The Role of Artificial Intelligence in Clinical Trial Design and Research

https://www.fda.gov/media/178657/download?attachment=&utm_medium=email&utm_source=govdelivery Welcome to “Q&A with FDA,” from the FDA’s Division of Drug Information, where we aim to answer some of the most frequently asked questions that we’ve received from the public. Today we are joined by Dr. Khair ElZarrad, Director of the Office of Medical Policy within FDA’s Center for Drug Evaluation and Research, to discuss recent advances and use of technology in clinical trial design. Dr. ElZarrad leads the development, coordination, and implementation of medical policy programs and strategic initiatives and works to enhance policies and improve drug development and regulatory review processes. He was also recently awarded the 2023 Arthur Flemming Award, which honors outstanding employees. Generally, AI and machine learning can be described as machine-based systems that can, for a given set obviously, for human-defined objectives, make predictions, recommendations, or decisions. Those AI systems use machine- and human-based inputs to perceive real and virtual environments. They can abstract such perceptions into models in an automated manner. They use model inference typically to formulate options for information or action. Over the last few years, FDA has seen a rapid growth in the number of submissions that reference AI. Approximately 300 submissions we’ve received from 2016 to today reference AI use. These submissions transverse the landscape of drug development, all the way from discovery to clinical research, for example clinical trials in the beginning, but also to post-market safety surveillance and to even manufacturing, specifically advanced manufacturing. We are also working to better understand how the use of AI in any one specific setting relates to participants safety and the reliability of study results. The use of AI, including to facilitate data collection, this combined with robust information management, advanced computing abilities that we’ve been seeing increasingly in the recent year, are really transforming the way drugs are developed and used.