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 When I first started translating medical science documents, I realized I was fluent in French and English, but still had to learn the language of medical science. Over time, it turned out that I would learn more than medical terminology. See, clinical trials also incorporate statistical analysis, economics, ethics, and other subjects. At this time, I do generally see the same terms day in and day out, but new ones come to my attention regularly, too. Today, the term was non-inferiority margin (marge de non infériorité). My first instinct was to translate this word-for-word, but a little voice told me that would be too easy. Upon further research, it is quite commonly used with its counterpart the non-inferiority trial. This article explains the purpose of such a trial (and that it is different from a superiority trial), “As the name suggests, the aim is to show that the new treatment is not inferior to the existing one – that is, it is either equally effective or better. If this can be established, the new treatment can be considered as a replacement for the existing treatment, especially if it has other advantages (e.g. cost, safety) which make it preferable.”  Thus, the trial uses a margin, or pre-specified amount, to which the test drug and control are compared. If the effect of the test drug is not inferior to the effect of the control by that margin, then the test drug can replace the standard-of-care treatment.
The FDA and EMA go into great detail as to how to design and conduct non-inferiority trials and, of course, how to choose and apply the margin. This scientific article explains more generally, and in terms this translator can grasp, that “the margin should be defined based on the historical evidence of the active comparator (the latter is often the well‐established standard treatment of the disease), which can be performed by different approaches.” As a translator, I do not need to go into further detail (statistics make my brain vibrate). So, I will close by saying that it is always best to research new terms and ensure you are using the correct translation. Comments are closed.
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