The Risks and Benefits of FDA Reviewing Real-Time 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: What are the benefits and risks of FDA reviewing real-time clinical data?
Dr. Richard Graham: I think the benefits are addressing a lot of inefficiency in the analysis and reporting phases. I think there is a benefit to FDA seeing the data sooner and there can be a benefit to using technology, such as artificial intelligence, to be able to aggregate data and look at signals and identify signals, whether that's on the safety side or the efficacy side.

What I think is also true, however, is that mistakes that happen at clinical trial sites and clinical research happen at the site when the visit is being conducted with the patient. My concern here is that looking at aggregated data earlier than otherwise may actually lead to spurious conclusions if the data that's coming in is not accurate.

So let me, let me say that a different way. I started a software company called True Technologies seven years ago, and I did that as a drug developer of 20-plus years at the time only because I had seen mistakes over and over and had several near misses with regulatory agencies myself.

Instead of really looking at the analysis and reporting stage, I went way upstream and solved a problem at the clinical trial sites, which is capturing data directly. As an industry, we overuse the term real time. And in this case, I would say with the FDA initiative that one of the questions I would have is: What does real time really mean?

Is that instant, or is it days, or even weeks? I think it's probably the latter. So again, for me, I think where it could fall short is if the data that's coming into the system, whatever the system is with this new initiative, if the data is coming into the system is not precise and not accurate, and you're looking at information that's a smaller sample size, as the trial is progressing, versus at the end of the study, you have a chance of making a spurious conclusion.

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