4 papers
A Bayesian predictive framework for adaptive interim-analysis timing with robust borrowing in confirmatory trials
Meihua Long, Tianyu Zheng, Jiali Song +4
Confirmatory phase III trials require rigorous evidence, yet for first-in-class (FIC) therapies they must often be designed when same-mechanism evidence is scarce. This uncertainty…
Synthetic Heterogeneous-Effects LASSO: A Fixed-effects Estimation Approach for High-dimensional Mixed-effects Models
Shangyuan Ye, Cong Zhang, Ying Chen +2
This paper studies variable selection and post-selection inference for high-dimensional clustered data using marginal-model-based procedures. We show that, when covariates are hete…
A Workflow for Evaluating Regional Treatment Effect Heterogeneity in Multi-Regional Clinical Trials
Cong Zhang, Meihua Long, Tianyu Zheng +8
Multi-regional clinical trials (MRCTs) enable efficient global drug development by assessing treatment effects across regions within a single protocol. While powered for overall ef…
WATCH: A Workflow to Assess Treatment Effect Heterogeneity in Drug Development for Clinical Trial Sponsors
Konstantinos Sechidis, Sophie Sun, Yao Chen +8
This paper proposes a Workflow for Assessing Treatment effeCt Heterogeneity (WATCH) in clinical drug development targeted at clinical trial sponsors. WATCH is designed to address t…