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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),…
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…
BOP2-TE: Bayesian Optimal Phase 2 Design for Jointly Monitoring Efficacy and Toxicity with Application to Dose Optimization
Kai Chen, Heng Zhou, J. Jack Lee +1
We propose a Bayesian optimal phase 2 design for jointly monitoring efficacy and toxicity, referred to as BOP2-TE, to improve the operating characteristics of the BOP2 design propo…
Statistical and Practical Considerations in Planning and Conduct of Dose Optimization Trials
Ying Yuan, Heng Zhou, Suyu Liu
The US Food and Drug Administration launched Project Optimus with the aim of shifting the paradigm of dose-finding and selection towards identifying the optimal biological dose tha…
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…