Modification and extension of the Bayesian clinical trial design using external data for single-arm and hybrid-controlled trials
利用外部数据的贝叶斯单臂与混合对照临床试验设计:修正与扩展
Limited patient availability complicates sample size determination in pediatric clinical trials. Although Bayesian methods incorporating external data offer a solution, rigorously controlling the type I error rate remains difficult. Psioda and Ibrahim (2019) proposed a simulation-based framework as a practical solution. However, although their framework was designed to relax the type I error control, this relaxation fails when the external data exhibit a large treatment…