Non-inferiority versus superiority drug claims: the (not so) subtle distinction
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چکیده
منابع مشابه
Non-inferiority versus superiority drug claims: the (not so) subtle distinction
BACKGROUND Current regulatory guidance and practice of non-inferiority trials are asymmetric in favor of the test treatment (Test) over the reference treatment (Control). These trials are designed to compare the relative efficacy of Test to Control by reference to a clinically important margin, M. MAIN TEXT Non-inferiority trials allow for the conclusion of: (a) non-inferiority of Test to Con...
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BACKGROUND Non-inferiority (NI) trials in drug research are used to demonstrate that a new treatment is not less effective than an active comparator. Since phase IV trials typically aim at informing a clinical decision, the value of a phase IV non-inferiority trial hinges also on its clinical relevance. In such trials, clinical relevance would refer to the added benefit claims of a specific dru...
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ژورنال
عنوان ژورنال: Trials
سال: 2017
ISSN: 1745-6215
DOI: 10.1186/s13063-017-2024-2