Communication, Confidentiality, and Oversight Issues for DMCs in 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): Paul Gallo*+
• Companies: Novartis
• Keywords: DMC ; adaptive trial ; interim analysis

Abstract

Recent evolution in DMC responsibilities, such as recommending changes to a trial within the scope of a valid adaptive design, raises new challenges for implementing effective DMC operational models which achieve the interim monitoring objectives while maintaining trial integrity. Important issues which must be considered include identification of personnel who are optimally qualified to make the potentially more complex judgments that may be required, and whether single or separate monitoring boards should make different types of recommendations that might be part of the monitoring plan. Communication among the various stakeholders involved, including the study sponsor, must be carefully controlled and implemented to meet the needs of all parties, and detailed pre-planning becomes critical. We additionally discuss potential implications of operational models for DMC oversight boards which have recently been proposed.