Online Program

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All Times EDT

Wednesday, September 23
Wed, Sep 23, 11:30 AM - 12:45 PM
Virtual
Benefit-Risk Analysis and Endpoint Studies in Clinical Trials

Case Study of Multiple Criteria Decision Analysis for Quantitative Benefit Risk Assessment (301270)

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*Sai Dharmarajan, FDA 

Keywords: benefit-risk, MCDA

This talk will present a case study of a quantitative benefit-risk analysis of an anti-platelet agent for primary prevention of cardiovascular events. The talk will show how multiple criteria decision analysis (MCDA) can be used to quantify the aggregate performance of different alternatives across multiple benefits and risk endpoints, explicitly incorporating the relative importance of these endpoints. A description of the process by which endpoints were selected and weighted relative to each other will be provided along with examples of visual representations that can be used to summarize the results including some that incorporate uncertainty around the endpoints. Finally, a discussion of how the findings from MCDA can be interpreted will be provided.