Department of Biostatistics Seminar/Workshop Series

Bayesian Adaptive Trials in Practice

Jason Connor, PhD

Berry Consultants

Wednesday, July 14, 1:30-2:30pm, MRBIII Conference Room 1220

I will describe Bayesian adaptive designs used in regulatory trials with pharmaceuticals companies and medical device makers. These include a range of prospective adaptations including adaptive selection of sample size, frequent updating of randomization probabilities, altering inclusion criteria to focus on patients in whom a therapy provides benefit, and adaptive seamless Phase 2/3 designs. I will illustrate two particular designs: a Phase 2 dose- finding trial incorporating adaptive randomization and a Phase 3 confirmatory trial using predictive probabilities and a longitudinal model updated throughout patient accrual to select the optimal sample size.