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Abstract Details
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Activity Number:
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564
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2011 : 2:00 PM to 3:50 PM
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Sponsor:
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Biometrics Section
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| Abstract - #300536 |
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Title:
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Methods for Determination of Noninferiority Margin
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Author(s):
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H.M. James Hung*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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10903 New Hampshire Avenue, Silver Spring, MD, 20993-0002,
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Keywords:
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non-inferiority margin ;
active control
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Abstract:
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The FDA non-inferiority draft guidance lays out a fundamental framework for design consideration in planning a non-inferiority trial or more broadly an active control trial. A key design specification in that framework is non-inferiority margin. The guidance contains a number of case examples showing margin determination under different scenarios. The statistical literature contains a number of methods for determining the margin. This presentation will shed some insights into the essential considerations behind these methods. A new method will be introduced for discussion.
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