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When Should Data and Safety Monitoring Committees Share Interim Results in Cardiovascular Trials?
Jeffrey S. Borer, MD;
David J. Gordon, MD, PhD, MPH;
Nancy L. Geller, PhD
JAMA. 2008;299(14):1710-1712.
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Data and safety monitoring committees (DSMCs) often are empanelled in randomized controlled trials (RCTs), especially multicenter trials, when primary end points include mortality and major morbidity. These committees periodically review safety and efficacy data and, based on their benefit-to-risk assessment, recommend to the sponsor whether the trial should continue and if so, whether modifications are necessary. Primarily, the DSMC must minimize risks to trial participants. Sponsors and investigators of RCTs help ensure external credibility by delegating oversight to an external committee. Although cultural differences may affect regional perceptions in the increasingly frequent multinational trials, external, independent DSMCs are accepted throughout the world.
Appreciation of the potential utility of DSMCs1 and their increasing application to clinical trials1 has led to efforts to establish standards for their structure and function. These nonmandatory recommendations include the 2006 US Food . . . [Full Text of this Article] Midcourse Trial Corrections
Author Affiliations: Weill Cornell Medical College of Cornell University, New York, New York (Dr Borer); and National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland (Drs Gordon and Geller).
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