FDA announced two initiated real-time endpoint/data-signal reporting proofs of concept and separately requested information on a proposed AI-enabled early-phase-trial pilot.

Provenance

First verified

2026-04-28

Source updated

2026-05-27

Revision state

Version 1.1 separates the two initiated real-time reporting proofs from the distinct proposed AI-enabled pilot, records the closed RFI and unestablished later outcome, and records the September 3, 2026 re-verification.

Last verified

2026-09-03

Status

Two proofs initiated · separate AI-enabled pilot RFI closed · later outcome not established

Freshness

Changed

Version

1.1

Fingerprint

66185a1bc2561cd2

Change sensitivity

Medium

Evidence limits

The initiated proofs do not establish comparative benefit. The separate AI-enabled pilot RFI closed June 29, 2026; the cited source does not establish a later selection or broader-pilot launch outcome.

Primary source

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

Related signals

• SIG-2026-016 — FDA launches real-time clinical-trial proofs of concept