5 papers
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…
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…
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…
A general, flexible and harmonious framework to construct interpretable functions in regression analysis
Tianyu Zhan, Jian Kang
An interpretable model or method has several appealing features, such as reliability to adversarial examples, transparency of decision-making, and communication facilitator. Howeve…
A Class of Computational Methods to Reduce Selection Bias when Designing Phase 3 Clinical Trials
Tianyu Zhan
When designing confirmatory Phase 3 studies, one usually evaluates one or more efficacious and safe treatment option(s) based on data from previous studies. However, several retros…