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Activity Number:
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145
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Type:
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Contributed
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Date/Time:
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Monday, July 30, 2007 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #310346 |
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Title:
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Trials and Tribulations in Choosing Noninferiority Margins
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Author(s):
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John Johnson*+
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Companies:
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Cato Research, Ltd.
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Address:
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4364 South Alston Avenue, Durham, NC, 27713-2280,
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Keywords:
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noninferiority trials ; margins ; clinical trials
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Abstract:
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The choice of noninferiority margin in clinical trials is under greater scrutiny, but scant guidance is provided from regulatory agencies and the literature on just how to justify the margin. For example, regulatory guidance with specific advice have been withdrawn, and sponsors of trials have been called upon to write more specific justifications in their protocols. Some difficulties encountered during a recent case are presented, along with a discussion of how they were handled.
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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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