Abstract Details
Activity Number:
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549
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Type:
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Contributed
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Date/Time:
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Wednesday, August 12, 2015 : 10:30 AM to 12:20 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #317153
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Title:
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Multiplicity Adjustment for Noninferiority Design
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Author(s):
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Jing Zhao*
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Companies:
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Merck Research Laboratories
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Keywords:
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multiplicity ;
non-inferiority
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Abstract:
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Noninferiority trials are intended to show that the effect of a new treatment is not worse than that of an active control by more than a specified margin. Based on a closed testing principle if the non-inferiority is established, the superiority can be further tested without inflation of the type I error. It is not necessary the case if there are multiple objectives (i.e. primary vs. secondary; multiple time periods, etc.) A simulation study is applied to show that the type I error will be inflated based on this situation.
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Authors who are presenting talks have a * after their name.
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