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.

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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.

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.

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