Conducting the non-inferiority test for the means with unknown coefficient of variation in a three-arm trial.

ABSTRACT:

Background

The non-inferiority test is a reasonable approach to assessing a new treatment in a three-arm trial. The three-arm trial consists of a placebo, reference, and an experimental treatment. The non-inferiority is often measured by the mean differences between the experimental and the placebo groups relative to the mean differences between the reference and the placebo groups.

Methods

To cope with possible estimation distortion due to the allowance of heteroskedasticity, we adjust the measurement of non-inferiority by the incorporation of coefficient of variation (CV) of the experimental, the reference and the placebo groups. In this research, we propose a generalized [Formula: see text]-value based method (GPV-based method) to facilitate non-inferiority tests for the

SUBMITTER: Lee MC 

PROVIDER: S-EPMC10422811 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature