3 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
BARD: A seamless two-stage dose optimization design integrating backfill and adaptive randomization
Yixuan Zhao, Rachael Liu, Jianchang Lin +1
One common approach for dose optimization is a two-stage design, which initially conducts dose escalation to identify the maximum tolerated dose (MTD), followed by a randomization…
stat.ME2022
Seamless Phase 2-3 Design: A Useful Strategy to Reduce the Sample Size for Dose Optimization
Liyun Jiang, Ying Yuan
The traditional more-is-better dose selection paradigm, developed based on cytotoxic chemotherapeutics, is often problematic When applied to the development of novel molecularly ta…