S2: E2 AI in Clinical Research: Decoding Regulatory Expectations

On this episode, Dr. Tala Fakhouri (Associate Director for Data Science and Artificial Intelligence Policy, FDA) and Stephen Pyke (Chief Clinical Data & Digital Officer, Parexel) join the podcast to discuss how the FDA and regulators around the world are thinking about the use of AI in clinical research.They dive deeper into the FDA’s evidentiary standards for AI, what organizations should consider about methodological transparency in submissions, and AI’s potential as a tool that can help bring medicines to market more efficiently.For more information on ACRO's AI/ML Principles Statement, visit ACRO's website: https://www.acrohealth.org/initiatives-hub/ai-ml-in-drug-development/