Quantitative Benefit-Risk Assessments: Demonstration of Innovative Methods and Tools through a Case Study

Sai Dharmarajan Speaker
FDA
 
Monday, Aug 7: 2:45 PM - 3:05 PM
Topic-Contributed Paper Session 
Metro Toronto Convention Centre 
This talk will present a case study of how quantitative benefit-risk analysis can be used to inform drug approval decisions along with a description of methods and software that can be used. The focus will be on multiple criteria decision analysis (MCDA) and stochastic multi-criteria acceptability analysis (SMAA), two methods to quantify the aggregate performance of different alternatives across multiple benefits and risk endpoints, explicitly incorporating the relative importance of these endpoints. Starting with a description of the process of selecting endpoints and eliciting preferences the talk will provide an overview of how to conduct and present quantitative benefit risk analyses including examples of visual representations that can be used to summarize the results. Along the way, methods to incorporate prior data using mixture priors will also be discussed. The talk will end with a discussion of how the findings can be interpreted and briefly introduce an R Shiny tool that has been developed.