Donald A. Berry, Ph.D.

New Developments in Bayesian Clinical Trials

Monday 6:00-7:00 P.M.

Abstract: The cover story of a recent Japanese pharmaceutical industry newsletter translated to “The Coming Bayesian Tsunami in Clinical Development.” I will give a brief history of the use of the Bayesian approach in clinical trials and describe the “earthquake” that gave rise to the tsunami, including where, how, and why it occurred. I’ll relay how the Bayesian approach is now being used in clinical trials, with special emphasis on its role in building adaptive designs. I’ll give a number of actual drug and medical device examples, including both trials funded by industry and by government. Finally, I’ll suggest where this is leading and how and when we’re going to get there.