General Considerations for Data Monitoring of Adaptive Trials

• Activity Number: 228
• Type: Topic Contributed
• Date/Time: Monday, August 5, 2013 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Zoran Antonijevic*+
• Companies: Cytel
• Keywords: DMC ; Adaptive Trials ; Roles ; Responsibilities ; Membership ; Communication

Abstract

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.