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Abstract:
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Multiregional clinical trials are commonly conducted for registration of a new drug in various countries. The advantages of multiregional clinical trials may be the overall efficiency, including the speed, cost reduction, and better generalization of the results. However, it may not always be clear how to design or evaluate such multiregional clinical trial data, nor what evidence would have to be shown to the regulatory agency in a country or region. Particular issues to be considered include differences in ethnicity, medical practice, patient population, and dose regimen; number of subjects needed in each country or region; method of analysis of "by-country" or "by-region" data; and interpretation of overall and "by-country" or "by-region" data. Although there may not be a gold standard statistical approach to these issues, there are a number one can adopt.
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