Bayesian and Decision Analysis Approaches for Regulation of Medical Products
*Telba Irony, FDA 


Benefit-risk assessments for medical products involve all available information about the benefits and risks of a treatment that can be obtained through clinical trials and real world data. While the main challenge of benefit-risk determinations for regulation of medical product is to combine information with values, the essence of the Bayesian approach is to collect and update information, and merge it with values to make rational decisions. In this talk I will discuss and provide examples of how the Bayesian approach can provide a framework for decision making and benefit-risk determinations of medical products.