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Activity Number: 228
Type: Topic Contributed
Date/Time: Monday, August 5, 2013 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #308163
Title: General Considerations for Data Monitoring of Adaptive Trials
Author(s): Zoran Antonijevic*+
Companies: Cytel
Keywords: DMC ; Adaptive Trials ; Roles ; Responsibilities ; Membership ; Communication

DMCs are facing new challenges and issues associated with emergence of adaptive clinical trials. While decisions may be more complicated with novel adaptive designs, we believe that the fundamental roles and responsibilities of a DMC will remain the same. Their primary responsibility will be to implement a pre-specified adaptation plan or decision criteria, and not to change the study design except for serious safety-related concerns. Nevertheless, compared to traditional data monitoring, some additional considerations are necessary for novel adaptive designs. They include monitoring of trials that have very complex decision criteria which may have major commercial implications, and monitoring of exploratory adaptive clinical trials.

Authors who are presenting talks have a * after their name.

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