have planned meetings to review study results. It is really important to understand the potential risks of study medications, and plan the monitoring of the study early on. The DSMB will review a summary of this data over the course of the study.

The interim data is evaluated for participant safety, study conduct, study progress, and effectiveness of the investigational therapy. For example, the DSBM will make a judgment about whether data is being properly collected, analyzed and reported.

After the DSMB evaluates the data and meets, they make a recommendation regarding whether the trial should be continued as planned, modified or terminated. If there are findings that inform us of adverse effects, the study is unlikely to continue as planned. The decision to stop a study may have significant implications for the question being studied, so there must be overwhelming evidence. In drug and device trials with industry sponsors, and any NIH trial, there are clear guidelines about the role of the DSMB and reporting requirements.

While the DSMB is not an outwardly obvious part of studies, it plays a critical role. The DSMB members and their decisions can have a tremendous impact on the continuation or conduct of studies. Candidates for DSMB service have typically played other roles within a clinical trial, where they have demonstrated clinical acumen and analytical expertise. Ideally, their experience is in the same disease area or an area with similar types of outcome measures.