An empirical Bayes approach to evaluation of results for a specific region in multiregional clinical trials

Yufen Huang, Wan Jung Chang, Chin Fu Hsiao

研究成果: Article同行評審

5 引文 斯高帕斯(Scopus)

摘要

To accelerate the drug development process and shorten approval time, the design of multiregional clinical trials (MRCTs) incorporates subjects from many countries/regions around the world under the same protocol. After showing the overall efficacy of a drug in all global regions, one can also simultaneously evaluate the possibility of applying the overall trial results to all regions and subsequently support drug registration in each of them. In this paper, we focus on a specific region and establish a statistical criterion to assess the consistency between the specific region and overall results in an MRCT. More specifically, we treat each region in an MRCT as an independent clinical trial, and each perhaps has different treatment effect. We then construct the empirical prior information for the treatment effect for the specific region on the basis of all of the observed data from other regions. We will conclude similarity between the specific region and all regions if the posterior probability of deriving a positive treatment effect in the specific region is large, say 80%. Numerical examples illustrate applications of the proposed approach in different scenarios.

原文English
頁(從 - 到)59-64
頁數6
期刊Pharmaceutical Statistics
12
發行號2
DOIs
出版狀態Published - 2013 三月

All Science Journal Classification (ASJC) codes

  • 統計與概率
  • 藥理
  • 藥學(醫學)

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