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The Data and Safety Monitoring Committee: Some final thoughts

The Data and Safety Monitoring Committee: Some final thoughts David L. DeMets, PhD,a and Salim Yusuf, MDb Madison, Wis, and Hamilton, Ontario, Canada The randomized clinical trial (RCT) has become a principal research tool in the evaluation of new medical products, including drugs, biologics, and devices. A critical component of the the RCT in studies that investigate mortality or irreversible morbidity is the Data and Safety Monitoring Committee (DSMC). The American Heart Journal has now published all seven articles in a series that presents the proceedings of a conference on DSMCs that was sponsored by the Duke Clinical Research Institute (DCRI) and the American Heart Journal. It was our privilege to serve with Dr Robert Califf and Dr Kerry Lee as cochairpersons for the conference, and it is our hope that this series on the philosophy and practice of DSMCs will be widely read. As these articles make clear, the DSMC is a vital part of the organizational components of a clinical trial, which includes the Steering (or Executive) Committee, Data Management Center, Statistical Analysis Center (sometimes the latter two are combined into a Data Coordinating Center), and participating clinical centers. The primary charge of a DSMC is to monitor the ongoing trial for safety and for http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png American Heart Journal Elsevier
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