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随机临床试验中的利益冲突、选择性惰性与研究不当行为:邪恶三位一体。

Conflicts of Interest, Selective Inertia, and Research Malpractice in Randomized Clinical Trials: An Unholy Trinity.

作者信息

Berger Vance W

机构信息

National Cancer Institute and University of Maryland Baltimore County, Biometry Research Group, National Cancer Institute, 9609 Medical Center Drive, Rockville, MD, 20850, USA,

出版信息

Sci Eng Ethics. 2015 Aug;21(4):857-74. doi: 10.1007/s11948-014-9576-2. Epub 2014 Aug 24.

Abstract

Recently a great deal of attention has been paid to conflicts of interest in medical research, and the Institute of Medicine has called for more research into this important area. One research question that has not received sufficient attention concerns the mechanisms of action by which conflicts of interest can result in biased and/or flawed research. What discretion do conflicted researchers have to sway the results one way or the other? We address this issue from the perspective of selective inertia, or an unnatural selection of research methods based on which are most likely to establish the preferred conclusions, rather than on which are most valid. In many cases it is abundantly clear that a method that is not being used in practice is superior to the one that is being used in practice, at least from the perspective of validity, and that it is only inertia, as opposed to any serious suggestion that the incumbent method is superior (or even comparable), that keeps the inferior procedure in use, to the exclusion of the superior one. By focusing on these flawed research methods we can go beyond statements of potential harm from real conflicts of interest, and can more directly assess actual (not potential) harm.

摘要

最近,医学研究中的利益冲突问题受到了广泛关注,美国国家医学院呼吁对这一重要领域进行更多研究。一个尚未得到充分关注的研究问题是,利益冲突导致研究产生偏差和/或缺陷的作用机制。存在利益冲突的研究人员有多大的决定权来左右研究结果?我们从选择性惯性的角度来探讨这个问题,即基于哪种研究方法最有可能得出偏好的结论而非最有效,对研究方法进行非自然选择。在许多情况下,很明显,至少从有效性的角度来看,一种实际未被采用的方法优于正在使用的方法,而仅仅是惯性使得较差的方法得以使用,而排除了较好的方法,并非有任何严肃的观点认为现有方法更优(甚至相当)。通过关注这些有缺陷的研究方法,我们可以超越关于实际利益冲突可能造成危害的表述,更直接地评估实际(而非潜在)危害。

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