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In similarly designed clinical trials conducted in different regions or a multiregional trial, we sometimes observe different mean responses between trials or regions due to differences in distributions of an ethnic factor. Uesaka et al. ( 2003 ) used adjusted means for covariate, the distribution adjusted mean, to deal with such a situation. This paper… (More)
The objective of a multiregional bridging trial is to show the efficacy of a drug in various global regions, and at the same time to evaluate the possibility of applying the overall trial results to each region. However, to apply overall results to a specific region, the result in that region should be consistent with either the overall results or the… (More)