Abstract
Background:
Non-inferiority (NI) trials aim to show a new treatment is no worse than a comparator. These trials have additional complexities in the design and analysis when compared with the more common superiority trials and these complexities can create confusion with researchers completing these trials.
Guidance is available for best practice of NI trials, however most of these focus on industry-funded trials as this is where much of the research has been to date. However, with this increase of more treatments being used in practice within the NHS, NI trials are becoming more common as the benefit of the new treatment is not always the main health outcome but instead a secondary outcome for example side effects. Research suggests there may be differences in the design of industry and publicly funded NI trials and many of the current reviews of NI trials are heavily influenced by industry-funded trials. This creates a gap in the literature to understand how publicly funded NI trials are being designed and how the guidance is translating to this different setting.
Methods: The International Standard Randomised Controlled Trial Number (ISRCTN) web registry and the National Institute for Health Research’s (NIHR) Funding and Awards Library and Journals Library were searched using the term non-inferiority and logical synonyms.
Characteristics of the design, analysis and results, as available, were recorded on a dedicated data extraction spreadsheet.
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