C3TI Areas of Interest
CDER Center for Clinical Trial Innovation (C3TI)
Programs exemplifying clinical trial innovation
For years, CDER has championed clinical trial innovation. Our activities span 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
- Enhancing the diversity of clinical trial populations
- International harmonization
- Public-private partnerships and external collaborations