3 papers
stat.AP2026
Synergy Area with FDR-controlled Evaluation (SAFE) to robustly assess safety profile in clinical trials
Tianyu Zhan, Yabing Mai, Yihua Gu +2
Safety assessment plays a fundamental role in developing a new drug via clinical trials for ethical considerations. Due to complexity, manual review is typically conducted on the t…
stat.ME2025
An Integrated and Coherent Framework for Point Estimation and Hypothesis Testing with Concurrent Controls in Platform Trials
Tianyu Zhan, Jane Zhang, Lei Shu +1
A platform trial with a master protocol provides an infrastructure to ethically and efficiently evaluate multiple treatment options in multiple diseases. Given that certain study d…
stat.ME2025
Semiparametric Weighted Spline Regression (SWSR) in Confirmatory Clinical Trials with Time-Varying Placebo Effects
Tianyu Zhan, Yihua Gu
In confirmatory Phase 3 clinical trials with recruitment over the years, the underlying placebo effect may follow an unknown temporal trend. Taking a clinical trial on Hidradenitis…