All Times EDT
Keywords: clinical trials, bayesian methods, regulatory science
After many years of skepticism, the application of Bayesian approaches to drug and biologics regulation has recently undergone a renaissance. Bayesian methods are now seen with increasing frequency in adaptive designs, rare diseases, pediatrics, master protocols, subgroup analyses, and real world and postmarket settings, among other areas. In this talk, I'll briefly review the history of Bayesian methodologies in regulatory applications, discuss some specific examples, and speculate about what the future holds for Bayes.