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Abstract:
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Benefit-risk assessment (BRA) of a drug is important during both pre-approval and post marketing setting of clinical product development. In early 2018, FDA drafted PDUFA VI implementation plan and intends to investigate more on applying benefit risk assessment over the life cycle of clinical development. When treatments of a disease are available on the market already, it is often required to show that the new experimental drug has at least acceptable, and comparable or favorable benefit and risk profile over other existing drugs, in order to gain regulatory approval and market access. In this presentation, we proposed a framework to perform simultaneous benefit risk analysis for multiple treatments using network meta-analysis considering both between-treatment and between-endpoint correlations, combined with stochastic multicriteria acceptability analyses to evaluate and rank the benefit risk profile of multiple treatments. A real example is given to illustrate the usage and advantage of the proposed method.
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