2 papers
stat.AP2025
Adjustment for Inconsistency in Adaptive Phase 2/3 Designs with Dose Optimization
Cong Chen, Mo Huang
Adaptive Phase 2/3 designs hold great promise in contemporary oncology drug development, especially when limited data from Phase 1 dose-finding is insufficient for identifying an o…
stat.AP2024
Adaptive Phase 2/3 Design with Dose Optimization
Cong Chen, Mo Huang, Xuekui Zhang
FDA's Project Optimus initiative for oncology drug development emphasizes selecting a dose that optimizes both efficacy and safety. When an inferentially adaptive Phase 2/3 design…