Hey Spencer Phillips, Weijer Charles
Division of Pharmacoepidemilogy and Pharmacoeconomics, Brigham and Women's Hospital, Harvard Center for Bioethics, Harvard Medical School, Boston, MA, USA.
Rotman Institute of Philosophy, Western University, Stevenson Hall 2150c, London, ON N6A 5B8, Canada.
Monash Bioeth Rev. 2016 Mar;34(1):23-36. doi: 10.1007/s40592-016-0057-z.
The concept of clinical equipoise restricts the use of placebo controls in clinical trials when there already exists a proven effective treatment. Several critics of clinical equipoise have put forward alleged counter-examples to this restriction-describing instances of ethical placebo-controlled trials that apparently violate clinical equipoise. In this essay, we respond to these examples and show that clinical equipoise is not as restrictive of placebos as these authors assume. We argue that a subtler appreciation for clinical equipoise-in particular the distinction between de facto and de jure interpretations of the concept-allows the concept to explain when and why a placebo control may be necessary to answer a question of clinical importance.
当已经存在经证实有效的治疗方法时,临床 equipoise 的概念限制了安慰剂对照在临床试验中的使用。临床 equipoise 的几位批评者针对这一限制提出了所谓的反例——描述了一些伦理上的安慰剂对照试验案例,这些案例显然违反了临床 equipoise。在本文中,我们对这些例子做出回应,并表明临床 equipoise 对安慰剂的限制并不像这些作者所认为的那样严格。我们认为,对临床 equipoise 进行更细致入微的理解——尤其是对该概念的实际和法律解释之间的区别——能够使该概念解释何时以及为何需要安慰剂对照来回答具有临床重要性的问题。