Bayesian adaptive design for pediatric clinical trials incorporating a community of prior beliefs.

ABSTRACT:

Background

Pediatric population presents several barriers for clinical trial design and analysis, including ethical constraints on the sample size and slow accrual rate. Bayesian adaptive design methods could be considered to address these challenges in pediatric clinical trials.

Methods

We developed an innovative Bayesian adaptive design method and demonstrated the approach as a re-design of a published phase III pediatric trial. The innovative design used early success criteria based on skeptical prior and early futility criteria based on enthusiastic prior extrapolated from a historical adult trial, and the early and late stopping boundaries were calibrated to ensure a one-sided type I error of 2.5%. We also constructed several alternative designs which incorporated only

SUBMITTER: Wang Y 

PROVIDER: S-EPMC9027907 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature