2 papers
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…
stat.ME2025
ROSE: Randomized Optimal Selection Design for Dose Optimization
Shuqi Wang, Ying Yuan, Suyu Liu
The U.S. Food and Drug Administration (FDA) launched Project Optimus to shift the objective of dose selection from the maximum tolerated dose to the optimal biological dose (OBD),…