Abstract
Current statistical design and analysis of multiregional clinical trials for medical devices generally follows a paradigm where the treatment effect of interest is assumed consistent among US and OUS regions. In this paper, we discuss the situations where the treatment effect might vary among US and OUS regions, and propose a two-component Bayesian approach for targeted decision making. In this approach, anticipated treatment difference among US and OUS regions is formally taken into account by design, hopefully leading to increased transparency and predictability of targeted decision making.
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