WASHINGTON, D.C. — Federal regulators are moving to speed up drug development by launching real-time clinical trials that allow safety data and results to be reviewed as studies are underway instead of after they conclude.
What This Means for You
- New trial methods could bring treatments to patients faster
- Regulators will monitor safety data in real time during studies
- A broader pilot program is expected to launch later this year
The U.S. Food and Drug Administration announced two initial clinical trials using a new “real-time” model, alongside plans to expand the approach through a pilot program.
Real-time clinical trials allow researchers and regulators to share and review data continuously as it is generated, rather than waiting months or years for results to be compiled and submitted.
Why the Change Matters
Traditional clinical trials are conducted in phases, with data collected at study sites, analyzed by sponsors, and then submitted to regulators. This process can create delays between when data is generated and when decisions are made.
FDA officials said advances in artificial intelligence and data systems now make it possible to monitor trials as they happen, improving safety oversight and accelerating decisions.
“For 60 years, we’ve been conducting clinical trials in the same way, where key data signals can take years to reach the FDA,” said Commissioner Marty Makary. “We are advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses.”
Early Trials Underway
The agency confirmed two proof-of-concept trials are already in progress.
AstraZeneca is conducting a Phase 2 study involving patients with mantle cell lymphoma, while Amgen is running a Phase 1b trial focused on small cell lung cancer. In both cases, the FDA worked with sponsors to establish criteria for sharing safety signals and key data points in real time.
The agency said it has already received and validated data from AstraZeneca’s trial, demonstrating that the system can function as intended.
Toward Continuous Drug Development
Real-time trials are part of a broader shift toward what the FDA describes as “continuous” clinical trials — a model that reduces or eliminates gaps between study phases.
Currently, drug development is divided into separate stages, often with pauses between phases that can slow progress. Continuous trials would allow research to move forward without those delays.
FDA officials said this approach could shorten development timelines while maintaining safety standards.
Next Steps
The FDA has issued a Request for Information to gather public input on how to design a larger pilot program for real-time trials.
The agency will accept comments through May 29, 2026, with plans to finalize selection criteria in July and begin pilot program selections in August.
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