3 papers
stat.AP2026
Consistency Assessment of Regional Treatment Effect for Multi-Regional Clinical Trials in the Presence of Covariate Shift
Kunhai Qing, Xinru Ren, Jin Xu +1
Multi-Regional Clinical Trials (MRCTs) play a central role in the development of new therapies by enabling the simultaneous evaluation of drug efficacy and safety across diverse gl…
stat.ME2025
Consistency assessment and regional sample size calculation for MRCTs under random effects model
Xinru Ren, Jin Xu
Multi-regional clinical trials (MRCTs) have become common practice for drug development and global registration. Once overall significance is established, demonstrating regional co…
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…