J Stroke.
2025 Jan;27(1):41-51. 10.5853/jos.2024.03923.
Non-Inferiority Trials in Stroke Research: What Are They, and How Should We Interpret Them?
- Affiliations
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- 1Wolfson Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK
- 2Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA
- 3Centre for Academic Primary Care, Lifespan & Population Health Unit, School of Medicine, University of Nottingham, Nottingham, UK
- 4Department of Neurology, University Hospital Erlangen, Germany
- 5University of Hong Kong, Hong Kong, China
- 6Florey Institute of Neuroscience and Mental Health, Victoria, Australia
- 7McMaster University/Population Health Research Institute, Hamilton, ON, Canada
- 8University of Alabama at Birmingham, Birmingham, AL, USA
- 9Stroke Trials Unit, Mental Health & Clinical Neuroscience, University of Nottingham, Nottingham, UK
- KMID: 2564261
- DOI: http://doi.org/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.
