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Activity Number:
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367
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 9, 2006 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #307528 |
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Title:
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Adaptive Dose-Response Phase II Trials for Clinical Development
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Author(s):
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Qing Liu*+
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Companies:
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Johnson & Johnson
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Address:
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25 Wellington Drive, Long Valley, NJ, 07853,
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Keywords:
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adaptive designs ; dose-response trials ; multiple-trend tests
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Abstract:
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We propose a two-stage adaptive dose-response design for phase II clinical trials. A primary objective is to demonstrate that, within the dose-range, there is a positive trend toward better efficacy for higher doses. A secondary objective is to select the lowest dose for phase III trials. To increase the efficiency and protect patient's safety, the design allows addition or deletion of doses in the second stage upon knowledge of the efficacy and safety dose-response relationships at the interim analysis. Once the doses are selected for the second stage, the sample size for the second stage also is calculated. The design is suitable for applications where the efficacy endpoint is not immediately assessable.
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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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