The Difference Between Real-Time Clinical Data Review and Real-Time Clinical Trial Oversite

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: What is the difference between real-time clinical data review and real-time clinical trial oversite?
Dr. Richard Graham: I'm reacting to what's made available from the FDA initiative, and there's probably devil in the details, maybe more to it. But I think real time data review, in my opinion, seems to be more about changing the timeframe from months to weeks or days, which is good. It's still an improvement.

But I think what I would maybe think about doing is stop over using the words “real time.” What I like to think about is direct data capture. When we're talking about the problems at the source at the clinical trial site, I think where the benefits could be to capture data directly at the source at the patient's bedside, and that's precise and accurate data.

Again, my concern is, as nice as it sounds to be able to look for signals earlier, when you look at signals earlier, meaning from a smaller subset of patients, you have the potential to come to an incorrect conclusion if those data are not exactly precise.

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