FDA’s New Pilot Program and Real-Time Review of Clinical Data

In April, FDA announced plans for a pilot program to allow for real-time data review during clinical trials.¹ The program will allow for clinical trials to report endpoints and data signals as the data is recorded, which the agency says will significantly reduce timelines for the drug approval process.

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

Pharmaceutical Executive spoke with Tru Technologies chairman of the board Dr. Richard Graham about this program. While the full details of the program have yet to be made public, Graham was able to detail the value of real-time data collect, along with some of the challenges that reviewing data in this manner may present.

Pharmaceutical Executive: How does FDA's new pilot program enable real-time review of clinical data?
Dr. Richard Graham: Full disclosure, I’m familiar with the pilot program in terms of what's in the public domain, which I think relatively scratched the surface. It seems like a good initiative in the sense that it takes a lot of time to design studies, conduct studies, analyze data from studies, and report those studies. Those are the phases I like to think about.

My understanding of this initiative is really on the back end of that, in the analysis phase, because there's a lot of dead space in the process. And I think that's what that's what FDA had highlighted in their announcements, that relatively inefficient when data comes from a clinical trial site that goes to the sponsor.

The sponsor takes time to analyze the data, write clinical study reports, aggregate that across a bunch of studies, and ultimately turn that into a filing, whether that's an NDA or a BLA. Again, my understanding of the initiative is that FDA is trying to get rid of some of that dead space by having the data basically flow from the sites to the sponsor and FDA in parallel with a layer in between.

That layer in between is really meant to aggregate data and signals and give FDA ability to see those signals sooner than they would otherwise.

Source

1. FDA Announces Major Steps to Implement Real-Time Clinical Trials. FDA. April 28, 2026. Accessed May 15, 2026. https://www.fda.gov/news-events/press-announcements/fda-announces-major-steps-implement-real-time-clinical-trials