The FDA is testing a new framework for monitoring safety signals as trials progress to reduce delays in therapeutic approvals.
RT’s Three Key Takeaways:
- Real-Time Data Signals: The US FDA has initiated proof-of-concept trials that allow scientists to monitor safety signals and endpoints as they occur rather than waiting for post-trial analysis.
- Expanded Pilot Program: The agency issued a request for information to help design a broader pilot program for real-time clinical trials that is expected to launch this summer.
- Continuous Trial Model: The initiative seeks to eliminate the traditional gaps between clinical phases to create a continuous development process that delivers therapies to patients more quickly.
The US FDA announced two steps to implement real-time clinical trials (RTCT) to increase efficiency and safety monitoring in drug development, according to the agency.
The agency has initiated proof-of-concept trials with AstraZeneca and Amgen. AstraZeneca is currently conducting a phase 2 trial, TRAVERSE, for patients with mantle cell lymphoma. Amgen is conducting a phase 1b trial, STREAM-SCLC, for patients with limited-stage small cell lung carcinoma, a study of particular interest to the respiratory healthcare sector.
“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,” said Marty Makary, MD, MPH, commissioner, in a news release.
The agency validated technical signals for the AstraZeneca trial through Paradigm Health, establishing the framework for real-time data sharing. To expand these efforts, the FDA released a request for information (RFI) to gather input on the design, metrics, and implementation of a broader pilot program.
Early-phase clinical trials are often a bottleneck in development due to high uncertainty, limited patient populations, and inefficient decision-making. By utilizing advancements in AI and data science, sponsors can now report data to the agency in real time.
“Real-time trials have been talked about for years. We demonstrated that it is not only possible, but also potentially transformative for the clinical trials ecosystem,” said Jeremy Walsh, chief AI officer, in a news release.
The transition to real-time trials is intended to facilitate “continuous” trials. Currently, clinical development occurs in discrete phases with a hiatus between each protocol. Real-time insights could eliminate these delays, allowing for a more seamless transition between study phases.
The FDA will accept comments on the RFI until May 29, 2026. The agency plans to release selection criteria in July and finalize pilot selections in August.
