131 – Topics in Clinical Trials
Estimation of Treatment Effect in a Multi-Regional Clinical Trial With Survival Endpoint
Yu-Chieh Cheng
National Health Research Institutes
Chin-Fu Hsiao
National Health Research Institutes
Ya-Ting Hsu
National Health Research Institutes
Fang-Jing Lee
National Health Research Institutes
Eric Slud
University of Maryland College Park and U.S. Census Bureau
Hsiao-Hui Tsou
National Health Research Institutes and China Medical University
Hsiao-Yu Wu
National Health Research Institutes
Yuh-Jeng Wu
Chung Yuan Christian University
Multiregional clinical trial (MRCT) has become a popular strategy in the development of new medicines. By incorporating subjects from many regions under a single protocol, an MRCT seeks regulatory approval for all participating regions. Therefore, the first goal in an MRCT is to show the overall treatment efficacy of the new therapy. In this presentation, we focus on the design and analysis of a two-arm comparative multiregional clinical trial with survival endpoint. We provide a statistical model to combine regional treatment effects for estimation of overall treatment effect. ICH E17 guidance provides some approaches to sample-size allocation in an MRCT. Thus, we evaluate those approaches by numerical examples in the presentation. The evidence of consistency in treatment effects among regions is usually required for regional approval. We further explore how to evaluate consistency in treatment effects among regions and how to make inferences of the treatment effect for a specific region.