A Bayesian non-inferiority approach using experts' margin elicitation - application to the monitoring of safety events.

ABSTRACT:

Background

When conducing Phase-III trial, regulatory agencies and investigators might want to get reliable information about rare but serious safety outcomes during the trial. Bayesian non-inferiority approaches have been developed, but commonly utilize historical placebo-controlled data to define the margin, depend on a single final analysis, and no recommendation is provided to define the prespecified decision threshold. In this study, we propose a non-inferiority Bayesian approach for sequential monitoring of rare dichotomous safety events incorporating experts' opinions on margins.

Methods

A Bayesian decision criterion was constructed to monitor four safety events during a non-inferiority trial conducted on pregnant women at risk for premature delivery. Based on experts

SUBMITTER: Aupiais C 

PROVIDER: S-EPMC6751616 | biostudies-literature | 2019 Sep

REPOSITORIES: biostudies-literature