The U.S. Food and Drug Administration announced the launch of two proof-of-concept real-time clinical trials and published a Request for Information related to a pilot program the agency plans to begin this summer.
Two industry sponsors are running the initial trials. AstraZeneca is leading a Phase 2, multi-site study named TRAVERSE in patients with treatment-na ve mantle cell lymphoma. The trial includes participation from The University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Separately, Amgen is conducting a Phase 1b trial called STREAM-SCLC in patients with limited-stage small cell lung carcinoma; final site selection for that study is in process.
As part of preparations for the pilot, the FDA met individually with each sponsor to set criteria for reporting signals in real time. In AstraZeneca s case, the agency has received and validated signals routed through Paradigm Health, demonstrating the technical framework for real-time signal sharing can function in practice for that study.
FDA Commissioner Marty Makary described the shift in process, saying, "For 60 years, we ve been conducting clinical trials in the same way, where key data signals can take years to reach the FDA. We are boldly advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses."
The real-time clinical trial model departs from the traditional flow of information in which data travel from trial sites to sponsors and then to regulators following sponsor analysis. Under the new approach, key trial data can be transmitted directly to the FDA as the trial is under way.
To gather stakeholder input on how to structure and assess the pilot, the agency released a Request for Information asking for comments on pilot design, implementation, evaluation metrics, and success criteria. The FDA will accept responses through May 29, 2026. The agency indicated it plans to publish final selection criteria in July and to complete pilot selections in August.
Context and implications
These initial proof-of-concept trials and the parallel Request for Information are intended to test both the operational and technical aspects of delivering trial signals to regulators in near real time. With one trial already demonstrating validated signal transmission through an external intermediary, the effort seeks to determine whether broader adoption is feasible under defined pilot parameters.
While the program is positioned to begin this summer, several procedural steps remain, including public comment, finalization of selection criteria, and completion of pilot selections.