FDA Announces Initiative to Improve Clinical Trial Efficiency with Real-Time Data Review

The Food and Drug Administration stated on April 28, 2026, that it would begin reviewing clinical trial data in real time to make the process more efficient. This starts with trials conducted by pharmaceutical companies AstraZeneca and Amgen. The agency reported these steps as part of broader efforts to streamline drug development.

AstraZeneca is running a Phase 2 trial of a combination therapy for patients with an aggressive form of lymphoma. The trial is set to occur at the University of Texas MD Anderson Cancer Center and the University of Pennsylvania. Amgen is conducting a Phase 1b trial of a treatment for small cell lung carcinoma.

trials will use a real-time data platform developed by Paradigm Health. This platform allows for ongoing data review during the studies. The FDA indicated that this approach could help identify issues earlier in the trial process.

The agency also requested public feedback on a potential pilot program. This program would involve companies using artificial intelligence to improve safety monitoring, select medication doses, detect safety signals, and enhance patient recruitment in clinical trials.

The FDA did not specify a timeline for implementing the pilot but noted it as a way to explore AI applications in drug development. Clinical trials are a key step in bringing new treatments to market, typically involving multiple phases to assess safety and efficacy.

Delays in data review can extend timelines and increase costs for drug developers. The FDA's initiative aims to address these challenges by incorporating technology for faster oversight.

The announcement comes amid ongoing discussions in the pharmaceutical industry about accelerating innovation. Real-time data review could reduce the time needed to advance promising therapies. The agency emphasized that these efforts would maintain standards for patient safety and data integrity.