In what is said to be a "bold modernization of clinical research," the U.S. FDA has taken two major steps toward implementing real-time clinical trials- an approach that could allow regulators to view safety signals and key endpoints as they happen.
Early-phase clinical trials are often slowed by fragmented data reporting, limited patient populations, and long delays between data collection and FDA review. Traditionally, trial sites send data to sponsors, who analyze and later submit findings to the agency- a process that can take months or even years. The FDA has now launched two proof-of-concept real-time clinical trials (RTCTs) with AstraZeneca and Amgen.
AstraZeneca's Phase 2 TRAVERSE study in treatment-naïve mantle cell lymphoma and Amgen's Phase 1b STREAM-SCLC trial in limited-stage small cell lung cancer are the first to transmit validated data signals directly to the FDA in real time. The agency confirmed it has already received and validated signals from AstraZeneca's trial through Paradigm Health, demonstrating the technical feasibility of the model.
Alongside these early trials, the FDA has issued a Request for Information (RFI) to shape a broader RTCT pilot program expected to launch this summer. The agency is seeking input on pilot design, evaluation metrics, and criteria for selecting participating sponsors. Comments will be accepted until May 29, 2026, with final selection criteria planned for July and pilot selections in August.
According to FDA Commissioner Marty Makary, M.D., M.P.H., real-time trials could significantly reduce delays in regulatory decision-making and help accelerate access to promising therapies. By allowing FDA scientists to monitor safety and efficacy signals continuously, the agency aims to move toward "continuous trials," reducing the downtime that typically occurs between discrete trial phases.
Chief AI Officer Jeremy Walsh noted that the initiative reflects a patient-centered approach: "We have to consider our processes from the standpoint of a patient awaiting a potentially powerful treatment."
The FDA says real-time clinical trials represent a foundational step toward a more efficient, data-driven drug development ecosystem- one that could ultimately shorten timelines and improve safety oversight across all phases of clinical research.
Courtesy: FDA
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