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Improving Enrollment for Inflammatory Bowel Disease Trials Through Site Network
By Allison Casey, Laurent Peyrin-Biroulet, MD, PhD — Last Updated: March 19, 2026
Laurent Peyrin-Biroulet, MD, PhD, describes the results of a study evaluating use of a site network to improve enrollment for inflammatory bowel disease (IBD) trials.
With the site network, there were improvements in overall randomization rates, median times from site selection to activation, activation to first patient screened, and activation to first patient randomized when compared with industry benchmarks. Of these improvements seen with the site network, Professor Peyrin-Biroulet concluded, “You accelerate innovation from the sponsor of the company, because they can do more, more trials … and for the patients, they will get quicker access to the drug.”
Transcript:
This transcript has been edited for clarity.
Laurent Peyrin-Biroulet, MD, PhD: Hello. I’m Laurent Peyrin-Biroulet. I’m Professor of gastroenterology and the European site network lead for Iterative Health.
Gastro Today: What are the primary drivers behind the decline in recruitment rates in IBD trials?
Dr. Peyrin-Biroulet: I would say two things: the operational burden and administrative steps. Everything takes time, and it’s a lot of burden for every site. Also, there is a lot of competition with a lot of trials.
Gastro Today: What were the methodology and results for this study?
Dr. Peyrin-Biroulet: This was very interesting because this was a study that included enrollment data from six phase 2 and phase 3 trials in IBD, and the idea was to evaluate what was the added value of this site network. As a benchmark, we used the literature data because a lot of things have been published. Then we assessed, during the six trials, what enrollment rate was observed, and we could compare the speed of enrollment with the literature.
There were 27 Iterative Health network sites in this study. In total, there are now more than 80 sites related to Iterative Health. Here, it was 27 sites, including 21 in the US and six in Europe. What was interesting is that this unique solution outperformed published industry benchmarks for patient randomization by an increase of 3.4-fold when compared to the average global randomization. What was seen was 0.34 patients per site per month [ie, a randomization rate of 0.34 overall] compared to published industry, which is currently around 0.1.
Gastro Today: How does this site network reduce operational burden?
Dr. Peyrin-Biroulet: What was interesting is that the sites were activated twofold faster, around 74 days, compared to published industry benchmarks, which is around 120 to 171 days. It’s 3 months of time-saving opportunity for biopharma sponsors. Why? Because you have a full package. Iterative Health is coming out with a solution with all steps before starting the trials. Administrative steps—everything that takes time—is reduced, and this is the reason why the solution is so effective.
Also, the site is dedicated and is aware of the Iterative Health solution, and it’s a strong partnership. Usually, we’re changing people—every time working with new people, restarting everything—which takes a lot of time. This time, you have the entire package in this unique solution.
Gastro Today: Which elements of the network contributed to the improvements seen in this study?
Dr. Peyrin-Biroulet: The main problem is two points. You have the operational burden. For this site to start and start again for every trial, it’s a lot of work every time for the team. What we need for the team—because now they have so many ongoing trials—is to decrease this burden. By helping, facilitating, reducing all these steps related to the operational burden, you accelerate everything. For the centers, they can be dedicated to including patients.
The other point is that there is a lot of discussion between Iterative Health and the centers. To enroll patients, you need to know everything. As physicians and investigators, we have many things to do. We have many things to think about. Here, you don’t need to think anymore. You just need to think about what is the best way to get quick access to innovation for patients. This is what we are looking at because at the end, even if you have cost savings for the sponsor, huge cost savings, also there is quicker access to innovation for the patients. When we have several trials, when we see a patient every day at the clinic, we don’t think about which trial, and sometimes we forget some trials. Now, everything is identified with a solution. This is a journey, and when you enter, it will be quick, fast, easy to use, and efficient.
Gastro Today: Is this network approach reproducible and scalable?
Dr. Peyrin-Biroulet: The main problem, as always, is that it takes a lot of time to embark all these sites, see all these patients, to develop the whole solution. It’s the reason why, now that it’s in place after several years of work, you know that it works. It took time to set up the solution. We are improving it every day, because as always, everything has to be improved, and everything has to evolve.
What is nice is that even if you have cultural differences, even if you have differences across the globe, we know that this solution can be used in every site across the globe. Otherwise, if you have to adapt to every center, to every trial, and so on, it makes it much longer. This is nice in terms of it can be used everywhere very easily, but you have to be part of the Iterative Health network.
Gastro Today: Is this model applicable beyond IBD?
Dr. Peyrin-Biroulet: This is a very good question. My simple answer would be yes, but every disease, everything is different. I know that the company is already working on other diseases. Yes, I think that this could be applied to every disease, when you look at the solution after several years of work with all these skills and so on. Yes, the goal is to expand beyond IBD, and it’s already the case with other diseases. Even if every disease is different, clearly with this innovative solution, we can look beyond IBD and the other diseases that are already on board at the company.
Gastro Today: How could faster enrollment impact trial costs, drug development timelines, and patient access to therapies?
Dr. Peyrin-Biroulet: From my point of view and as a physician, it’s very tough because some patients have refractory, difficult-to-treat disease. Even if sometimes surgery is a good option, we prefer avoiding surgery, or we prefer that the patient has a quick return to a good quality of life and a normal life. Every month that will be spared and that the patient will get access—not in August 2027 but in January 2027—from a patient perspective, is fantastic.
Also, if you take the sponsors’ perspective, every trial is a lot of money. When they have cost savings, thanks to this solution, they can invest more in other clinical trials, in other drug development programs, because if you go quicker, you can save millions of dollars. The estimate is something that is quite easy to calculate, but every month matters. You accelerate innovation from the sponsor of the company because they can do more, more trials at the same time and quicker, and for the patients, they will get quicker access to the drug. It’s something that is quite interesting from that point of view.
Gastro Today: Is there anything else you would like to add?
Dr. Peyrin-Biroulet: We knew something was missing. It’s missing more and more. Every year, we were under pressure. Now, we are delighted to say that there is this unique Iterative Health solution that was created, and now we are happy for the field, for IBD, but also, for sure, for all diseases.
References
Peyrin-Biroulet L, et al. J Crohn’s Colitis. 2026;20(suppl_1). doi: 10.1093/ecco-jcc/jjaf231.1154