Cure8 research brief
A platform trial could evaluate multiple advanced therapies and combinations more efficiently, which matters for people with refractory Crohn's disease who have already tried several advanced treatments.
Consensus around populations, comparators, and outcomes helps align trial design with patient and clinician priorities.
Clinicians and trialists designing IBD trials, researchers interested in adaptive platform designs, patients with refractory Crohn's disease (especially those exposed to multiple advanced therapies), and funders of clinical research.
The study used a two-stage modified Delphi process with clinicians, trialists, allied health professionals and patients to reach consensus thresholds (≥70%).
Patients with prior exposure to two or more advanced therapy classes were prioritised as the target population, and there was strong support for testing multiple mechanistic classes and combination advanced-therapy strategies.
Stakeholders emphasised using objective measures (endoscopy, imaging, biomarkers), central reading, and standardised assessment timepoints, and selected clinical remission as the preferred primary outcome with support for composite endpoints incorporating endoscopic response at 48 weeks.
These results are intended to inform subsequent protocol development for a platform trial rather than to define a final trial design.
This article reports consensus from a Delphi process (abstract-level summary). The results provide a foundation for protocol development but do not represent a finalized trial; further methodological work and protocol peer review will be needed before a trial is launched.
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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