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

Author: Linxin LI ¹ ; Vasileios-Arsenios LIOUTAS ; Ralph K. AKYEA ; Stefan GERNER ; Kui Kai LAU ; Emily RAMAGE ; Aristeidis H. KATSANOS ; George HOWARD ; Philip M. BATH
Author Information

1. Wolfson Centre for Prevention of Stroke and Dementia, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK
Publication Type:Review
From:Journal of Stroke 2025;27(1):41-51
CountryRepublic of Korea
Language:English
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.