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Activity Number: 427
Type: Contributed
Date/Time: Tuesday, August 6, 2013 : 2:00 PM to 3:50 PM
Sponsor: Biopharmaceutical Section
Abstract - #309134
Title: Assessing Consistent Treatment Effect Under a Discrete Random Effect Model in a Multiregional Clinical Trial
Author(s): Hsiao-Hui Tsou*+ and Jung-Tzu Liu and Chi-Tian Chen and Yi-Hsuan Lai and Wan-Jung Chang and Chinfu Hsiao and Gordon Lan
Companies: National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and National Health Research Institutes and Janssen Pharmaceutical Companies of Johnson & Johnson
Keywords: multiregional clinical trial ; discrete random effect model ; consistency
Abstract:

In recent years, developing pharmaceutical products via a multiregional clinical trial (MRCT) has become very popular. Traditionally, an MRCT would assume a fixed effects model. However, heterogeneity among regions may have impact upon a medicine's effect. In this study, we consider a random effect model using discrete priors (DREM) to account for heterogeneous treatment effect across regions for the design and evaluation of MRCTs. We use the consistency criterion of Method 1 from the Japanese Ministry of Health, Labour and Welfare (MHLW) guidance to assess whether the overall results from the MRCT can be applied to a region of interest under DREM after showing the overall efficacy of a drug in all global regions. In addition, we use criterion of Method 2 from the Japanese MHLW guidance to assess whether there is a consistent trend across regions under DREM. We further address consideration on the sample size required for the region of interest or sample size allocation for each region based on the established criteria. Numerical examples are given to illustrate applications of the proposed approach.


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