RL21 Challenges & Issues Faced by Clinical Trial Data Monitoring Committees in Clinical Trials with Adaptive Designs
*Yan Wang, U.S. Food and Drug Administration Keywords: 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.
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Key Dates
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April 30 - May 22, 2013
Invited Abstract Submission Open -
June 4, 2013
Online Registration Opens -
August 9 - August 23, 2013
Invited Abstract Editing -
August 23, 2013
Short Course materials due from Instructors -
August 26, 2013
Housing Deadline -
September 9, 2013
Cancellation Deadline and Registration Closes @ 11:59 pm EDT -
September 16 - September 18, 2013
Marriott Wardman Park, Washington, DC