Abstract:
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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.
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