Non-Inferiority Trials in Stroke Research: What Are They, and How Should We Interpret Them?

Li L, Lioutas VA, Akyea RK, Gerner S, Lau KK, Ramage E, Katsanos AH, Howard G, Bath PM (2025)

Publication Type: Journal article, Review article

Publication year: 2025

Journal

Journal of Stroke Korean Stroke Society

Book Volume: 27

Pages Range: 41-51

Journal Issue: 1

DOI: 10.5853/jos.2024.03923

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.

Authors with CRIS profile

Stefan Gerner Department of Neurology

Involved external institutions

University of Oxford

United Kingdom (GB) Harvard University

United States (USA) (US) University of Nottingham

United Kingdom (GB) University of Hong Kong (HKU) / 香港大學

Hong Kong (HK) The Florey Institute of Neuroscience and Mental Health

Australia (AU) McMaster University

Canada (CA) University of Alabama at Birmingham (UAB)

United States (USA) (US)

How to cite

APA:

Li, L., Lioutas, V.A., Akyea, R.K., Gerner, S., Lau, K.K., Ramage, E.,... 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

MLA:

Li, Linxin, et al. "Non-Inferiority Trials in Stroke Research: What Are They, and How Should We Interpret Them?" Journal of Stroke 27.1 (2025): 41-51.

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