Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, University of Utrecht, Utrecht, The Netherlands.
Clin Pharmacol Ther. 2010 Sep;88(3):420-3. doi: 10.1038/clpt.2010.134. Epub 2010 Jul 28.
Noninferiority (NI) trials in drug research are used for the purpose of demonstrating that a new treatment is not worse than a proven active comparator, thereby indirectly showing that the treatment is effective. This article explains and addresses the complications in the interpretation of NI trials that arise from the indirect comparison. On the basis of our review of 232 trials, we conclude that the interpretation and inference of NI trials are complicated, partly because of the incompleteness of the information.
药物研究中的非劣效（NI）试验用于证明一种新的治疗方法不比已证实的有效对照药物差，从而间接表明该治疗方法有效。本文解释并解决了由于间接比较而导致的 NI 试验解释的复杂性问题。根据我们对 232 项试验的回顾，我们得出结论，NI 试验的解释和推断很复杂，部分原因是信息不完整。
