Artificial intelligence and machine learning (AI/ML) hold great potential to transform how medical products are discovered, tested, manufactured, and utilized. As with any innovation, AI/ML use in medical product development creates new and unique challenges that require both careful management and understanding. In January 2025, FDA introduced a risk-based regulatory framework to evaluate AI/ML in drug development in a way that supports innovation. 

CTTI is dedicated to advancing the responsible use of artificial intelligence in medical product development. CTTI's workstreams focus on establishing guiding principles, sharing real-world case studies, and exploring evaluation methods for AI/ML applications. We aim to ensure that AI/ML is used effectively and safely to enhance clinical trials, and that the community is able to learn and scale as efficiently as possible.   

CTTI created the Emerging Programs AI Workgroup and co-hosted a public workshop in 2024 to provide a space where those grounded in knowledge can discuss AI/ML applications in clinical trials and keep pulse on where things are headed through relevant publications and case examples. In 2025, the AI Workgroup convened additional workgroup meetings, and summaries from these discussions are now available on the CTTI website. CTTI also co-hosted a second public workshop, and a summary from that workshop will be posted soon.