2 papers
stat.AP2025
Regional consistency evaluation and sample size calculation under two MRCTs
Kunhai Qing, Xinru Ren, Shuping Jiang +3
Multi-regional clinical trial (MRCT) has been common practice for drug development and global registration. The FDA guidance `Demonstrating Substantial Evidence of Effectiveness fo…
stat.ME2025
A Hybrid Prior Bayesian Method for Combining Domestic Real-World Data and Overseas Data in Global Drug Development
Keer Chen, Zengyue Zheng, Pengfei Zhu +6
Background Hybrid clinical trial design integrates randomized controlled trials (RCTs) with real-world data (RWD) to enhance efficiency through dynamic incorporation of external da…