Cure8 research brief
If you have moderate–severe ulcerative colitis, this study suggests that typical phase III trials may exclude more than half of patients seen in specialty clinics, which can make trial results less representative of people treated in everyday practice.
Adult patients with moderate–severe UC, clinicians who refer patients to trials, clinical researchers designing IBD trials, and patient advocates focused on trial access and representation.
This abstract reports a retrospective cohort study of 150 adult patients with moderate–severe ulcerative colitis seen at a tertiary center (Jan 2022–Feb 2023). Investigators applied inclusion/exclusion criteria from seven phase III RCTs (2012–2022) to each patient and found only 42.7% would have been eligible for at least one trial.
The most common reasons for exclusion were prior or current medication use, anemia, dysplasia, and disease extent. The authors suggest broader inclusion criteria and more inclusive trial designs to improve external validity and representation.
The study is presented as an abstract of a journal article (structured content depth: abstract), so the summary reflects the provided abstract rather than a full-text trial report. The findings describe eligibility rates and exclusion reasons; they do not report effects of treatments or trial outcomes.
Practical takeaway: many real-world UC patients seen in specialty practice would not meet typical phase III RCT criteria, particularly because of prior medication exposure and common comorbidities, which can limit how directly trial results apply to routine clinical care.
This is a retrospective cohort analysis using eligibility criteria from several phase III trials and based on an academic tertiary-care population; results may differ in community settings. The article is provided as an abstract summary (not a full peer-review reproduction here).
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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