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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 - #301382 |
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Title:
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Practical Issues in Noninferiority Trials
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Author(s):
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Chul H. Ahn*+
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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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non-inferiority ;
superiority ;
non-inferiority margin ;
device trial ;
data quality ;
significance level
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Abstract:
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Non-inferiority trials are not simply underpowered superiority trials. In general, non-inferiority trials are more challenging to design, conduct and interpret. This talk will address some of the practical issues with non-inferiority trials such as selection of non-inferiority margin, sample size, significance level, testing for both superiority and non-inferiority, and data quality among others. Some specific examples of non-inferiority device trials will also be presented.
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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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