FDA Highlights Potential for AI to Advance Clinical Trial Design and Implementation
Summary
In a podcast hosted by the Food and Drug Administration (FDA), Dr. ElZarrad, Director of the Office of Medical Policy within FDA’s Center for Drug Evaluation and Research, discussed the role of AI in clinical trials currently and the potential for AI to further modernize clinical trials to support drug development. Over the past eight years, FDA has received approximately 300 submissions that reference AI use, ranging from relatively simple applications to more complex uses across clinical research, post-market surveillance and advanced manufacturing. These submissions demonstrate that AI is currently being used in clinical research to streamline data collection, analyze vast amounts of data, improve medication adherence, characterize and predict pharmacokinetic profiles and facilitate real-time communication with patients.
FDA plans to encourage the use of AI, paired with other digital health technologies, to identify patients who may be well-suited for certain clinical trials and increase recruitment. Dr. ElZarrad also expressed concern about the variability in quality, size and representativeness of data sets, along with the need to avoid degradation over time (known as “data drift”). The agency continues to highlight the importance of transparency and lifecycle monitoring to address these risks.
