Online Program Home
My Program

Abstract Details

Activity Number: 75
Type: Contributed
Date/Time: Sunday, July 31, 2016 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #320067
Title: Use of Bayesian Approach for the Design and Evaluation of Multiregional Clinical Trials
Author(s): Chinfu Hsiao* and Yu-Chieh Cheng and Hsiuying Wang
Companies: National Health Research Institutes and National Chiao Tung University and National Chiao Tung University
Keywords: Multi-regional clinical trial ; Bayesian approach ; ethnic difference

To speed up drug development to allow faster access to medicines for patients globally, conducting multi-regional trials incorporating subjects from many countries around the world under the same protocol may be desired. Several statistical methods have been purposed for the design and evaluation of multi-regional trials. For the conduct of multiregional clinical trials, it might be expected that there is a difference in treatment effect due to regional difference (e.g., ethnic difference). Therefore, we propose to use a Bayesian approach to design and evaluation of MRCTs under normality. We will assume that there is a difference in treatment effect due to regional difference. However the population variance is assumed to be equal and known. Methods for sample size determination for the multi-regional clinical trial are also proposed.

Authors who are presenting talks have a * after their name.

Back to the full JSM 2016 program

Copyright © American Statistical Association