Statistical methods in recent HIV noninferiority trials: reanalysis of 11 trials.

ABSTRACT:

Background

In recent years the "noninferiority" trial has emerged as the new standard design for HIV drug development among antiretroviral patients often with a primary endpoint based on the difference in success rates between the two treatment groups. Different statistical methods have been introduced to provide confidence intervals for that difference. The main objective is to investigate whether the choice of the statistical method changes the conclusion of the trials.

Methods

We presented 11 trials published in 2010 using a difference in proportions as the primary endpoint. In these trials, 5 different statistical methods have been used to estimate such confidence intervals. The five methods are described and applied to data from the 11 trials. The noninferiority of the

SUBMITTER: Flandre P 

PROVIDER: S-EPMC3168436 | biostudies-literature | 2011

REPOSITORIES: biostudies-literature