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Data safety monitoring committees should not include sponsors -- FDA's Temple.

Executive Summary

INDEPENDENT DATA MONITORING COMMITTEES SHOULD NOT INCLUDE SPONSOR as a direct participant, FDA Center for Drug Evaluation & Research Associate Director for Medical Policy Robert Temple, MD, told a Sept. 13 agency workshop on human subject protection. "These committees recommend actions to sponsors, they don't take action," Temple observed. "The sponsor is going to be there before anything happens."

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