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Abstract:
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An effective benefit-risk assessment is critical in both drug development and regulatory decision making, from early phase development of medical products to medical reimbursement to payers. Benefit-risk analysis (BRA) is a systematic and holistic process that requires both qualitative and quantitative assessment during the whole drug development. Despite the importance of quantitative BRA, the appropriate quantitative methodologies and their real applications are sparse, and there are no general agreement on what analytical methods should be used. In this roundtable discussion, we are going to discuss the emergent issues in benefit-risk assessment, the statistical methods such as MCDA/SMAA, and the practical experience of BRA.
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