Non-inferiority trials in stroke research: what are they, and how should we interpret them?

Li, Linxin; Lioutas, Vasileios-Arsenios; Akyea, Ralph K.; Gerner, Stefan; Lau, Kui Kai; Ramage, Emily; Katsanos, Aristeidis H.; Howard, George; Bath, Philip M.

Abstract

Randomized clinical trials are important in both clinical and academic stroke communities with increasing numbers of new design concepts emerging. One of the “less traditional” designs that have gained increasing interest in the last decade is non-inferiority trials. Whilst the concept might appear straightforward, the design and interpretation of non-inferiority trials can be challenging. In this review, we will use exemplars from clinical trials in the stroke field to provide an overview of the advantages and limitations of non-inferiority trials and how they should be interpreted in stroke research.

Citation

Li, L., Lioutas, V.-A., Akyea, R. K., Gerner, S., Lau, K. K., Ramage, E., Katsanos, A. H., Howard, G., & Bath, P. M. (2025). Non-inferiority trials in stroke research: what are they, and how should we interpret them?. Journal of Stroke, 27(1), 41-51. https://doi.org/10.5853/jos.2024.03923

• Journal Article Type: Article
• Acceptance Date: Dec 27, 2024
• Online Publication Date: Jan 31, 2025
• Publication Date: Jan 31, 2025
• Deposit Date: Jan 6, 2025
• Publicly Available Date: Jan 6, 2025
• Journal: Journal of Stroke
• Print ISSN: 2287-6391
• Electronic ISSN: 2287-6405
• Publisher: Korean Stroke Society
• Peer Reviewed: Peer Reviewed
• Volume: 27
• Issue: 1
• Pages: 41-51
• DOI: https://doi.org/10.5853/jos.2024.03923
• Keywords: Non-inferiority; Stroke; Trial design; Clinical trial; Methodology
• Public URL: https://nottingham-repository.worktribe.com/output/43948339
• Publisher URL: https://www.j-stroke.org/journal/view.php?doi=10.5853/jos.2024.03923
• Additional Information: Received: 2024-09-24; Accepted: 2024-12-27; Published online: 2025-01-31; Print publication: 2025-01-31