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

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The FDA’s Oncology Center of Excellence has created a number of projects and programs aimed at enhancing study designs and outcomes for oncology drug development. These initiatives are part of the OCE’s commitment to foster the development and regulation of cancer treatments, ensuring they meet the highest standards of care. For a comprehensive overview of each project and how you can apply them to accelerate your study, check out our guide.

Key Projects Included:

  • Project Optimus: Focuses on dose optimization to refine early phase drug development
  • Project Confirm: Provides a revised framework for accelerated approvals
  • Project FrontRunner: Offers opportunities for earlier access to treatments
  • Project Pragmatica: Aims to modernize clinical evidence generation through pragmatic clinical trial designs


Matthew Confeld, PharmD, PhD
Assistant Director, Clinical Research Methodology

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