C3TI Areas of Interest
CDER Center for Clinical Trial Innovation (C3TI)
For years, CDER has championed clinical trial innovation. C3TI amplifies CDER’s existing innovation programs and aims to spur future clinical trial innovation activities. Our work spans drug development programs, therapeutic areas, and disciplines through programs such as:
- Complex Innovative Trial Designs
- Digital Health Technologies
- Drug Development Tool Qualification
- Model-Informed Drug Development
- Patient-Focused Drug Development
- Rare Disease Endpoint Advancement
- Real-World Evidence
Additional focus areas:
- Artificial intelligence and machine learning
- Decentralized clinical trials
- International harmonization
- Public-private partnerships and external collaborations