Benefit-Risk Assessment: A Brief Review and An Example of A Quantitative Approach
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*Zhong Yuan, Janssen Research & Development, LLC 

Keywords: Benefit-Risk assessment, quantitative approach, methods

While the notion that “benefits outweigh risks” has served as a basic principle in the drug approval process, there is no regulatory guidance for assessing benefit-risk (B-R) using quantitative methods. In a recent meeting hosted by the FDA, Dr. Jenkins presented the FDA’s perspective on B-R evaluation. Five areas were identified: Severity of condition, Unmet medical need, Clinical benefit, Risk, and Risk management. Interestingly, B-R methodologies, whenever applied, may vary considerably across different settings. In this talk, several B-R measures will be reviewed. In addition, a comprehensive B-R assessment approach will be applied to a clinical development program to quantify B-R. Finally, we show an example of taking patients’ perspective into account for evaluating B-R, an aspect in line with the FDA PDUFA V initiative for a structured B-R assessment in new drug approval process.