C3TI Knowledge Repository

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:

1. Complex Innovative Trial Designs
2. Digital Health Technologies ​
3. Drug Development Tool Qualification​
4. Model-Informed Drug Development ​
5. Patient-Focused Drug Development ​
6. Rare Disease Endpoint Advancement ​
7. 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 

Efforts are underway to develop and share a centralized knowledge repository. This repository will curate knowledge about completed CDER clinical trial innovation activities and maintain a comprehensive portfolio of ongoing efforts and knowledge resources. Further details coming soon!

Connect with us

CDERclinicaltrialinnovation@fda.hhs.gov