Dr. Telba Irony
Deputy Director, Office of Biostatistics and Epidemiology
Center for Biologics Evaluation and Research
Food and Drug Administration
Title: The Value of Bayesian Approaches in the Regulatory Setting: Lessons from the Past and Perspectives for the Future
The use of Bayesian approaches for the regulation of medical products has been advocated for the past 20 years, but its rather limited implementation in the US could be expanded. The emerging importance of benefit-risk determinations to inform the approval of medical products presents an exceptional opportunity to advance the use of Bayesian methods because they are uniquely suitable for decision making. While the main challenge of benefit-risk determinations for medical product approval is to combine information with values, the essence of the Bayesian approach is to collect data and update information to merge it with stakeholder values for rational decision making.
In this DIA-BSWG session we will discuss lessons learned from the use of Bayesian approaches for the regulation of medical devices, explaining what has worked and what has not worked, aiming to advance the use of Bayesian methods for the regulation of medical products in general.
We will argue that the use of Bayesian approaches in the regulation of medical products will have its highest value when combined with Decision Analysis where patient preferences and the context in which the medical product is evaluated are considered and integrated into the process.