Key Study Design & Outcomes Projects from the FDA’s Oncology Center of Excellence

The FDA’s Oncology Center of Excellence (OCE) has created over 300 projects and programs that are dedicated to advancing the development and regulation of medical products for cancer patients. Among these, there is a subset that is most essential to the study design and outcomes of your oncology clinical development program. This resource covers Project Optimus, Project Confirm, Project FrontRunner, and Project Pragmatica, their purpose, and how they can be applied to your program.