Real-World IBD Patients Rarely Meet Clinical Trial Criteria: AJG | June 2026

Introduction:

Randomized clinical trials (RCTs) are the cornerstone for approving biologic therapies in inflammatory bowel disease (IBD). However, strict eligibility criteria may exclude many patients encountered in routine clinical practice, raising concerns about the real-world applicability of trial results.

Why was this study needed?

The external validity of pivotal IBD clinical trials has not been well established. This study evaluated how many real-world patients would have qualified for landmark biologic trials and whether trial eligibility influenced treatment outcomes.

What did the study show?

• Only 16.9% of patients met eligibility criteria for pivotal biologic RCTs, falling to 8% using newer trial criteria.
• Disease-related exclusion criteria accounted for most ineligible patients.
• Patients with ulcerative colitis were significantly less likely to qualify for RCTs than those with Crohn's disease.
• Clinical response and remission rates were similar in trial-eligible and non-eligible patients.
• Adverse events and drug discontinuation rates did not differ between the two groups.
• Long-term treatment persistence was also comparable regardless of trial eligibility.

Clinical Impact:

These findings suggest that biologic therapies remain effective and safe in many patients who would have been excluded from clinical trials. Real-world evidence should complement RCT data when making treatment decisions and developing future clinical guidelines.

Take-Home Message:

Most patients treated with biologics for IBD would not qualify for pivotal clinical trials. Despite this, real-world effectiveness, safety, and treatment persistence are comparable, emphasizing that clinical judgment and real-world evidence are essential alongside randomized trial data.