More than half of real-world adult patients with moderate-to-severe ulcerative colitis (UC) are ineligible for current randomized controlled trials (RCTs), according to a study published online Aug. 4 in Crohn’s & Colitis 360.
Sandra Elmasry, M.D., from the Mayo Clinic Arizona in Scottsdale, and colleagues conducted a retrospective cohort study involving adults with moderate-to-severe UC seen between January 2022 and February 2023 to examine contemporary clinical trial eligibility in a tertiary care setting. To determine patient eligibility, inclusion and exclusion criteria for seven phase 3 RCTs conducted between 2012 and 2022 were applied.
The researchers found that only 42.7 percent of the 150 patients were eligible for at least one RCT. Current or prior medication use was the most common exclusion factor, followed by anemia, dysplasia, and extent of disease. No significant difference was seen in trial eligibility based on age, gender, or disease duration.
“Compared to results from 2012, our study findings demonstrate potential improvement with 42.7 percent of patients now considered trial-eligible for at least one study although there remains considerable potential for improvement to include a broader range of patients,” the authors write.
One author disclosed ties to the biopharmaceutical industry.
RCTs remain the gold standard for evaluating a new treatment’s efficacy and safety, but their highly selective enrollment criteria can limit external validity.
Patients seen in gastroenterology practice often have characteristics that would exclude them from clinical trials, including multiple comorbidities, prior biologic exposure, corticosteroid dependence, or complex disease histories.
As new treatments enter the market, clinicians may apply evidence generated in a relatively narrow patient population to a much broader, more heterogeneous group.
Understanding who was excluded from pivotal clinical trials can help clinicians better interpret efficacy, safety, and treatment sequencing data.
The study’s findings underscore the importance of shared decision-making and personalized treatment plans, particularly when evidence gaps exist for certain patient populations.
As the ulcerative colitis treatment landscape expands, clinicians may need to look beyond trial results and consider how closely study participants resemble the patients in their exam rooms.
Clinical trials often have strict eligibility criteria to improve internal validity. While this approach can strengthen the study design, it can create populations that differ substantially from patients seen in routine practice.
Historically, people from certain racial and ethnic groups have been underrepresented in many clinical trials across different illnesses and diseases. When eligibility criteria also exclude patients with common comorbidities, clinicians may have limited evidence to guide treatment decisions for diverse populations.
Real-world patients with ulcerative colitis frequently present with multiple chronic conditions, prior treatment failures, or complex medication histories. These characteristics often exclude them from randomized controlled trials. Real-world evidence studies, disease registries, and post-marketing surveillance can help fill knowledge gaps.
Clinicians will need to consider both clinical trial data and real-world outcomes when evaluating treatment options for patients with moderate-to-severe ulcerative colitis.
As gastroenterology moves toward personalized care, ensuring trial participants reflect the complexity and diversity of real-world patients will be critical to translating research findings into equitable clinical outcomes.
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