Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences UIPS, Utrecht University, PO Box 80082, 3508TB Utrecht, The Netherlands.
Drug Discov Today. 2013 Jun;18(11-12):601-4. doi: 10.1016/j.drudis.2013.01.003. Epub 2013 Jan 14.
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.
非劣效（NI）试验可用于以下情况：新药预期具有与对照药物相似的疗效，但相对于现有药物具有其他优势，例如更方便的给药方式或更少的副作用。在这里，我们从伦理、方法学和监管的角度讨论了 NI 试验的优缺点。我们建议，此类试验的设计应同时解决显示药物疗效的 NI 目标和确立药物相对于其活性对照药物的附加优势的优越性目标。
