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Activity Number: 131 - Topics in Clinical Trials
Type: Contributed
Date/Time: Monday, July 29, 2019 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #306457
Title: Estimation of Treatment Effect in a Multi-Regional Clinical Trial with Survival Endpoint
Author(s): Hsiao-Hui Tsou* and Yu-Chieh Cheng and Yuh-Jeng Wu and Chin-Fu Hsiao
Companies: National Health Research Institutes and National Health Research Institutes and Chung Yuan Christian University and National Health Research Institutes
Keywords: Multiregional clinical trials; survival endpoint; overall treatment effect; sample-size allocation; consistency

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.

Authors who are presenting talks have a * after their name.

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