Evidence Explorer · EV-015

Real-time clinical trials

FDA announced real-time clinical-trial proofs of concept using AI and data science to improve data flow, safety monitoring, and decision speed.

E596/100 confidenceFederal regulatory innovation initiative

What this evidence supports

FDA is testing real-time clinical-trial approaches enabled by AI and data science.

What it does not establish

Proofs of concept do not establish that real-time approaches will be appropriate or superior for every trial.

Record details

Source authority
FDA
Evidence level
E5
Directness
5/5
Recency
4/5
Decision relevance
5/5
Date
2026-04-28

Primary source

https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials

Related intelligence

FDA launches real-time clinical-trial proofs of concept