Structured Benefit-Risk Assessment Across the Lifecycle of Products: Methods, Examples, and Challenges

• Activity Number: 324
• Type: Contributed
• Date/Time: Tuesday, August 11, 2015 : 8:30 AM to 10:20 AM
• Sponsor: Biopharmaceutical Section
• Author(s): Chunlei Ke* and George Quartey and Christy Chuang-Stein and John Scott and Qi Jiang and Weili He and Ramin Aramin and Guochen Song and Kao-tai Tsai and Yujun Wu
• Companies: and Roche and Pfizer Inc. and FDA and Amgen and Merck and AstraZeneca and Quintiles and Celgene and Sanofi
• Keywords: Benefit-risk assessment ; drug development

Abstract

Benefit-risk assessment (BRA) is an integral part of drug development and evaluation with an aim to strengthen decision making for the benefit of public health. BRA was usually based on informal, qualitative weighing of benefits and risks. Recently there has been an increased interest in using structured benefit-risk assessments and also vast efforts from health authorities, industry, and academia to standardize, streamline and improve the BRA process. In this presentation, we report on some recent developments in qualitative and quantitative BRA. We also present some criteria and recommendations for evaluating BRA approaches, and provide several examples that can be used to discuss various aspects of BRA during product development.