Contributed Commentary by Dr. Casey Chapman, GI Alliance 

June 6, 2025 | Gastroenterology is seeing meaningful progress in clinical research. New therapies for inflammatory bowel disease, colorectal cancer, and metabolic dysfunction-associated steatohepatitis (MASH) are being developed with increasing speed and precision. Yet for many community-based practices, participating in that research remains a significant challenge. 

While protocols are evolving and sponsor interest is strong, enrollment often lags behind. The root of the issue isn’t a lack of physician engagement. More often, it reflects the operational and logistical demands that make trial participation difficult to sustain in routine GI practice. 

Structural Barriers to Trial Activation 

Community practices typically operate without the infrastructure commonly found in academic settings. Many do not have full-time research staff or dedicated space for trial visits and specimen and product storage. Even when a research coordinator is on site, he or she is often managing other clinical or administrative duties. 

These resource constraints can lead to delays in activation. From the point of selection, a site may need several weeks before it’s able to begin enrollment. In that time, interested patients may move forward with other care options. Momentum fades, and opportunities are lost. 

Understanding Enrollment Challenges 

It’s easy to assume that slow enrollment means a lack of eligible patients. In practice, several other factors tend to play a larger role: protocols are often too complex, multiple studies may compete for similar patients, and trial awareness among patients is still low. 

Discussing research with patients requires more than eligibility screening. It takes time to explain the rationale, review risks and benefits, and build the kind of trust that supports informed participation. Finding that time in a busy GI clinic is one of the most persistent challenges. 

The Most Limited Resource: Time 

The most significant barrier to trial participation may simply be the lack of time. Physicians manage full clinics, perform procedures, and complete extensive documentation. Layering research tasks, such as feasibility assessments, meetings, and study oversight, into that environment is difficult without dedicated support. 

This is where a research team lead within the practice can make a measurable difference. Whether it’s a physician, a nurse, or a coordinator, having someone responsible for maintaining study momentum, team communication, and operational follow-through is essential. 

Making Partnerships Work 

Some practices have turned to external research partners to help manage logistics. When structured thoughtfully, these partnerships can reduce administrative burden and support consistency across trials. However, they are most effective when they complement—not replace—internal leadership and clinical engagement. 

The Role of Data and Technology 

Trial matching tools have become increasingly useful in ensuring that the right studies are placed at the right sites. By aligning protocol needs with factors including patient volume, disease focus, and team capacity, activation timelines and enrollment performance can improve. 

Artificial intelligence is also beginning to enhance certain aspects of study design and execution. Tools that support eligibility review, automate elements of disease scoring, or assist with data interpretation help reduce variability and improve reliability. With thoughtful use, these tools may also enable smaller, more efficient studies that retain statistical power while easing burden on sites. 

Start Small, Stay Focused 

For practices considering research expansion, the best starting point is alignment. Choose protocols that are clinically relevant to the patient population and reflect the interests of the care team. Begin with one or two well-suited trials to establish workflow, build confidence, and avoid unnecessary strain on resources. 

Sustainable growth in research comes from a strong foundation, not from volume alone. 

Looking Ahead 

To accelerate the delivery of new therapies in GI care, clinical research must be more accessible to the practices where patients are actually treated. That means writing protocols that reflect the pace and structure of real-world practice and involving practicing clinicians earlier in the design process. 

Research and care delivery can function in parallel. When supported with the right tools and planning, they become mutually reinforcing efforts that benefit both patients and providers. 

Dr. Casey Chapman is Chief Medical Officer at GI Alliance and a practicing gastroenterologist. He previously held roles at Gastroenterology Associates, Louisiana Endoscopy Center, and Baton Rouge General. Dr. Chapman earned his M.D. and B.S. from LSU and completed his residency and fellowship at LSU Health Sciences Center. He can be reached at JChapman@tddctx.com.