3 Views From Inside FDA's RTCT Pilot

By Dan Schell, Chief Editor, Clinical Leader

For years, people in the clinical trial industry have complained that the FDA moved too slowly technologically. We’ve talked endlessly about modernization, digital transformation, AI, interoperability, and reducing the operational drag that slows drug development. So, when the FDA announced its Real-Time Clinical Trials (RTCT) pilot initiative on April 28, 2026, it felt like the kind of ambitious step many in the industry had been asking for, and cheers of “hurrah” could be heard reverberating throughout the country!

Oh wait … that’s not what happened.

Actually, almost as soon as the ink was dry (in the Internet/cloud computing Age, should we still even be using that phrase?), the initiative’s two most visible architects/champions, Commissioner Marty Makary and Jeremy Walsh, left the agency. Some people may say, “Big deal! This whole RTCT push is bigger than just those two and has a lot of other people backing it.” Indeed, that is true, but thus far, a new “champion” has not emerged. Like everything with these burgeoning initiatives … time will tell.

The concept has generated equal parts enthusiasm and skepticism across the industry. Supporters view it as a long-overdue modernization effort that could reduce operational burden and accelerate evidence generation. Critics worry the model could create pressure to react to immature signals, blur boundaries between sponsors and regulators, and introduce new governance challenges around AI-enabled systems and EHR integration. Sarah Moeller, a consultant and expert in regulatory inspection readiness and facilitation ( whom I interviewed last year for the article Spiders, Mold, & SOPs: Tales From A Site Inspection Veteran), is one of those skeptics. She recently commented on LinkedIn that this RTCT initiative, “… does not ensure the data has integrity or that the patients were consented appropriately by delegated, trained, and authorized individuals in a language appropriate to the patient. [Nor does it ensure] that the data has been monitored, queried, trended by data review plans and PV and the DMC [data monitoring committee].”

The FDA recently extended the public comment period on the RTCT initiative through June 29, 2026. And I think it’s worth reiterating — this is still just a pilot program.

Clinical Leader’s sister publication, Clinical Tech Leader, led by my long-time friend John Oncea, has already explored many of the technical implications of the initiative in a three-part series examining the infrastructure demands RTCTs could place on sponsors, sites, and technology vendors. I wanted to expand on some of the points John made in his series, so I reached out to three organizations directly involved in the pilot effort — Amgen, the University of Pennsylvania, and Paradigm Health — to get a better sense of how the initiative is actually being viewed by the people building and operating it.

A Push Toward Embedded Clinical Research

When I asked Paul Burton, MD, Ph.D., chief medical officer at Amgen, why the company believed the initiative was worth participating in, he framed it as an opportunity to evaluate whether a more routine-care-based model can work “credibly” while still preserving traditional development standards. “For Amgen, the primary objective is learning whether a more embedded, routine-care-based trial model can work credibly in a defined pilot setting. We want to understand whether this approach can reduce burden on patients and sites while maintaining the rigor, ethics, and regulatory discipline clinical development requires.” Burton also emphasized that “pragmatic does not mean less rigorous,” adding that “patient safety and data integrity remain central.” That same balance between efficiency and rigor surfaced repeatedly in the responses I received from all three of the SMEs.

I did like how Emma Meagher, MD, senior vice dean for clinical and translational research at the University of Pennsylvania Perelman School of Medicine, described RTCTs operationally as a significant departure from how clinical trial data typically flows today. “As soon as data is entered into the source documentation it can be transmitted,” she said, contrasting the model with the conventional process in which “the data [is] abstracted from the source, transferred to a data capture system, submitted to the sponsor, who aggregates it, then it is sent by the sponsor to the FDA.”

Still, Meagher was careful not to overpromise operational efficiencies during what remains a pilot phase. “It’s still too early to say, because setting up the system takes time, and training staff on the system will include a learning curve for both the sponsor and the site.”

That caution appeared consistently throughout everyone’s responses, which to me was important to note. It meant that even participants directly involved in the initiative acknowledged that many of the operational questions surrounding RTCTs can only be answered once the model is tested more broadly in active studies. Again, it’s just a pilot.

AI, Infrastructure, And Continuous Operations

Considering Paradigm Health’s platform is the technical backbone enabling these RTCT proof-of-concept studies, I asked company CEO, Kent Thoelke what had to change technologically to make real-time regulatory review feasible now versus, maybe five years ago. “The biggest technological change is that we now have the software infrastructure to embed study data collection into the point-of-care clinical workflow care, rather than waiting for post-hoc, batch-based, document-heavy cycles,” he said. Thoelke specifically 

pointed to maturation of LLMs as a major enabling factor behind the initiative, especially helping with document processing and as agents to do some of the more time-consuming paperwork.

He also suggested that if RTCT models eventually scale more broadly, traditional clinical operations workflows could look very different than they do today. “With technology that is closer to source, we can question the need for traditional SDV and push toward a future where AI agents are performing more of this work. With gas prices and travel costs increasing, we should all question whether we need to pay to fly monitors around the world or lean into technology advances to help increase efficiency.”

Thoelke added that he believes clinical operations will become more continuous and less back-end batch-oriented with sponsor review, site workflows, and data quality checks moving “closer to the visit or event rather than after long reconciliation windows.”

Concerns About Governance And Oversight

One of the more closely watched aspects of the RTCT initiative is how the FDA and sponsors will handle governance, oversight, and data interpretation in a near-real-time environment.

When asked about concerns that continuous regulatory visibility could create pressure to react to immature efficacy or safety signals, Burton pointed back to study governance and predefined data structures. “The key safeguard is disciplined study design and governance. More efficient data availability does not change evidentiary standards or the need for maturity and careful assessment.” He also noted that regulatory decisions would still depend on the totality of evidence and the FDA’s independent review.

I asked Meagher about the concerns many people have with regulators being “inside the trial” while studies are already ongoing. She acknowledged she’s heard these concerns, but she feels they are manageable based on the explanations received thus far from regulators, as well as the fact that sponsors have been willing to participate in the pilot. I see where she’s coming from, especially the part about the regulators. As we all know by now, the pilot is built around preidentified signal sharing; this isn’t just a constant flow of every data point. And perhaps most importantly, it does not replace existing regulatory review frameworks. But despite all of that, I agree with Meagher’s final disclaimer on these comments — “Again, time will tell.”

Similarly, Thoelke addressed questions surrounding privacy and unrestricted access to patient records. “FDA has been explicit that it is not seeking patient-level data or a raw EHR feed,” he said. “The FDA-facing output is predefined signal metadata tied to the agreed schema.” He added that the sponsor remains accountable “while existing safety and regulatory obligations remain in place.”

So, the comments from these three execs seem to reflect the broader industry’s discussion surrounding RTCTs — a little bit of optimism coupled with a good dose of caution. We’re still in the early stages of this initiative, after all. And if these three are focused less on debating the concept philosophically and more on determining whether the model can work operationally, scientifically, and regulatorily in practice, then I get it.