The FDA has announced a couple of major steps towards the implementation of real-time clinical trials (RTCTs), which would allow reviewers to obtain information from clinical trials in real time.
In a press announcement on April 28, 2026, the FDA revealed the launch of proof-of-concept RTCTs along with a forthcoming pilot program designed to expand this approach across the industry.
To scale the initiative from proof-of-concept, the FDA has issued a Request for Information (RFI) seeking stakeholder feedback on a planned RTCT pilot program set to launch this summer. The agency said it will accept comments on the RFI until May 29, 2026, and will disseminate final selection criteria in July and complete pilot selections in August.
The pilot will explore key elements such as study design and implementation frameworks; metrics for evaluating success; and the role of AI in enhancing trial efficiency and decision-making. The agency aims to finalize pilot criteria by mid-2026 and select participating programs shortly thereafter.
“For 60 years, we’ve been conducting clinical trials in the same way, where key data signals can take years to reach the FDA. The lag time can delay regulatory decisions unnecessarily and slow down the drug development timeline,” said FDA Commissioner Marty Makary, MD, MPH.
“We are boldly advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses. This will help us accelerate promising therapies, and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development.”
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The FDA has already initiated two RTCT proof-of-concept studies in collaboration with two major pharma giants, AstraZeneca and Amgen. AstraZeneca is conducting the Phase II TrAVeRse trial in treatment-naïve mantle cell lymphoma, involving institutions such as MD Anderson Cancer Center and the University of Pennsylvania, while Amgen is running the Phase Ib STREAM-SCLC study in limited-stage small cell lung cancer.
In these trials, predefined safety and efficacy signals are shared with the FDA in real time.
The infrastructure supporting this system includes modern cloud-based platforms and AI-driven analytics capable of securely transmitting and interpreting clinical data as it is generated.
All trials conducted through the RTCT program will use Paradigm Health’s platform as part of a collaboration between the company and the FDA.
The FDA envisions RTCTs as a stepping stone toward “continuous trials,” a model that eliminates the traditional pauses between clinical phases.
Currently, drug development is segmented into discrete phases (Phase I, II, III), often separated by gaps for data analysis and regulatory review, the FDA explained.
Data is packaged at the end of each phase of a clinical study, which can be tedious, redundant and a major cause of delays, Makary explained in an FDA press conference announcing the RTCT initiative.
These interruptions contribute significantly to the overall development timeline, slowing the pace of development, the agency said. By enabling continuous data flow and real-time oversight, RTCTs could reduce or even eliminate these gaps.
“For the last 50 years, the medical profession has sadly grown to accept a ten to 12-year timeframe for new drugs to come to market. As a result, patients are getting drugs in a delayed fashion when they could be getting them sooner,” Makary said. He said important questions need to be asked, including whether we can do better by using new technology and making communications with sponsors more efficient.
Malarky said 45% of the drug development time is “dead time” between the initiation of a Phase I trial and the FDA application at the end, during which investigators and staff are doing tedious paperwork and other tasks. And he said that “dead time” has been expanding, from 25% to 35%, and now 45%.
In one case, he said the FDA received an application that was 66 million pages.
Clinical trials have long followed a linear and fragmented process. Data is typically collected at study sites, sent to sponsors for analysis and then submitted to regulators, often resulting in substantial delays.
“Because real-time trials allow the FDA to view key insights in real time, this hiatus could be eliminated or reduced to a minimum, enabling “continuous trials,” the FDA stated in its press release.
In RTCTs, trial data, including safety signals and efficacy endpoints, can be transmitted directly to the FDA as the study progresses. This enables regulators to monitor trials continuously rather than retrospectively.
Industry players have mostly been receptive to the new pilot. Contract research organization (CRO) Parexel has stated that the new program aligns with a focus on driving speed, predictability and data advantage in clinical trials.
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From reporting by Fierce Biotech, experts like Stephanie Morain, PhD, a bioethicist at Johns Hopkins University, are receptive to efforts to reduce administrative burden.
At the same time, she highlighted concerns about striking the right balance between accelerating drug development and ensuring new therapies are thoroughly evaluated for safety and effectiveness.
“Patients want earlier access to new therapies, but they have interest in those therapies being safe and effective,” Morain said. Additionally, if a moderately effective therapy reaches the market through an accelerated review, it may discourage other companies from investing in the development of more innovative treatments in the same area.
Makary noted that the RTCT initiative is part of a broader push by the FDA to accelerate drug development. However, similar efforts introduced under his leadership have drawn criticism.
The agency’s generative AI tool, Elsa, has been flagged for producing inaccurate or information stemming from “AI hallucinations,” while the Commissioner’s National Priority Voucher (CNPV) program has raised concerns about transparency and potential conflicts of interest.
Under Makary’s leadership, the FDA has also undergone waves of layoffs affecting scientific reviewers, policy staff and administrative personnel across multiple centers, including cuts at the FDA, NIH and CDC. The reductions have sparked concern about the agency’s capacity to maintain rigorous oversight while simultaneously pursuing faster approvals.
Former senior officials have also warned of increasing political interference in regulatory decision-making, raising questions about whether speed-focused reforms could come at the expense of scientific independence and public trust.
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