Determining a Bayesian predictive power stopping rule for futility in a non-inferiority trial with binary outcomes.

ABSTRACT:

Background/aims

Non-inferiority trials investigate whether a novel intervention, which typically has other benefits (i.e., cheaper or safer), has similar clinical effectiveness to currently available treatments. In situations where interim evidence in a non-inferiority trial suggests that the novel treatment is truly inferior, ethical concerns with continuing randomisation to the "inferior" intervention are raised. Thus, if interim data indicate that concluding non-inferiority at the end of the trial is unlikely, stopping for futility should be considered. To date, limited examples are available to guide the development of stopping rules for non-inferiority trials.

Methods

We used a Bayesian predictive power approach to develop a stopping rule for futility for a trial collec

SUBMITTER: Heath A 

PROVIDER: S-EPMC7153169 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature