By John Potter 
 
September 2, 2026 | The FDA's Real-Time Clinical Trials (RTCT) initiative is testing whether earlier access to selected clinical trial data can improve regulatory oversight by allowing reviewers to observe selected safety and efficacy signals while studies remain underway. Under the proof-of-concept pilot announced in April, participating sponsors share agreed-upon data elements rather than giving FDA reviewers unrestricted access to complete trial databases. 

Former FDA Commissioner Janet Woodcock, MD, questioned whether the approach would have broad practical value outside a relatively small number of high-risk studies. “I’m afraid I have a different view of this,” Woodcock told Clinical Research News. “I spent 30 years at FDA including as a primary reviewer, so I know of what I speak.” 

Woodcock, who also led the FDA's Center for Drug Evaluation and Research, said the agency already relies on multiple layers of safety oversight during ongoing trials, including investigators, sponsors and independent data monitoring committees. At the same time, she said, agency reviewers are already stretched reviewing investigational applications, marketing submissions, and safety reports. 

"In my opinion, generally, RTCT will be an extremely modest tool only for use in special circumstances," Woodcock said. "Why? There are many thousands of trials going on and only some hundreds of FDA reviewers. There is a reporting system set up for reacting to adverse events in clinical trials, and the PIs, who are almost always MDs, are in charge of overseeing safety at the point of care. It doesn't add anything to have another layer, and the FDA review staff does not have the time." 

Woodcock also questioned how useful near-live data would be during blinded efficacy trials, where reviewers lack the context needed to interpret individual adverse events. Instead, she pointed to independent data monitoring committees, which review unblinded data and can recommend stopping a trial for safety or futility when necessary. 

She said other approaches, including seamless Bayesian trial designs that reduce delays between study phases, could have a greater impact on shortening development timelines than continuous regulatory visibility. 

Preparing for Continuous Review 

While Woodcock questioned how broadly RTCT would ultimately be adopted, Novotech Vice President of Regulatory Affairs Renita Hite said that if the model expands, sponsors will need to rethink how clinical trials are managed. Novotech is a global contract research organization (CRO) that supports sponsors in clinical trial development. 

“The biggest change is moving from reviewing data at scheduled points to being ready for it on a more continuous basis,” Hite said. “Many sponsors still work around planned data reviews, database locks, and reporting milestones. A near-live model raises the expectation that predefined signals are accurate, complete, and available much earlier." 

In a continuous review environment, Hite said the shift goes beyond simply transmitting data more quickly. "The most significant shift is not simply faster data availability but moving from periodic regulatory readiness toward an operating model that can support earlier and more continuous regulatory visibility." 

Hite said sponsors would need to establish governance processes before patient enrollment, defining which signals will be shared, who reviews them, and what level of change requires escalation. 

“Technology may enable the information to move, but governance determines whether that information can be used responsibly,” Hite said. “Before a study begins, sponsors would need to agree on which signals will be shared, how those signals are defined, who reviews them, and what level of change requires escalation.” 

Hite believes success under an RTCT model will depend less on faster data transmission than on governance and operational workflows that support continuous regulatory review. 

Laying the Foundation for RTCT 

Fortrea Vice President and Head of Regulatory Strategy Alicia Baker said RTCT changes how sponsors should think about regulatory engagement. Fortrea is also a global CRO that supports sponsors through clinical development and regulatory planning. 

“Sponsors need to start thinking of regulatory review as an ongoing process rather than a milestone event,” Baker said. “That means having cleaner data flows, faster issue escalation, stronger cross-functional governance, and clear plans for how emerging signals will be assessed and communicated, both internally and to the regulators.” 

Baker said sponsors should pressure-test internal workflows using realistic clinical trial scenarios before implementation to identify governance gaps and protect data integrity. 

“If the organization cannot quickly answer who reviews the signal, what decisions can be made, how those decisions are documented, and how the full audit trail is maintained, the governance model is probably not ready for RTCT,” Baker said. “The goal is to identify gaps before FDA is looking at the same data in near real time.” 

Greenlight Compliance CEO Sarah Moeller echoed that emphasis on early preparation, saying sponsors also need to build inspection readiness into trial planning rather than waiting until the end of a study. 

"Sponsors must be inspection ready from the moment they begin planning for a trial, instead of waiting until the end of the trial," Moeller said. 

An Ecosystem Challenge 

Former FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD, said the changes required for RTCT extend beyond individual sponsors. 

“As we noted in our RTCT Program docket comment, this is fundamentally an ecosystem challenge, not just a sponsor challenge,” Abernethy said. “Success will require coordinated efforts across sponsors, health systems, clinical research teams, technology vendors, CROs, patients, and regulators.” 

Abernethy said scaling RTCT will require modern data infrastructure, interoperability and common standards that allow clinical information to move reliably across sponsors, health systems, and regulators. 

Whether RTCT ultimately becomes a specialized tool for selected studies or expands more broadly remains an open question. Woodcock questioned how widely the initiative will ultimately be adopted. Hite, Baker, and Abernethy instead focused on what sponsors and the broader clinical research ecosystem would need to make continuous regulatory engagement possible: stronger governance, operational readiness, and modern data infrastructure. 

“What’s different today isn’t the vision, it’s the technology,” Abernethy said.