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Abstract Details
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 - #301358 |
Title:
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Noninferiority Tests for Binomial Endpoints in Two-Arm Medical Device Trials
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Author(s):
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Maria Carola Alfaro*+ and Edmund McMullen
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Companies:
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Boston Scientific Corporation and Boston Scientific Corporation
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Address:
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4100 Hamline Avenue North, Saint Paul, MN, 55112-5798,
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Keywords:
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Non-inferiority ;
binomial ;
sample size ;
type I error ;
power
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Abstract:
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Non-inferiority testing is performed in trials that intend to show that the new device is not inferior to the standard device. A non-inferiority test can be done on binomial and continuous endpoints. Our focus will be non-inferiority tests for the difference of binomial primary endpoints rates in two-sample trials. In this scenario a non-inferiority test is a one-sided test based on the binomial distribution. This test has impact on the sample size, type I error, power and non-inferiority margin of the trial in the design stage, and the conclusion of this test is based on the calculated one-sided p-value of the primary endpoint data. Through real case examples, we will analyze the impact of using different non-inferiority tests in the design stage and on the primary endpoint data through a comparison of estimations of sample size, type I error, power, non-inferiority margin and p-values.
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