Consistency assessment and regional sample size calculation for MRCTs under random effects model
随机效应模型下多区域临床试验的一致性评估与样本量计算
Multi-regional clinical trials (MRCTs) have become common practice for drug development and global registration. Once overall significance is established, demonstrating regional consistency is critical for local health authorities. Methods for evaluating such consistency and calculating regional sample sizes have been proposed based on the fixed effects model using various criteria. To better account for the heterogeneity of treatment effects across regions, the random…