Some Challenges in Structured Benefit-risk Assessment Across the Lifecycle of Products
*Chunlei Ke, Amgen 

Keywords: benefit-risk assessment, drug development, clinical trials

There has been increased interest in using structured benefit-risk assessment (BRA) in drug development, particularly following the release of draft benefit-risk (B-R) implementation plan by FDA in 2013. However, significant challenges have been recognized in implementing the benefit-risk assessment. The Quantitative Sciences in the Pharmaceutical Industry Benefit Risk Working Group (QSPI-BRWG) was established to promote the use of structured BRA and to improve BRA methodology. In this presentation, on behalf of the working group, we will discuss several important issues in BRA such as BRA methods, endpoint and weight selections, and heterogeneity. We will focus on quantitative methods and provide some considerations and recommendations, which will be illustrated with some real data examples.