2 papers
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),…
stat.ME2024
ROMI: A Randomized Two-Stage Basket Trial Design to Optimize Doses for Multiple Indications
Shuqi Wang, Peter F. Thall, Kentaro Takeda +1
Optimizing doses for multiple indications is challenging. The pooled approach of finding a single optimal biological dose (OBD) for all indications ignores that dose-response or do…