Clinical trials are typically seen as engines of innovation, but for economically disadvantaged individuals, they can also be a gateway to care—particularly for chronic diseases that are expensive to manage. For those living with gastrointestinal (GI) conditions like ulcerative colitis, Crohn’s disease, nonalcoholic fatty liver disease (NAFLD), or NAFLD’s advanced form, nonalcoholic steatohepatitis (NASH), clinical trials may offer access to diagnostics, treatments, and specialists that would otherwise be out of reach.
A Critical Gap in GI Care
GI diseases are rising in prevalence and cost. According to the Centers for Disease Control and Prevention, more than 3 million U.S. adults have been diagnosed with inflammatory bowel disease (IBD), which includes Crohn’s and ulcerative colitis, with healthcare costs exceeding $14.9 billion annually. Yet, treatment options are expensive, and coverage gaps leave many patients without consistent care.
For liver diseases like NAFLD and NASH, which disproportionately affect people with obesity and diabetes, the stakes are also high. Most patients with these conditions are unaware they have them until late stages, and many don’t receive timely or specialized treatment due to a lack of access.
How Clinical Trials Help GI Patients
- Early Diagnosis and Monitoring
Many GI trials include extensive diagnostic imaging, bloodwork, and liver function tests that participants might not otherwise afford or access—particularly in underserved communities where gastroenterology specialists are scarce.
- Access to Biologic and Advanced Therapies
New biologic drugs for IBD and antifibrotic agents for NASH are rapidly evolving but cost thousands of dollars per year. Clinical trials allow participants to access cutting-edge treatments without out-of-pocket costs. These treatments can prevent disease progression and dramatically improve quality of life.
- Breaking Down Cost Barriers
Clinical trials typically cover not only the investigational drug, but also doctor visits, endoscopic procedures, colonoscopies, and follow-up imaging. For conditions like Crohn’s or NASH—where frequent monitoring is standard—this can mean tens of thousands of dollars saved.
What Participants Receive in GI Clinical Trials
- Colonoscopies and endoscopies
- Liver enzyme panels and imaging (e.g., FibroScan, MRI-PDFF)
- Biologic or investigational drug therapies
- Dietitian and lifestyle coaching (select trials)
- Routine monitoring labs and follow-up visits
- Transportation or travel reimbursements (sometimes)
Note: Coverage varies by study protocol. Always confirm details with the site coordinator.
Addressing Underrepresentation in GI Trials
Despite high prevalence, low-income and minority populations remain underrepresented in GI clinical trials. According to a 2022 analysis in Gastroenterology, Black and Hispanic patients make up less than 15% of IBD trial populations, though they represent a growing segment of the affected population (see Figure 1).
This underrepresentation means treatment protocols may be less effective or carry unforeseen risks in diverse populations. Expanding access isn’t just ethical—it’s a scientific necessity.
Figure 1:
Source: Adapted from Gastroenterology, 2022
Solutions for Inclusive GI Research
- Community Gastroenterology Partnerships: Collaborating with Federally Qualified Health Centers and community clinics helps identify patients with GI conditions earlier and refer them into trial pipelines.
- Mobile FibroScan and Lab Units: Bringing non-invasive diagnostic tools into community settings lowers the barrier to entry for NASH/IBD trials.
- Bilingual Outreach and Cultural Competence: GI symptoms can be stigmatized, especially in immigrant communities. Tailoring outreach in multiple languages with sensitivity to cultural norms improves participation.
Conclusion
For patients battling complex, chronic GI diseases, clinical trials are more than research—they’re often the only realistic option for high-quality care. By opening the doors wider to economically disadvantaged and underrepresented populations, the clinical research community can provide earlier intervention, better outcomes, and more equitable science.
As the field of gastroenterology rapidly evolves, ensuring access to these innovations shouldn’t depend on a patient’s income or ZIP code. With intentional outreach, inclusive trial design, and community-based partnerships, clinical trials can—and should—be a safety net for those who need it most.
References
- Centers for Disease Control and Prevention. Inflammatory Bowel Disease Data and Statistics. https://www.cdc.gov/ibd/data-statistics.htm
- Journal of Hepatology. Recruiting Underrepresented Populations in NASH Trials: A Feasibility Analysis.
- Gastroenterology. Disparities in Clinical Trials for Inflammatory Bowel Disease. https://www.gastrojournal.org/article/S0016-5085(22)00214-6/fulltext
Contributed by Scott W. Ward, BS, CCRP, CT-C, ACRP-CP, Clinical Research Manager at Integrity Advanced Therapeutics, Houston, Texas.
Edited by Gary Cramer