An investigation of the constancy of effect in Cochrane systematic reviews in context with the assumptions for noninferiority trials.

ABSTRACT: When designing a noninferiority (NI) study one of the most important steps is to set the noninferiority (NI) limit. The NI limit is an acceptable loss of efficacy for a new investigative treatment compared to an active control treatment - often standard care. The limit should be a value so small that the loss efficacy is clinically zero. An approach to the setting of a noninferiority limit such that an effect over placebo can be shown through an indirect comparison to placebo-controlled trials where the active control treatment was compared to placebo. In this context, the setting of the NI limit depends on three assumptions: assay sensitivity, bias minimisation, and the constancy assumption. The last assumption of constancy assumes the effect of the active control over placebo is constant

SUBMITTER: Duro EM 

PROVIDER: S-EPMC9316704 | biostudies-literature | 2022 Jul

REPOSITORIES: biostudies-literature