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Abstract:
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According to ICH, data from an existing study may be extrapolated to a new study, in a new region utilizing a different dose, if the safety and efficacy profiles are not substantially different. One of the main challenges of this type of study, based on foreign clinical trials, is the difference in sample sizes. Specifically, the Global data, which is frequently the original data in such studies, regularly contains a much larger sample size than its Asian (or local) counterpart. In order to study the similarity of a drug response in the two ethnic populations, we investigate resampling techniques to overcome the size disparity between the data sets, while utilizing a general linear model to adjust the fundamental differences between the two populations, with respect to some important covariates. We provide an example of their utility based on clinical trials of raloxifene.
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