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Activity Number:
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14
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 3, 2008 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301493 |
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Title:
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Simulated Sample Size Required for a Geographical Region Relative to a Global Study in a Medical Device Trial
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Author(s):
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Jian Huang*+ and Haiying Lin and Yukiko Imai
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation and Boston Scientific Corporation
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Address:
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4100 Hamline Avenue North, St. Paul, MN, 55112,
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Keywords:
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Global trials ; Sample Size ; Simulation ; Superiority ; Non-inferiority
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Abstract:
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The International Conference on Harmonisation (ICH - E5, 1998) provides the guidance on Ethnic Factors in the Acceptability of Foreign Clinical Data to minimize the duplication of clinical data and to allow for the extrapolation of those data to 'New regions.' For a global medical device trial, it is necessary to select the appropriate sample size for the regions. There is no well established method for region sample-size determination. In this presentation, the simulation method is proposed for evaluating the approaches recommended by Japan Pharmaceuticals and Medical Devices Agency (PMDA). A superiority and noninferiority design are discussed. Consistency across multiple regions is also examined.
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