Methodology and initial results from a real-world observational cohort of patients with inflammatory bowel disease: TARGET-IBD
Authors: Laura DalfonsoJulie M. Crawford
View publication →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.
Use Cases / Links
Foundational real-world IBD registry infrastructure for advanced biologic and small molecule development, Multi-site prospective natural history and comparative effectiveness platform for Crohn's disease and UC, Registry infrastructure enabling pharma partnerships across the IBD treatment landscape