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The risks of participating in a clinical trial cannot be predicted with certainty at the time of trial design, especially when evaluating novel therapies. Accordingly, once the trial is initiated, periodic and ongoing review of accumulating study data is necessary to ensure the continued appropriateness of enrolling and treating patients in the trial. This oversight activity is often conducted by a data monitoring committee (DMC), also known as a data and safety monitoring board, generally composed of scientific, medical, statistical, and other experts. Ideally, this oversight process ensures that a clinical trial is stopped if the benefit-risk balance for participants or the expected value to society no longer justifies continuing.
Lewis RJ, Calis KA, DeMets DL. Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees. JAMA. 2016;316(22):2359–2360. doi:10.1001/jama.2016.16070
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