DMC Decision-Making: Behind Closed Doors

• Activity Number: 474
• Type: Invited
• Date/Time: Wednesday, August 12, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): John M. Lachin* and Catherine M. Tangen* and KyungMann Kim* and Stephen L. George*
• Companies: The George Washington University and Fred Hutchinson Cancer Research Center and University of Wisconsin - Madison and Duke University
• Keywords: DMC ; DSMB ; clinical trial ; clinical study ; monitoring ; closed session

Abstract

Data Monitoring Committees (DMCs) meet throughout a clinical study to help protect the safety of study participants, the credibility of the study and the validity of study results. Many industry statisticians interact with DMCs but don't participate in the Closed Session where the DMC discusses study results by treatment arm. This panel discussion goes 'behind the scenes'. Experienced DMC statisticians will talk about how the DMC arrives at recommendations. Potential topics include 1) what reports are most useful to the DMC, 2) how safety and efficacy are weighed against each other, 3) how the statistician on the DMC interacts with clinical members of the DMC, 4) how much of decision making is statistical vs. clinical experience, 5) how thorough is review of materials before and during closed session, 6) evaluation of study conduct or performance issues or ethical considerations unrelated to safety, 7) how voting or consensus is achieved, 8) what can be done to improve the DMC process, 9) the role of the DMC in re-designing a study, and 10) real-life examples from completed studies.