Real-Time Clinical Trials: FDA's Big Bet or Big Mess?

The FDA just announced a bold push for real‑time clinical trials (RTCT) — including proof‑of‑concept studies, a new pilot program, and an RFI on AI-enabled tech to speed up decision‑making.

But from the site and operations side, does any of this actually solve the real problems?

In this Note to File episode, Denali and Brad dig into:

What the FDA actually said in the recent RTCT press conference
-The claim of "45% dead time" in trials – and what's really happening between last patient visit and submission
-Why data streaming to FDA in real time raises huge questions about
-Unclean / unadjudicated data
-Unblinding risks
-Sponsor exposure and control
-How vendors like Paradigm and eSource / EHR data streams are being positioned as the tech backbone
-Whether AI + interoperability can actually reduce timelines vs. just create new buzzwords
-The disconnect between patient recruitment as the true bottleneck and this focus on data plumbing
-Local vs. central IRBs, FDA commentary on IRB "modernization," and what that means for communities and oversight
-Why so many people are clapping on LinkedIn while the details remain incredibly vague

This is a skeptical but fair breakdown from the site-level trenches:
What could RTCT get right? Where is it wildly underbaked? And what should sites, sponsors, and vendors be watching closely as the RFI window closes and the pilot program takes shape?