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Abstract:
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Multiregional clinical trials (MRCT) have become more and more popular in global clinical development across many therapeutic and disease areas such as Alzheimer's disease. There has been a lot of research on evaluation of the consistency of treatment effects among regions. However, less attention has been placed on the scenarios that 1) even though the between group treatment differences are consistent across regions, there could be some small but non-ignorable difference in baseline characteristics in patient populations; or 2) even though the treatment group differences are similar across regions, within each group the treatment effects may vary from region to region. Both situations could occur due to variations in patient populations, culture, medical practice or standard of care. In this research, the impact of these two types of variations on the Type I error and power of the study will be evaluated. Based on the results of this assessment, the recommendation to conduct MRCT or separate within-region trials will be made when such discrepancies are expected.
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