The FDA is changing how clinical trials work after 60 years of the same approach. The agency announced today that it has successfully launched two real-time clinical trials that send safety and effectiveness data directly to regulators as the studies progress, rather than waiting months or years for final results.

This represents a major shift in drug development that could dramatically speed up how quickly new treatments reach patients. The agency also released a request for information about a broader pilot program launching this summer that could expand real-time trials across the industry.

Traditional clinical trials create significant delays in drug development. Data typically flows from trial sites to drug companies, which then analyze the information and submit reports to the FDA. This process can take years, even when early signals show a treatment is working or causing safety concerns.

“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 FDA Commissioner Marty Makary. “We are boldly advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses.”

The change comes at a critical time for the pharmaceutical industry. Early-phase clinical trials often struggle with small patient populations and slow decision-making processes. Meanwhile, advances in AI and data science now make it technically feasible to process and share trial data in real time.

Two major pharmaceutical companies are already testing the new approach:

• AstraZeneca is running a Phase 2 trial called TRAVERSE for patients with treatment-naive mantle cell lymphoma, involving MD Anderson Cancer Center and University of Pennsylvania
• Amgen is conducting a Phase 1b trial called STREAM-SCLC for patients with limited-stage small cell lung carcinoma

The FDA has already received and validated real-time data signals from AstraZeneca’s trial through a platform called Paradigm Health, proving the technical framework actually works.

The broader implications extend beyond just faster data sharing. Real-time trials could eliminate the lengthy gaps between different phases of drug development. Currently, companies typically run separate studies for Phase 1, Phase 2, and Phase 3 trials, with months-long delays between each phase as they analyze data and design the next study.

“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 Chief AI Officer Jeremy Walsh. “We have to consider our processes from the standpoint of a patient awaiting a potentially powerful treatment.”

The FDA’s ultimate goal is “continuous trials” where promising treatments can move seamlessly from early safety testing to larger effectiveness studies without the current stop-and-start approach. This could be particularly important for cancer treatments and other therapies where patients have limited time.

The agency is now seeking industry input on how to design a broader pilot program. Comments on the request for information are due by May 29, 2026. The FDA plans to announce final selection criteria in July and complete pilot selections in August.

The initiative represents one of the most significant changes to clinical trial regulation in decades. If successful, it could reshape how the entire pharmaceutical industry develops new drugs and medical devices.