collaborators

1 paper

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…