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Activity Number:
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23
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Type:
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Contributed
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Date/Time:
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Sunday, August 11, 2002 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section*
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| Abstract - #301136 |
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Title:
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Bridging Studies: Design and Analysis Issues
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Author(s):
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Cynthia Siu*+ and Isma Benattia and Kuang-Kuo Lan and Guy Cohen
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Affiliation(s):
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Pfizer, Inc. and Pfizer, Inc. and Pfizer, Inc. and Pfizer, Inc.
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Address:
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235 East 42nd Street, NY, New York, 10017-5755, US
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Keywords:
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Bridging studies ; sample size selection ; design ; analysis ; data comparability ; error rates
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Abstract:
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ICH E-5 Guideline describes the use of bridging study to allow extrapolation of foreign clinical data to a new region. The goal is to facilitate the acceptance of foreign data to minimize duplication of clinical studies and expedite the availability of new therapies to patients for their benefit. The type of bridging study required depends on experience with the drug class and extrinsic factors like medical practice. In this paper, we describe an approach of selecting sample size for a bridging study that duplicates the design of a large trial successfully completed outside the region. Reduced sample size is proposed to show comparability of results in different ethnic populations. This is accomplished by adopting relaxed criteria for Type I and Type II error rates in sample size calculations. The impact of the proposed design on the analyses and interpretations of bridging studies, and sensitivity of results to intrinsic and extrinsic ethnic factors, will be discussed.
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