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Abstract Details
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Activity Number:
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116
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Type:
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Topic Contributed
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Date/Time:
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Monday, August 1, 2011 : 8:30 AM to 10:20 AM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #301604 |
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Title:
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Elicitation of Noninferiority Margin
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Author(s):
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Xiting "Cindy" Yang*+
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Companies:
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U.S. Food and Drug Administration/CDRH
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Address:
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10903 New Hampshire Avenue , Silver Spring, MD, 20993,
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Keywords:
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elicitation ;
non-inferiority ;
device trial
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Abstract:
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In designing and analyzing non-inferiority trials, the choice of a non-inferiority margin always plays an important role in affecting trial characteristics. With little tool in use, such choice many times falls on the sample size determination and introduces many biases and difficulties in interpreting trial results. In this talk, using elicitation to systematically obtain a proper non-inferiority margin to help facilitate communication is discussed.
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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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