Uesaka Hiroyuki
The Center for Advanced Medical Engineering and Informatics, Osaka University, Osaka, Japan.
J Biopharm Stat. 2009 Jul;19(4):580-94. doi: 10.1080/10543400902963185.
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 between regional and overall results. Specifically, three rules of sample size allocation are discussed: (1) allocating equal size to all regions, (2) minimizing total sample size, and (3) minimizing the sample size of a specific region. Some total and regional sample sizes calculated under each allocation rule are illustrated.
多区域桥接试验的目的是证明一种药物在全球各个区域的疗效，同时评估将整体试验结果应用于每个区域的可能性。然而，要将整体结果应用于特定区域，该区域的结果应与整体结果或其他区域的结果一致。本文通过引入区域结果与整体结果一致性的统计标准，讨论了向各区域分配样本量的方法。具体而言，讨论了三种样本量分配规则：（1）给所有区域分配相等的样本量，（2）使总样本量最小化，（3）使特定区域的样本量最小化。文中举例说明了在每种分配规则下计算出的一些总样本量和区域样本量。
