The US Food and Drug Administration (FDA) is launching a pilot to implement real-time clinical trials (RTCT).
While announcing the pilot, the FDA revealed that two proof-of-concept clinical trials have been successfully initiated, which will report endpoints and data signals to the agency in real time, from AstraZeneca and Amgen.
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AstraZeneca is conducting a Phase II multi-site trial, TRAVERSE, in patients with treatment-naïve mantle cell lymphoma, with participation from The University of Texas MD Anderson Cancer Center and the University of Pennsylvania.
Amgen is conducting a Phase Ib trial, STREAM-SCLC, in patients with limited-stage small cell lung carcinoma. The final site selection is in process.
For each trial, the FDA met with the sponsor on the establishment of criteria for reporting signals in real time. The agency has since received and validated signals for AstraZeneca’s trial through Paradigm Health’s Study Conduct Platform, which automates data collection and analysis while improving how key safety and efficacy signals are reported to both trial sponsors and regulators, supporting more efficient oversight. The software is part of Paradigm Health’s broader Scalable Platform for Integrated Research & Evidence (SPIRE) end-to-end clinical trial platform.
Further expansion
Beyond AstraZeneca and Amgen’s studies, the FDA has released a Request for Information (RFI) regarding a proposed pilot programme for RTCT that will launch this summer.
All clinical trials running through the RTCT programme will utilise Paradigm Health’s platform as part of a collaboration between the company and the FDA.
Kent Thoelke, founder and CEO of Paradigm Health, said: “This collaboration represents an important step toward expediting how clinical trial data is submitted to and reviewed by the FDA. With Paradigm Health’s platform, clinical trial data can be analysed for key signals in near real time and shared with trial sponsors and the FDA in days, rather than months. This means that regulators, sponsors, and providers can have a continuous view of safety and efficacy. By modernising the flow of information from sites to sponsors to regulators, we have an opportunity to accelerate the delivery of innovative therapies to patients across the country.”
Early-phase clinical trials are often a bottleneck in drug development, with high uncertainty, limited patient populations, and inefficient decision-making processes creating a difficult territory for early-stage medicines. Data is typically reported from sites to sponsors, who analyse and subsequently submit data to the FDA.
FDA Commissioner, Dr Marty Makary, said: “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.”
Makary said the RTCT framework is a modern approach that will help FDA scientists view safety signals and endpoints in real time as the 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,” he added.
RTCTs are an important step towards the agency’s goal of facilitating continuous trials. Current standards slow the pace of product development, the FDA said that RTCTs will eliminate or reduce the timelines to a minimum, enabling “continuous” trials.
Industry overall in support
Contract research organisation (CRO) Parexel has spoken out in favour of the RTCT programme, stating it aligns with a focus on driving speed, predictability, and data advantage in clinical trials.
“We have invested in AI, built deep regulatory relationships, and can support continuous data flows, meaning we are absolutely ready and excited to partner with FDA and sponsors to scale this model,” said Peyton Howell, CEO of Parexel. “We are already working with our large pharma partners on in-progress studies and designing pilots for this programme. Access for biotech sponsors will be critical.”
Speaking on LinkedIn, Massoud Toussi, vice president of Real World Evidence (RWE) at United BioSource, said that it could also be expanded to include RWE studies and potentially provide synthetic dashboards.
Meanwhile, Florin Muraru, group head of global regulatory affairs at the Helsinn Group, also speaking on LinkedIn, said that while this may be an easy way for large pharma, smaller biotech may struggle.
The agency will accept comments on the RFI until 29 May 2026.
