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Activity Number:
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16
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Type:
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Topic Contributed
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Date/Time:
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Sunday, July 29, 2007 : 2:00 PM to 3:50 PM
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Sponsor:
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ENAR
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| Abstract - #309905 |
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Title:
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Sample Size Determination of Japanese Patients for Multiregional Clinical Trial in Oncology
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Author(s):
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Risa Sekiguchi*+ and Sachio Ogawa and Hiroyuki Uesaka
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Companies:
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Eli Lilly and Company and Eli Lilly and Company and Eli Lilly and Company
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Address:
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Sannomiya Plaza Bldg 7 1 5, Kobe, 651-0086, Japan
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Keywords:
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hazard ratio ; multi-regional clinical trial ; oncology ; sample size
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Abstract:
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Recently, the pharmaceutical companies in Japan tend to join multiregional clinical trials in order to achieve a simultaneous submission globally. One of the critical issues in the design of a multi-regional trial is sample size determination of Japanese patients. It is not feasible to take account of statistical significance of efficacy in Japanese patients when we estimate the sample size of Japanese patients. It will be preferable to estimate the sample size of Japanese patients so that we can show that the effect size in Japanese patients is bigger than by the specified fraction of the effect size in the whole or in the patients other than Japan at least. We will present the example of how to estimate sample size of Japanese patients in multiregional clinical trial in oncology from this point of view.
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