Inference of treatment effect and its regional modifiers using restricted mean survival time in multi-regional clinical trials
多区域临床试验中基于限制平均生存时间的处理效应及区域修饰因素推断
Multi-regional clinical trials (MRCTs) play an increasingly crucial role in global pharmaceutical development by expediting data gathering and regulatory approval across diverse patient populations. However, differences in recruitment practices and regional demographics often lead to variations in study participant characteristics, potentially biasing treatment effect estimates and undermining treatment effect consistency assessment across regions. To address this challenge,…