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Activity Number:
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166
- Non-Clinical Statistics, Personalized Medicine, and Other Topics
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Type:
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Contributed
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Date/Time:
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Tuesday, August 10, 2021 : 10:00 AM to 11:50 AM
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Sponsor:
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Biopharmaceutical Section
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Abstract #318510
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Title:
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Comparing the Means of Continuous Measurements for Noninferiority and Equivalence
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Author(s):
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Shaobo Liu* and Xiaoyu Cai and Meiyu Shen and Yi Tsong
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Companies:
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U.S. Food and Drug Administration and U.S. Food and Drug Administration and Office of Biostatistics CDER, FDA and CDER, US FDA
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Keywords:
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Mean test;
Median test;
Noninferiority test;
Equivalence test;
Bootstraping;
Permutation
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Abstract:
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When comparing the means of normally distributed endpoint of two drug products, t-test is used as a standard procedure. When the data fail the normality assumption, but the sample sizes are sufficiently large, a large sample z-test is used. However, when the sample size is small, the conventional non-parametric approaches such as median test, tests based on the rank or tests based on transformed data that are applicable to test for superiority may not be able to be applicable to non-inferiority or equivalence hypothesis with a non-zero margin set for mean difference. In this presentation, we discuss the difficulties of applying median and rank test for such hypothesis. We further discuss the potential application of bootstrapping and permutation tests.
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Authors who are presenting talks have a * after their name.
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