2 papers
stat.ME2026
A Practical Framework for Sensitivity Analysis in Externally Controlled Trials: An Illustration with a Bayesian Hybrid Evidence Synthesis Case Study
Xuemin Gu, Kitty Guo, Jane Zhang
Externally controlled trials (ECTs), including single-arm studies augmented with historical data and hybrid randomized designs with partial external augmentation, are increasingly…
stat.AP2026
A Utility Score Framework for Dose Optimization Studies with Binary Efficacy-Safety Endpoints: Sample Size Determination and Bias Characterization
Xuemin Gu, Cong Xu, Lei Xu +1
The FDA's Project Optimus initiative emphasizes patient-centered dose selection in oncology that balances efficacy and safety. We develop a framework for randomized dose optimizati…