ESOC 2026 | Non-inferiority trials in stroke research: when is this study design most appropriate?
Aristeidis Katsanos, MD, PhD, McMaster University, Hamilton, Canada, discusses the role of non-inferiority trials in stroke research and outlines when this study design is most appropriate. He highlights key tenecteplase trials demonstrating non-inferiority to alteplase, findings that ultimately helped shift clinical practice and influenced current standards of care. This interview took place at the 12th European Stroke Organisation Conference (ESOC) in Maastricht, The Netherlands.
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Transcript
Yeah, so non-inferiority trials are becoming more and more common in stroke. So to go for a non-inferiority trial, what you actually need is to have a treatment that has advantages over the standard of care. So what you’re actually doing in a non-inferiority trial, so in order to accept those advantages that a new treatment may have, you set up a margin and the margin is the acceptable loss that you have in the efficacy that you’re willing to take given the advantages that this treatment may have so they’re becoming more and more common especially in hyperacute stroke care and the prime example is tenecteplase so all of the tenecteplase trials were based on non-inferiority design they were proven that tenecteplase was non-inferior to alteplase and that’s changed the standard of care now...
Yeah, so non-inferiority trials are becoming more and more common in stroke. So to go for a non-inferiority trial, what you actually need is to have a treatment that has advantages over the standard of care. So what you’re actually doing in a non-inferiority trial, so in order to accept those advantages that a new treatment may have, you set up a margin and the margin is the acceptable loss that you have in the efficacy that you’re willing to take given the advantages that this treatment may have so they’re becoming more and more common especially in hyperacute stroke care and the prime example is tenecteplase so all of the tenecteplase trials were based on non-inferiority design they were proven that tenecteplase was non-inferior to alteplase and that’s changed the standard of care now. So in most parts of the world now tenecteplase has replaced alteplase.
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