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Abstract Details
Activity Number:
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183
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Type:
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Contributed
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Date/Time:
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Monday, August 1, 2011 : 10:30 AM to 12:20 PM
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Sponsor:
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International Chinese Statistical Association
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Abstract - #301238 |
Title:
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Noninferiority and Superiority Tests for Multiple Immunogenicity Endpoints in Vaccine Clinical Studies
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Author(s):
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Lihan Yan*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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, , MD, ,
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Keywords:
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non-inferiority ;
superiority ;
multiple endpoints ;
vaccine ;
type I error
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Abstract:
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Non-inferiority and superiority of a new vaccine to an existing one in terms of immunogenicity in a vaccine study often involves multiple endpoints corresponding to multiple strains or serotypes. The statistical hypothesis is often constructed as an intersection-union test among multiple endpoints, which allows the hypothesis test to be done for each endpoint at the desired overall Type I error rate with the overall rate being still conservatively preserved. Following the closed testing principle, the Type I error for the superiority test performed subsequently to the non-inferiority test is also controlled without further adjustment. It is not uncommon that the investigators weigh in on success of a trial by individual hypothesis test results and make a declaration even though the success criterion constrained by the hypothesis is not met. This presentation explores the impacts on the Type I error rate control from a variety of scenarios where the claims are made deviating from the decision rule indicated by the hypothesis testing. These results may serve as a potential reference for the investigators as to cautions as well as levels of comfort during decision making.
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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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