An international consensus on the design of clinical trials for advanced combination treatment (ACT) in inflammatory bowel disease.

ABSTRACT:

Background

Advanced Combination Treatment (ACT) refers to the dual use of two advanced therapies-either two biologics, two small molecules, or one biologic and one small molecule. There is a lack of guidance regarding clinical trial design for ACT in patients with inflammatory bowel disease (IBD). Key uncertainties remain regarding aspects such as eligibility criteria, pharmacotherapy regimens, safety considerations, and standardised trial design configurations for both induction and maintenance phases. We aimed to formulate expert recommendations regarding the design of ACT clinical trials in IBD.

Methods

A systematic search was performed in June 2023. Modified RAND/University of California, Los Angeles Appropriateness Methodology (RAM) was employed to evaluate 287 statemen

SUBMITTER: Solitano V 

PROVIDER: S-EPMC12593430 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature