The Use of Bayesian Methods in FDA Applications: The Ghosts of Bayes Past, Present and Future

Music City Center 

The past decade has seen a steady increase in the number and variety of Bayesian approaches in drug and biologic development. Bayesian methods are now used to some degree in early and late phase trial design, pediatric drug development, subgroup analyses, pharmacovigilance, and non-clinical studies. In this talk, I will review the current state of Bayesian statistics in regulatory science, present case studies from a variety of applications, and discuss what the future of Bayesian methods might look like at FDA after the expected publication of a draft guidance document on the topic in September, 2025.