1 May 2026 - The US FDA is testing “real time clinical trials,” which it says will provide faster access to key decision making data so that drugs can be approved and reach patients sooner.

Unlike standard trials—where data are compiled and sent to the FDA only after each phase ends—real time trials will use AI to send agreed safety and endpoint signals to FDA reviewers as the study is running, in theory cutting the months of administrative “dead time” between phases. Two “proof of concept” real time clinical trials are now under way, and the agency is planning a larger pilot programme this summer, it announced on 28 April 2026.

Read BMJ article