Click here to read the peer-reviewed journal article on the Journal of Crohn’s and Colitis website.
Recruitment challenges in inflammatory bowel disease (IBD) trials are not new, but recent data reveal that enrollment rates have declined dramatically over the past two decades. Randomized controlled trials (RCTs) in ulcerative colitis (UC) and Crohn’s disease (CD) now average far fewer patients per site per month than they did in 1998, prolonging trial timelines, increasing costs, and delaying patient access to potentially life-changing therapies.
In a new publication in the Journal of Crohn’s and Colitis, Dr. G. Aaron DuVall and colleagues highlight how an innovative, network-based approach to site selection can meaningfully improve trial performance. The study, conducted across Phase 2 and 3 RCTs between April 2024 and October 2025, provides compelling evidence that a coordinated, operationally supported site network accelerates patient enrollment while maintaining high data quality.
The Problem: Operational Bottlenecks Slow Trials
Clinical trials demand more than willing patients—they require sites equipped to handle regulatory documentation, training, budgeting, and prescreening workflows. These administrative burdens contribute to slow site activation, delayed first-patient enrollment, and underperformance across multicenter trials. Traditional site models often leave physicians juggling care and research, which can limit both recruitment efficiency and patient retention.
The Network Solution
By integrating sites into a global gastroenterology trial network, the study demonstrated measurable improvements:
- Faster activation: Median time from site selection to activation was 74 days, faster than industry benchmarks of 122–171 days.
- Rapid first patient enrollment: Median time from activation to first patient screened was 45 days.
- Accelerated randomization: Median time to first patient randomized was 83 days, significantly better than the 140-day benchmark.
- Higher enrollment rates: The network achieved a weighted average randomization rate of 0.34 patients per site per month—over three times higher than 2020 benchmarks.
These outcomes were consistent across both UC and CD trials, as well as across Phase 2 and Phase 3 studies, showing that network-supported sites can reliably deliver faster, higher-quality trial execution.
Why This Approach Works
The key to success lies in embedding research infrastructure directly into clinical practice:
- Standardized operational support: Centralized systems handle regulatory, contracting, and quality functions, freeing site staff to focus on patient care and recruitment.
- Study-specific training: Coordinators and physicians are prepared to execute trials efficiently from day one.
- Technology-enabled patient identification: Tools streamline prescreening and enhance enrollment efficiency.
- Continuity of care: Sites build long-term relationships with patients, increasing retention and ensuring cleaner, more reliable data.
This model transforms trials from episodic, burdensome projects into a seamless extension of clinical care. Patients benefit from faster access to investigational therapies, while sponsors gain higher-performing, predictable sites.
A Blueprint for the Future
The study underscores a larger trend: community-based and network-integrated research sites represent a scalable, sustainable solution to the longstanding enrollment challenges in IBD trials. By combining operational excellence, patient-centered care, and network-wide coordination, this approach accelerates trial timelines and improves outcomes for everyone involved—patients, investigators, and sponsors alike.
At Iterative Health, we see this model in action every day, supporting community research programs and helping trials move faster while reaching broader populations. The implications are clear: smarter site networks are not just a temporary fix—they are the future of efficient, patient-centered clinical research.
Click here to read the peer-reviewed journal article on the Journal of Crohn’s and Colitis website.
About Iterative Health
Iterative Health is a healthcare technology and services company powering the acceleration of clinical research to transform patient outcomes. By combining deep expertise in clinical trials with cutting-edge AI, we empower research teams and study sponsors to expand and expedite access to novel therapeutics for patients in need. The company has headquarters in Cambridge, Massachusetts, and New York, New York. For more information, visit www.iterative.health and follow us on LinkedIn for the latest company updates.
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