Cure8 research brief
Trial design affects how quickly and reliably new IBD treatments are tested and approved, and can influence patient experience (placebo exposure, retention) and whether trial populations reflect real-world patients.
Clinicians running or referring patients to trials, researchers and trial designers, and patient advocates interested in trial participation and policy.
The paper reviews four main trial design strategies: treat-through maintenance (keeps patients on study drug to assess durability), responder re-randomisation (separates induction and maintenance effects), Master Protocol approaches (basket, umbrella, platform trials to boost efficiency and reduce placebo exposure), and Bayesian methods (for stronger interpretation in early or complex trials).
It also highlights protocol-level choices such as co-primary endpoints, secondary/exploratory endpoints, control-group design, and use of digital health tools. The authors argue that strategic use of these methods can improve enrollment, reduce costs, and make trial results more applicable to real-world patients.
The article is a narrative review (abstract-level summary provided by PubMed); it synthesises design strategies rather than reporting new trial results.
This record is a narrative review (abstract-level content on PubMed). It summarises trial-design strategies rather than presenting original trial data or a systematic meta-analysis. Implementation details and outcomes of specific designs will vary by study and regulator.
Review the original publication for the complete reporting, methods, and context.
Conflict statement: Competing interests: PB received research grants from AbbVie, Amgen, Janssen, Mundipharma, Mylan, Pfizer and Viatris; receiving lecture fees from AbbVie, Janssen, Pfizer and Takeda; received advisory board fees from AbbVie, Arena Pharmaceuticals, Bristol Myers Squibb, Hospira, Janssen, Merck, Mundipharma, Pentax Medical, Pfizer, PSI CRO AG, Roche, Sandoz and Takeda; and received personal fees from AbbVie, Bristol Myers Squibb, Clinical Academic Group, Celltrion, Falk, European Pharma Group, Galapagos, Janssen, Lilly, Materia Prima, Pentax, Pfizer, Scope, Takeda, Arena, Circle Pharma Inc, Globalport, PSI CRO AG, Roche and Tetrameros. KM, KS, JZ and LMS are employees of PSI CRO AG.
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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