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One key objective of a multi‐regional clinical trial (MRCT) is to quantify country‐specific treatment effects to support local registration. Naïve estimate of the treatment effects based on country‐specific subsets of data are inefficient because of relatively sparse country‐specific sample sizes, even in large MRCTs, and subject to many limitations. The recently developed shrinkage estimate approach...
A key issue in multi‐regional clinical trials (MRCTs) is how to assess the consistency of treatment effect across regions, although there is no a priori reason to believe that the treatment effect should vary across the regions. In this article, we define the research question as an assessment of overall consistency across all regions for which all regions are considered equally important. This is...
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