Sep 2026
A Seamless Phase I/II Design With Randomization for Biomarker-Guided Oncology Trials.
The FDA's Project Optimus CALLS for randomized exploration of multiple doses to better refine selection of the optimal biologic dose (OBD). Project FrontRunner encourages the use of randomized controlled trials earlier in the drug development process. We propose a seamless three-stage trial design that addresses both g...
Emily C. Zabor, Sneha Govande, Wen-Wee Ma et al.
· Pharmaceutical statistics · 0 citations