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Activity Number: 549
Type: Contributed
Date/Time: Wednesday, August 12, 2015 : 10:30 AM to 12:20 PM
Sponsor: Biopharmaceutical Section
Abstract #317153
Title: Multiplicity Adjustment for Noninferiority Design
Author(s): Jing Zhao*
Companies: Merck Research Laboratories
Keywords: multiplicity ; non-inferiority
Abstract:

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.


Authors who are presenting talks have a * after their name.

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