Simultaneous confidence intervals for an extended Koch-Rohmel design in three-arm non-inferiority trials.

ABSTRACT: Three-arm 'gold-standard' non-inferiority trials are recommended for indications where only unstable reference treatments are available and the use of a placebo group can be justified ethically. For such trials, several study designs have been suggested that use the placebo group for testing 'assay sensitivity', that is, the ability of the trial to replicate efficacy. Should the reference fail in the given trial, then non-inferiority could also be shown with an ineffective experimental treatment and hence becomes useless. In this article, we extend the so-called Koch-Röhmel design where a proof of efficacy for the experimental treatment is required in order to qualify for the non-inferiority test. While the efficacy of the experimental treatment is an indication of assay sensitivity, it do

SUBMITTER: Scharpenberg M 

PROVIDER: S-EPMC10540495 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature