Department of Bioethics, Clinical Center, National Institutes of Health, Building 10, Room 1C118, Bethesda, MD 20892-1156, USA.
Am J Med Sci. 2011 Oct;342(4):276-81. doi: 10.1097/MAJ.0b013e318227e871.
Equipoise is widely endorsed as a necessary requirement for ethical design and conduct of randomized controlled trials. Nevertheless, I argue in this article that the equipoise principle suffers from fundamental defects. In particular, equipoise provides flawed ethical guidance for placebo-controlled trials and for decisions to terminate trials early based on interim data relating to benefit. The problems with equipoise are traced to a "therapeutic orientation to clinical trials," which conflates the ethics of clinical research with the ethics of medical care. Because of this mistaken therapeutic orientation, equipoise fails to adequately account for the central purpose of randomized trials in providing evidence sufficient to guide health policy decisions relating to licensing new treatments and insurance coverage. I conclude that it is time to dispense with equipoise. The principles of research ethics are sufficient to provide adequate guidance to protect subjects and to promote socially valuable research without any appeal to equipoise.
均衡被广泛认为是进行随机对照试验的伦理设计和实施的必要要求。然而，我在本文中认为，均衡原则存在根本性缺陷。特别是，均衡原则为安慰剂对照试验和基于中期数据获益而提前终止试验的决策提供了有缺陷的伦理指导。均衡原则的问题可以追溯到“临床试验的治疗方向”，它将临床研究的伦理与医疗保健的伦理混为一谈。由于这种错误的治疗方向，均衡原则没有充分考虑随机试验的核心目的，即提供足够的证据来指导与许可新治疗方法和保险覆盖范围有关的卫生政策决策。我得出的结论是，是时候摒弃均衡原则了。研究伦理原则足以提供充分的指导，以保护受试者并促进具有社会价值的研究，而无需诉诸均衡原则。
