Handling Poor Accrual in Pediatric Trials: A Simulation Study Using a Bayesian Approach.

ABSTRACT: In the conduction of trials, a common situation is related to potential difficulties in recruiting the planned sample size as provided by the study design. A Bayesian analysis of such trials might provide a framework to combine prior evidence with current evidence, and it is an accepted approach by regulatory agencies. However, especially for small trials, the Bayesian inference may be severely conditioned by the prior choices. The Renal Scarring Urinary Infection (RESCUE) trial, a pediatric trial that was a candidate for early termination due to underrecruitment, served as a motivating example to investigate the effects of the prior choices on small trial inference. The trial outcomes were simulated by assuming 50 scenarios combining different sample sizes and true absolute risk reduction

SUBMITTER: Azzolina D 

PROVIDER: S-EPMC7924849 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature