Benefit-Risk Assessment in Drug Development
Benefit-risk assessment is a continuous process that informs key decisions across drug development stages. This session presents frameworks and methodologies for evaluating the therapeutic value of investigational products in relation to their potential risks. Quantitative and qualitative tools such as MCDA (Multi-Criteria Decision Analysis) and BRAT (Benefit-Risk Action Team) models are explored. Regulatory expectations for structured benefit-risk evaluations in clinical trial submissions and safety updates are discussed. Practical examples will highlight how sponsors use benefit-risk profiles to guide go/no-go decisions, optimize trial designs, and support regulatory approvals. Emphasis is also placed on communicating benefit-risk findings transparently to stakeholders, including patients and health authorities.
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