Speed has become one of the most decisive factors in modern drug development. Yet while sponsors and CROs invest heavily in trial design and innovation, execution often stalls at the site level. Long activation timelines, low enrollment rates, and investigator burnout continue to slow progress—especially in chronic diseases like inflammatory bowel disease (IBD), where patients cannot afford to wait.
In a recent Clinical Leader guest column, Dr. G. Aaron DuVall, founder and principal investigator at Tyler Research Institute (TRI), offers a compelling perspective on a solution that is hiding in plain sight: specialized community-based research sites.
Read the full article in Clinical Leader.
A System Under Strain
Today’s site-based research model is showing cracks. Industry-wide data paints a sobering picture:
- Site activation routinely takes six months or more
- Fewer than 50% of activated sites enroll a single patient
- Nearly two-thirds of principal investigators participate in only one trial before exiting research entirely
This churn is unsustainable—particularly for diseases like Crohn’s disease and ulcerative colitis, where trial delays directly translate into delayed access to potentially life-changing therapies.
As Dr. DuVall argues, the bottleneck is not a lack of willing patients or motivated physicians. It’s a mismatch between how trials are operationalized and how care is actually delivered in the real world.
Why Specialized Community Sites Enroll Faster
Community-based research sites embedded in specialty practices are uniquely positioned to outperform traditional models. These sites are not built around episodic trials—they are built around longitudinal patient care.
At Tyler Research Institute, this model has translated into measurable results. In a recent Phase 2 IBD trial, TRI screened six patients within two weeks of activation—far outperforming industry benchmarks that often exceed 75 days. Across a county of roughly 110,000 people, TRI has randomized more than 100 patients into IBD Phase 2–3 trials in just a few months, with screen failure rates under 15%.
These outcomes are driven by:
- Deep access to disease-specific patient populations
- Dedicated, on-site regulatory and operational teams
- Repeatable, trial-ready infrastructure
- Staff who are fully integrated into patient care pathways
When research is woven into everyday clinical practice, enrollment becomes a natural extension of care—not a parallel process.
Expanding Access for Underserved Patients
One of the most powerful insights from Dr. DuVall’s article is that community research sites do more than accelerate trials—they expand access.
For many patients with IBD, biologic therapies are financially out of reach. Clinical trials conducted in community settings can become the only realistic path to advanced treatment for uninsured or underinsured populations. In this context, research is not abstract—it is care.
Dr. DuVall shares the story of a patient with a 17-year history of severe ulcerative colitis whose participation in a clinical trial enabled her to return to school, rejoin the workforce, and fully re-engage with her family. These outcomes underscore a critical truth: when trials are brought closer to home, their impact extends well beyond endpoints and datasets.
Trust, Retention, and Better Data
IBD is a lifelong disease. Many patients cycle through multiple therapies, and clinical trials often span years. In this reality, trust and continuity matter.
Community-based research teams build long-term relationships with patients, which leads to:
- Higher retention rates
- Fewer protocol deviations
- Cleaner, more reliable data
These benefits are not incidental—they are structural. When the same physicians and coordinators support patients through both clinical care and research participation, the trial experience becomes more stable and humane.
Infrastructure Is the Difference Between Vision and Scale
While physician dedication is essential, it is not enough. Sustainable community research requires a scalable operational foundation—covering regulatory compliance, quality systems, staffing, contracting, and training.
At TRI, this has been achieved through collaboration with a broader research network that centralizes and strengthens operational functions. This model enables community sites to support specialized roles—regulatory staff, laboratory teams, coordinators, and pharmacists—without sacrificing independence or clinical focus.
For sponsors, the implications are clear. Rather than spreading resources across dozens of low-enrolling sites, partnering with high-performing community networks delivers faster startup, stronger enrollment, and higher-quality data with less administrative burden.
A Blueprint for the Future of Clinical Trials
As academic centers struggle with inefficiency and investigator shortages, specialized community research sites are emerging as a scalable alternative. They combine speed with quality, access with trust, and innovation with real-world care delivery.
Dr. DuVall’s perspective highlights what many in the industry are beginning to recognize: the future of efficient, patient-centered research depends on empowering community-based sites with the infrastructure, partnerships, and trust they need to succeed.
At Iterative Health, we see this model in action every day. By supporting community research programs like Tyler Research Institute, we believe clinical trials can move faster, reach broader populations, and ultimately deliver better outcomes—for sponsors and, most importantly, for patients.
Read the full article in Clinical Leader.
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. Today, Iterative Health is based in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.
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