By Clinical Research News Staff

April 29, 2026 | The U.S. Food & Drug Administration is piloting real-time review of data from AstraZeneca and Amgen clinical trials, both using Paradigm Health's Study Conduct platform, and has issued a call for feedback on how artificial intelligence (AI)-enabled technologies can improve efficiency, speed, and quality of decision-making in early phase clinical trials. FDA has already received and validated signals for AstraZeneca’s trial and expects this to be the first step in implementing real-time clinical trials (RTCT).

“We are boldly advancing a modern approach whereby FDA scientists can view safety signals and endpoints in real time as a trial progresses,” said FDA Commissioner Marty Makary, M.D., M.P.H. in an FDA press release yesterday. “This will help us accelerate promising therapies, and build toward our ultimate goal of running real-time, continuous trials across all phases of drug development.” 

Paradigm Health’s platform is enabling real-time data review by the FDA, automating data collection and analysis and streamlining the reporting of key safety and efficacy signals concurrently to trial sponsors and the FDA. The new model has launched in an AstraZeneca-sponsored Phase 2 trial in patients with treatment-naïve mantle cell lymphoma and an Amgen-sponsored Phase 1b trial in patients with limited-stage small cell lung carcinoma. The AstraZeneca multi-site trial includes MD Anderson Cancer Center and Perelman School of Medicine at the University of Pennsylvania. FDA has already received and validated signals for AstraZeneca’s trial through Paradigm Health. The Amgen trial has not announced sites yet.

The Paradigm Health Study Conduct solution works by capturing data directly from electronic health records and other structured and unstructured sources, algorithmically evaluating FDA-defined data points and reporting criteria in real time, and transmitting only the critical signals and data needed for regulatory determinations to the trial sponsor and the FDA. Paradigm Health engineered the infrastructure specifically for the collaboration, working closely with the FDA to define reporting and validation protocols, establish criteria for key regulatory events, and ensure FDA-Paradigm Health software and data interoperability. The data transferred through the real-time platform is traceable, auditable, and protects patient privacy, while minimizing the transfer of patient data and other unnecessary datasets.

FDA Chief AI Officer Jeremy Walsh told Reuters that the initiative differs from existing data-sharing ‌frameworks ⁠because the FDA is not seeking access to raw patient records.

Expanding This Pilot

In order to build on these proofs-of-concept with a broader pilot program, FDA today released a Request for Information seeking input on potential pilot program design and implementation, as well as evaluation metrics and success criteria.

“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.”

According to the RFI, FDA seeks opportunities for AI and data science to improve trial efficiency, enhance safety monitoring, facilitate dose selection decisions, and enable more informed early go/no-go decisions (e.g., a regulatory decision as to whether a Phase 1 study may proceed) while maintaining FDA’s rigorous scientific and regulatory standards. The pilot program will be guided by principles aligned with the National Institute of Standards and Technology (NIST) AI Risk Management Framework (AI RMF).

The agency will accept comments on the RFI until May 29, 2026. The agency intends to disseminate final selection criteria in July and complete pilot selections in August.