delete these guides from slide master before printing or giving to the client 1 Bayesian Trial Design – Case studies Panelists Andrew Mugglin, Medtronic Don Berry, MD Anderson Michael Krams, Pfizer Stacy Lindborg, Eli Lilly Suman Bhattacharya, Biogen Idec Telba Irony, FDA-CDRH 2005 FDA/Industry Workshop

delete these guides from slide master before printing or giving to the client 2 Questions to the Panel 2005 FDA/Industry Workshop Introduction How have you been involved with Bayesian Clinical Trials?

delete these guides from slide master before printing or giving to the client 3 1) In what kinds of clinical trial is it advantageous to be Bayesian? How does one make the determination that using a Bayesian design is worthwhile? 2005 FDA/Industry Workshop

delete these guides from slide master before printing or giving to the client 4 2) What challenges should one expect when implementing a Bayesian trial? (Including non-statistical and practical challenges) 2005 FDA/Industry Workshop

delete these guides from slide master before printing or giving to the client 5 3) Are there any therapeutic areas in drug development where the Bayesian approach may be more advantageous and ethical than the traditional approach? 3a) To what stage of drug development are Bayesian methods most suited? 3b) Are there examples of clinical trials where Bayesian methods may not be appropriate? 3c) What sort of Bayesian design and analysis is most likely to win regulatory acceptance in the drug world? 2005 FDA/Industry Workshop

delete these guides from slide master before printing or giving to the client 6 4) Should Type-1 error rates and frequentist operating characteristics be the standard by which Bayesian designs are judged? 2005 FDA/Industry Workshop

delete these guides from slide master before printing or giving to the client 7 Thank you Luncheon Round Tables 2005 FDA/Industry Workshop