The US Food and Drug Administration (FDA) has announced a pilot programme to implement real-time clinical trials (RTCT), marking a shift in how clinical data is generated, shared, and reviewed. The initiative aims to provide regulators with continuous access to trial data, potentially reducing delays in decision-making and accelerating drug development timelines.
As part of the pilot, two proof-of-concept studies have been launched. AstraZeneca is conducting the Phase II TRAVERSE trial in treatment-naïve mantle cell lymphoma across multiple sites, including The University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is leading the Phase Ib STREAM-SCLC trial in limited-stage small cell lung carcinoma, with site selection ongoing.
For both studies, the FDA has worked with sponsors to define criteria for reporting safety and efficacy signals in real time. The agency has already received and validated signals from AstraZeneca’s trial באמצעות Paradigm Health’s Study Conduct Platform. The system automates data collection and analysis, enabling near real-time reporting through the company’s broader SPIRE clinical trial platform.
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.”
The FDA has also issued a Request for Information (RFI) ahead of a broader rollout planned for summer 2026, with all participating trials expected to use Paradigm Health’s platform.
FDA Commissioner Dr Marty Makary highlighted the limitations of traditional approaches, stating: “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.” He added, “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.”
Industry stakeholders have largely supported the initiative. Parexel CEO Peyton Howell said: “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.” However, some experts have noted potential challenges for smaller biotech companies in adopting the new framework.
Click here for the original news story.
