Methodology and initial results from a real-world observational cohort of patients with inflammatory bowel disease: TARGET-IBD.

Challenge

Advanced IBD drug development required a large-scale, prospective, longitudinal real-world registry with the depth of clinical, endoscopic, biomarker, and patient-reported data needed to generate comparative effectiveness evidence for the expanding landscape of biologic and small molecule therapies.

Solution

The TARGET-IBD registry was designed and launched as a prospective longitudinal observational cohort of adult and pediatric IBD patients at 34 academic and community US sites, with centrally abstracted electronic health records, quarterly PROs, and an annual biospecimen repository.

Impact

Establishing the TARGET-IBD registry created the foundational real-world infrastructure for all subsequent IBD treatment pattern, safety, effectiveness, and natural history studies, directly enabling partnerships with AbbVie, Bristol Myers Squibb, Merck, and other sponsors across the expanding IBD therapy landscape.