AT WHAT LEVEL OF COLLECTIVE EQUIPOISE DOES A CLINICAL-TRIAL BECOME ETHICAL
AT WHAT LEVEL OF COLLECTIVE EQUIPOISE DOES A CLINICAL-TRIAL BECOME ETHICAL
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DOI：
10.1136/jme.17.1.30
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发表时间：
1991-03-01
影响因子：
4.1
通讯作者：
BRAZIER, W
中科院分区：
文献类型：
--
作者：
JOHNSON, N;LILFORD, RJ;BRAZIER, W
经常有人认为，如果临床医生不能决定提供两种治疗方法中的哪一种，那么试验可能是道德的，但如果她/他有偏好，则是不道德的。 由于临床医生通常有自己的偏好，因此大多数试验都可以根据这一论点被判定为不道德的。 《新英格兰医学杂志》最近的一篇重要文章认为，个人偏好不如知情临床医生的集体不确定性重要。 如果临床医生被平均分配，就会有一种集体平衡的状态，试验也就符合伦理。 然而，临床医生很少会完全平分。 我们进行了一项行为计量学研究，以了解在试验中的潜在受试者认为这是不道德的之前，集体平衡会受到多大程度的干扰。 当平衡被打破超过70：30时，我们的一半受试者认为试验是不道德的。 换句话说，当70%的专家赞成一种治疗时，50%的受试者宁愿接受这种治疗，而不是接受严格的评估。 当平衡被打破超过80：20时，不到3%的受试者认为人体试验在道德上是合理的。
It has often been argued that if a clinician cannot decide which of two treatments to offer, a trial may be ethical, but it is unethical if she/he has a preference. Since individual clinicians usually have a preference, most trials could be judged unethical according to this line of argument. A recent important article in the New England Journal of Medicine argued that individual preferences are not as important as the collective uncertainty of informed clinicians. If clinicians are equally divided, there is a state of collective equipoise and a trial is ethical. However, clinicians will seldom be exactly equally divided. We conducted an ethometric study to find out how much collective equipoise can be disturbed before the potential subjects in a trial think that it is unethical. Half of our subjects perceived a trial as unethical when equipoise was disturbed beyond 70:30. In other words, when 70 per cent of experts favour one treatment, 50 per cent of subjects would prefer that treatment to be administered rather than subjected to critical assessment. When equipoise is disturbed beyond 80:20, less than 3 per cent of subjects would consider human trials morally justifiable.