In April 2024, the U.S. Food and Drug Administration Center for Drug Evaluation and Research (CDER) introduced the Center for Clinical Trial Innovation (C3TI) to enhance communication and collaboration in clinical trials. C3TI aims to improve drug development efficiency through innovative approaches to trial design and conduct. It will act as a central hub for sharing lessons learned from CDER’s existing clinical trial innovation programs, offering support for non-product-specific questions, organizing discussion forums and workshops, and maintaining a knowledge repository on clinical trial innovation efforts.
The C3TI demonstration program is open to sponsors of innovative clinical trials in three initial project areas:
1. Streamlined trials embedded in clinical practice, focusing on pragmatic design elements to address statistical analysis, real-world data incorporation, endpoint selection, and inspectional approaches.
2. Bayesian supplemental analyses for phase 3 trials to enhance understanding of Bayesian methods.
3. Selective safety data collection for late-stage trials on drug products with well-characterized safety profiles to streamline data collection and allocate resources effectively.
Interested sponsors can submit proposals to the relevant application and notify the FDA of their submission via email. The program will accept up to nine proposals within a 12-month period, aiming to advance innovative approaches in clinical trials.
Since its launch, C3TI has introduced the C3TI Compass, a searchable database listing CDER’s clinical trial innovation activities and experiences. Additionally, a recent public workshop discussed the use of complex innovative designs in clinical trials, emphasizing Bayesian methods, external data sources, and simulations.
Overall, C3TI is a significant step towards improving the efficiency and effectiveness of clinical trials, ultimately benefiting patient safety and advancing drug development processes. The initiative’s focus on collaboration and innovation highlights the FDA’s commitment to fostering advancements in the pharmaceutical industry. Through ongoing updates and programs, C3TI is set to play a pivotal role in shaping the future of clinical trials and drug development.
