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Activity Number:
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547
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Type:
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Topic Contributed
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Date/Time:
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Thursday, August 6, 2009 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #305295 |
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Title:
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Considerations on Criteria for Consistency Across Regions in Multi-Regional Trials
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Author(s):
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Kimitoshi Ikeda*+
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Companies:
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Novartis Pharma K.K.
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Address:
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4-17-30, Nishi-Azabu, Minato-ku, Tokyo, 106-8618, Japan
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Keywords:
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consistency ; Japanese sample size ; interaction
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Abstract:
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A multi-regional trial has at least two main objectives. First, it is necessary to show a significant benefit in effect of a new drug over placebo in the entire study population. Second, one needs to demonstrate that the results for a particular region are consistent with those from the entire population. We discuss critically the methods shown in a regulatory guidance document on global trials recently issued in Japan to calculate the required sample size for the Japanese subpopulation in multi-regional clinical trials. In addition, we consider criteria for consistency from two perspectives---the effect in a particular region and the region-by-treatment interaction---and we propose improved methods with better operating characteristics than the current approaches.
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- The address information is for the authors that have a + after their name.
- Authors who are presenting talks have a * after their name.
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