Preservation of effect and the regulatory approval of new treatments on the basis of non-inferiority trials
Preservation of effect and the regulatory approval of new treatments on the basis of non-inferiority trials
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DOI：
10.1002/sim.3073
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发表时间：
2008-02-10
影响因子：
2
通讯作者：
Jiang, Qi
中科院分区：
文献类型：
--
作者：
Snapinn, Steven;Jiang, Qi
基于主动对照非劣效性试验批准实验治疗的标准通常包括证明相对于主动对照的“效果保留”。虽然这表面上看起来是一个合理的标准，但经过仔细检查，可以发现它会导致严重的逻辑不一致。特别是，实验性治疗的临床试验结果可能优于标准治疗，但未能满足批准标准。在本文中，我们提出了一套有助于避免这些逻辑不一致的原则，并且我们认为，无论是否存在现有治疗方法以及用于评估治疗的研究设计类型，批准所需的实验治疗的质量都应该保持一致。版权所有 (C) 2007 John Wiley & Sons, Ltd.
The criteria for approval of an experimental treatment on the basis of active-controlled non-inferiority trials often include demonstration of 'preservation of effect' relative to the active control. While this appears on its surface to be a reasonable criterion, on closer inspection it can be shown to lead to serious logical inconsistencies. In particular, an experimental treatment may have clinical trial results that are superior to those for the standard treatment and yet fail to meet this criterion for approval. In this paper we propose a set of principles that will help avoid these logical inconsistencies, and we argue that the qualities of an experimental treatment that are required for approval should be consistent regardless of the presence or absence of existing treatments and the type of study design used to evaluate the treatment. Copyright (C) 2007 John Wiley & Sons, Ltd.