Department of Bioethics, Clinical Center, National Institutes of Health, 10/1C118, 10 Center Drive, Bethesda, MD 20892, United States; Fogarty International Center, National Institutes of Health, 16/210, Stone House, Bethesda, MD 20892, United States.
Contemp Clin Trials. 2013 Nov;36(2):510-4. doi: 10.1016/j.cct.2013.09.003. Epub 2013 Sep 12.
The use of placebo controls in clinical trials remains controversial. Ethical analysis and international ethical guidance permit the use of placebo controls in randomized trials when scientifically indicated in four cases: (1) when there is no proven effective treatment for the condition under study; (2) when withholding treatment poses negligible risks to participants; (3) when there are compelling methodological reasons for using placebo, and withholding treatment does not pose a risk of serious harm to participants; and, more controversially, (4) when there are compelling methodological reasons for using placebo, and the research is intended to develop interventions that can be implemented in the population from which trial participants are drawn, and the trial does not require participants to forgo treatment they would otherwise receive. The concept of methodological reasons is essential to assessing the ethics of placebo controls in these controversial last two cases. This article sets out key considerations relevant to considering whether methodological reasons for a placebo control are compelling.
安慰剂对照在临床试验中的使用仍然存在争议。伦理分析和国际伦理准则允许在以下四种情况下在随机试验中使用安慰剂对照：（1）当研究疾病没有经过证实的有效治疗方法时；（2）当不给予治疗对参与者造成的风险可以忽略不计时；（3）当出于强烈的方法学原因需要使用安慰剂，且不给予治疗不会对参与者造成严重伤害的风险时；以及更具争议性的是，（4）当出于强烈的方法学原因需要使用安慰剂，并且研究旨在开发可以在试验参与者所在人群中实施的干预措施，并且试验不需要参与者放弃他们本来会接受的治疗时。方法学原因的概念对于评估后两种情况下安慰剂对照的伦理问题至关重要。本文阐述了与考虑是否存在强烈的方法学理由来进行安慰剂对照相关的关键考虑因素。
