Sample size allocation to regions in a multiregional trial.

@article{Uesaka2009SampleSA,
  title={Sample size allocation to regions in a multiregional trial.},
  author={Hiroyuki Uesaka},
  journal={Journal of biopharmaceutical statistics},
  year={2009},
  volume={19 4},
  pages={580-94}
}
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 results of other regions. This article discusses methods of sample size allocation to regions by introducing statistical criteria for consistency… CONTINUE READING