DSMB

DSMB or Data Safety Monitoring Board is an independent group of experts who monitor patient safety and treatment efficacy data while a clinical trial is ongoing. The DSMB has the authority to stop a study early if there are significant results or if participant safety is at risk.

Role of DSMB

The primary role of a DSMB is to periodically review and evaluate the accumulated study data for participant safety, study conduct and progress, and, when appropriate, efficacy, and make recommendations to the Sponsor concerning the continuation, modification, or termination of the trial.

Composition of DSMB

A DSMB typically consists of clinical trial experts, statisticians, and clinicians knowledgeable in the appropriate disciplines, and who are independent of the organizations sponsoring the trial. The DSMB may also include ethicists and patient representatives.

Responsibilities of DSMB

The responsibilities of a DSMB include, but are not limited to:

• Reviewing research protocols and plans for data safety and monitoring.
• Evaluating the progress of a clinical trial, including periodic assessments of data quality and timeliness, participant risk versus benefit, performance of trial sites, and other factors that can affect the study outcome.
• Making recommendations on whether a trial should continue as originally designed, be changed, or be stopped early.

DSMB Meetings

DSMB meetings are generally closed to persons not directly involved in the trial to maintain the independence of the DSMB and to minimize potential conflicts of interest. The frequency of DSMB meetings depends on the nature of the trial and the type and degree of risks to participants, but they typically occur at least annually.

See Also

• Clinical Trial
• Sponsor (clinical trials)
• Ethics in clinical trials

DSMB Resources
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