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Activity Number: 341 - Topics in Adaptive Designs: Sample Size, Randomization and Related Topics
Type: Contributed
Date/Time: Wednesday, August 5, 2020 : 10:00 AM to 2:00 PM
Sponsor: Biopharmaceutical Section
Abstract #312879
Title: Statistical Considerations of Data Transformation in Non-Inferiority Testing
Author(s): Ran Bi* and Yi Tsong
Companies: FDA/HHS and FDA/HHS
Keywords: Non-Inferiority; Data Transformation; Non-Parametric
Abstract:

In clinical trial, a test treatment is often compared with a reference treatment for non-inferiority or equivalence. The comparison is often carried out by comparing the difference or ratio of treatment means against a constant non-inferiority margin. For continuous endpoints, the data is often assumed to be normally distributed. In a superiority test setting, when the normality assumption is violated, we may use a non-parametric method or data transformation strategy to carry out some proper tests. However, with the non-inferiority test setting, we may encounter difficulties when carrying out the proper test. We will illustrate the problems with some examples.


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

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