The US FDA announced on April 28 that it has successfully initiated two proof-of-concept studies designed to transmit trial endpoints and data signals to the agency in real time, naming AstraZeneca and Amgen as the first sponsors to participate in what the agency is calling real-time clinical trials (RTCTs). The announcement also included a Request for Information for a broader pilot program planned to launch this summer, according to the FDA press release. The initiative signals a shift toward earlier regulatory visibility into trial data, with potential implications for safety monitoring and development timelines.
AstraZeneca is conducting the Phase II multi-site TRAVERSE trial in patients with treatment-naïve mantle cell lymphoma, with sites at The University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is running the Phase Ib STREAM-SCLC trial in patients with limited-stage small cell lung carcinoma, though the FDA noted that final site selection for that study remains in process. The FDA stated it had already received and validated real-time signals from the TRAVERSE trial through a data intermediary called Paradigm Health, which the agency described as establishing the technical feasibility of the framework. No clinical efficacy or safety outcome data were reported for either trial, and the specific investigational drugs under evaluation in both studies were not disclosed in the announcement.
The RTCT model is intended to replace the conventional data flow in which information moves from trial sites to sponsors before eventual submission to the FDA, a sequence the agency said can introduce delays of years before key signals reach regulators. Under the RTCT framework, the FDA meets with sponsors in advance to define criteria for real-time signal reporting, and validated data are then transmitted to the agency as the trial progresses. The FDA did not disclose enrollment figures, dosing details, primary endpoints, blinding status, or Data Safety Monitoring Board arrangements for either the TRAVERSE or STREAM-SCLC studies in this announcement.