AI Adoption Outpaces Evidence Generation in Clinical Trials

What happened

By 2024, 71% of U.S. hospitals used predictive AI in EHRs, outpacing regulations. A study of 9,600 patients in Kenya showed AI improved decision-making quality without changing short-term outcomes. The FDA issued guidance on change control plans in December 2024 (updated August 2025) but lacks operational details for active trials.

Why it matters

Sponsors must account for AI tools as effect modifiers in RWE studies. Sites need to document active AI tools and change control processes to mitigate risks of undetected confounders and protocol deviations.