Placebo orthodoxy in clinical research .2. Ethical, legal, and regulatory myths
Placebo orthodoxy in clinical research .2. Ethical, legal, and regulatory myths
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DOI：
10.1111/j.1748-720x.1996.tb01860.x
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发表时间：
1996-09-01
影响因子：
2.1
通讯作者：
Weijer, C
中科院分区：
文献类型：
--
作者：
Freedman, B;Glass, KC;Weijer, C
安慰剂对照试验被许多人，包括美国食品和药物管理局（FDA）等机构的监管机构，作为评估新医疗干预措施的黄金标准。然而，在临床试验中使用安慰剂对照一直是相当大的争议的焦点。在这篇由两部分组成的文章中，我们挑战了一些关于安慰剂对照价值的常见信念。第一部分批判了在临床研究中使用安慰剂对照的统计学和其他科学依据。在已有公认治疗方法的疾病的临床试验中继续使用安慰剂对照，会引起同样重要的伦理、法律的和监管问题，对此有各种理由。对这种做法的辩护依赖于规范性和经验性的神话。在对安慰剂对照的普遍使用的攻击中，肯尼斯·罗斯曼和卡琳·米歇尔斯强调，这种做法违反了世界医学协会关于人体实验伦理的指导方针，最常见的是赫尔辛基宣言。
Placebo-controlled trials are held by many, including regulators at agencies like the United States Food and Drug Administration (FDA), to be the gold standard in the assessment of new medical interventions. Yet the use of placebo controls in clinical trials has been the focus of considerable controversy. In this two-part article, we challenge a number of common beliefs concerning the value of placebo controls. Part I critiques statistical and other scientific justifications for the use of placebo controls in clinical research. The continued use of placebo controls in clinical trials on diseases for which accepted treatment exists raises equally important ethical, legal, and regulatory issues for which various justifications have been given. Defense of this practice relies on normative as well as empirical myths.In their attack on the prevailing use of placebo controls, Kenneth Rothman and Karin Michels emphasize that this practice stands in violation of the World Medical Association's guidelines on the ethics of human experimentation, most commonly known as the Helsinki Declaration.