DMCS and Benefit:Risk Assessment

• Activity Number: 570 - More Emerging Topics in Benefit-Risk Assessment in Clinical Development Decision Making
• Type: Topic Contributed
• Date/Time: Wednesday, August 2, 2017 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Scott Evans* and Christy Chuang-Stein and Dave DeMets and Paul Gallo and Weili He and Qi Jiang and Frank Rockhold
• Companies: Harvard University and Retired! and Retired and Novartis and Merck & Co., Inc. and Amgen Inc. and Retired
• Keywords: DMC ; Benefit:risk

Abstract

A primary role of DMCs is to conduct benefit:risk assessment. In practice, assessment is often suboptimal. Challenges limiting the effectiveness of DMC benefit:risk evaluation include restricted access to important data, ineffective DMC reports, insufficient adverse event characterizations, and failure to adhere to the intent-to-treat principle. We provide updates from QSPI's DMC Benefit:risk Working Group on the development of guidelines to address these challenges for improved DMC benefit:risk assessment.