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Activity Number: 113
Type: Topic Contributed
Date/Time: Monday, August 1, 2016 : 8:30 AM to 10:20 AM
Sponsor: Biopharmaceutical Section
Abstract #319324
Title: Example-Based Illustrations of Design, Conduct, Analysis, and Result Interpretation of Multi-Regional Clinical Trials
Author(s): Hui Quan* and Xuezhou Mao
Companies: Sanofi and Sanofi
Keywords: fixed and random effects models ; between-region variability ; consistency of treatment effects ; shrinkage estimate

Tremendous research has been conducted in the Multi-Regional Clinical Trial (MRCT) area. For effectively applying an appropriate approach to a MRCT, we need to synthesize and understand the features of different approaches. In this paper, examples are used to illustrate the design, conduct, analysis and result interpretation of MRCTs, and to compare different models and methods. We start with brief discussion of region definitions and the scenarios where different regions have different requirements for the MRCT. We then compare different designs and models as well as the corresponding result interpretation. We further highlight the importance of paying special attention to trial monitoring and conduct to prevent potential issues in the final trial results. Besides evaluating the overall treatment effect for the whole MRCT, we also consider other key analyses including quantification of regional treatment effects and assessment of consistency of regional treatment effects.

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

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