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Abstract:
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In recent years, developing pharmaceutical products via a multiregional clinical trial (MRCT) has become more popular. Many studies with proposals on design and evaluation of MRCTs under the assumption of a common treatment effect across regions have been reported in the literature. However, heterogeneity among regions causes concern that the fixed effects model for combining information may not be appropriate for MRCT. In this presentation, we will discuss: 1. The use of the fixed effect model, the continuous random effect model, and the discrete random effect model for the design and data analysis of MRCTs. Numerical examples will be provided to illustrate the fundamental differences among these three models. 2. Consistency and inconsistency: We will provide examples of inconsistency, and discuss the use of drop-min data analysis when the region with minimum treatment effect is excluded from the MRCT. We provide a solution first formulated within the fixed effects framework, and then extend it to discrete random effect models.
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