Abstract

The application of multi-regional clinical trials (MRCTs) is a preferred strategy for rapid global new drug development. In a MRCT, besides the other subgroup factors that are in general well defined, region is a special subgroup factor which can be a surrogate of many intrinsic and extrinsic factors. The definition of a region for a MRCT may be trial specific. It depends on where the MRCT will be conducted and how the sample sizes will be allocated across the regions. As a regional health authority will carefully review the regional treatment effect before the approval of the drug for the patients of the region, special attention should be paid to the regional subgroup analysis. In this chapter, we will discuss subgroup analysis in design and analysis of multi-regional clinical trials focusing on regional subgroup analysis. These include the considerations on region definition, analysis model, consistency assessment of regional treatment effects, regional sample size allocation and trial result interpretation. Numerical and real trial examples will be used to illustrate the applications of the methods.

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