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Activity Number:
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528
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Type:
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Contributed
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Date/Time:
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Wednesday, August 5, 2009 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #304725 |
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Title:
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Determination of Sample Size in Multi-Regional Clinical Trials
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Author(s):
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Feng-shou Ko*+ and Hsiao-hui Tsou and Chin-fu Hsiao
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Companies:
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National Health Research Institutes and National Health Research Institutes and National Health Research Institutes
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Address:
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, , ,
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Keywords:
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global trial ; random effect model ; sample size
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Abstract:
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A multi-regional trial can shorten the drug lag or the time lag for approval and enhance drug development. The 11th Q&A for the ICH E5 guideline discusses the concept of a multi-regional trial. Kawai et al. (2008) proposed the method to determine the sample size in each region for a multi-regional trial. They assumed that the effect size is uniform across the regions. However, it is not reasonable in a clinical trial study. In our proposed method, the random effect model is employed to construct the testing hypothesis for the calculation of the total sample size and allows the heterogeneous effect size among regions in a multi-region trial. We explore how the proportion of the sample size in each region influences on the total sample size in a multi-regional clinical trial. Our method is more practicable to determine the sample size in each region for a multi-regional trial.
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