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Abstract:
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Benefit-risk assessment (BRA) of a pharmaceutical drug is a complex decision making process requiring evaluation of large amount of relevant data and balancing between the evidences for benefits and potential for harms. There are many challenging issues in BRA, among which it is critical to identify the most important benefits and also medically serious risks that drive the assessment (i.e. endpoint selection), weigh them properly for a fair comparison and to reflect their relative importance in the decision making, and quantify the uncertainty of the B-R evaluation. In this talk, we'd like to focus on these key aspects of BRA and share with you the points to consider put together by the QSPI BRWG on endpoint selection, weighting determination, and uncertainty evaluation, which consists members from across industry, FDA and academia. The challenges will be described and methods that could be used to address those challenges will be presented.
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