ABSTRACT
In this chapter, models for the statistical analysis of a multiregional clinical trial (MRCT) and the requisite sample sizes will be discussed. The model to be used for the analysis of the primary endpoint of an MRCT should be prespecified in the study protocol at the design stage. The trial design should be consistent with the proposed model (e.g., sample size calculation and design factors such as the number of regions). Clearly understanding the properties of statistical models in an MRCT setting will help us make an appropriate model selection and properly interpret the trial results.
