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Drug Discov Today. 2013 Jun;18(11-12):601-4. doi: 10.1016/j.drudis.2013.01.003. Epub 2013 Jan 14.

Should non-inferiority drug trials be banned altogether?

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  • 1Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences UIPS, Utrecht University, PO Box 80082, 3508TB Utrecht, The Netherlands.


Non-inferiority (NI) trials can be used in a situation when a new drug is expected to have a similar efficacy to its comparator but can offer other advantages over the existing drug, such as a more convenient method of administration or fewer side effects. Here, we discuss the advantages and disadvantages of NI trials from an ethical, methodological and regulatory perspective. We suggest that such trials should be designed to address simultaneously the objective of showing NI with regard to drug efficacy and the objective of establishing superiority of the additional advantages of a drug over its active comparator.

Copyright © 2013 Elsevier Ltd. All rights reserved.

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