Foley Attorneys Assess AI Use in Clinical Trials

Foley & Lardner LLP partners Monica Chmielewski and Kyle Faget shared insights on the growing adoption of artificial intelligence in clinical trials in the Clinical Trials Arena article, “Are regulators keeping pace with AI adoption in clinical trials?“

Chmielewski, highlighting the U.S. Food and Drug Administration’s January 2025 guidance on the subject, said it is a “great start” that clearly signals regulator awareness of the increasing application of AI in clinical trials. She noted that it is a quickly evolving space, and regulators typically run behind in keeping pace with technological developments.

Faget explained that though the FDA is working to address AI use, given the speed of its evolution, it is difficult for the agency to keep up. She identified data bias as a key issue creating challenges in the absence of regulation and emphasized the need for improved privacy and data security management with AI use as areas of concern for the industry.

Faget added that patient recruitment is a good use case for AI, including in data collection from patients, predictive modelling, and real-world evidence trials.