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December 13, 2016

Enhancing the Scientific Integrity and Safety of Clinical Trials: Recommendations for Data Monitoring Committees

Author Affiliations
  • 1Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California
  • 2Berry Consultants LLC, Austin, Texas
  • 3Office of Medical Policy, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland
  • 4Office of the Clinical Director, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland
  • 5Department of Biostatistics and Medical Informatics, University of Wisconsin, Madison

Copyright 2016 American Medical Association. All Rights Reserved.

JAMA. 2016;316(22):2359-2360. doi:10.1001/jama.2016.16070

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.