RL21 Challenges & Issues Faced by Clinical Trial Data Monitoring Committees in Clinical Trials with Adaptive Designs
*Yan Wang, U.S. Food and Drug Administration 

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FDA's Guidance on Establishment and Operation of Clinical Trial Data Monitoring Committees (DMC) was published in March 2006. This guidance was intended to assist clinical trial sponsors in determining when a DMC may be useful for study monitoring, and how such committees should operate. This roundtable will discuss potential challenges & issues that a DMC may be encountered in trials with adaptive designs.