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stat.ME2024
Biomarker-Guided Adaptive Enrichment Design with Threshold Detection for Clinical Trials with Time-to-Event Outcome
Kaiyuan Hua, Hwanhee Hong, Xiaofei Wang
Biomarker-guided designs are increasingly used to evaluate personalized treatments based on patients' biomarker status in Phase II and III clinical trials. With adaptive enrichment…
stat.ME2024
Inference of treatment effect and its regional modifiers using restricted mean survival time in multi-regional clinical trials
Kaiyuan Hua, Hwanhee Hong, Xiaofei Wang
Multi-regional clinical trials (MRCTs) play an increasingly crucial role in global pharmaceutical development by expediting data gathering and regulatory approval across diverse pa…