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临床试验在何种集体均衡水平下才具有伦理合理性?

At what level of collective equipoise does a clinical trial become ethical?

作者信息

Johnson N, Lilford R J, Brazier W

机构信息

Department of Obstetrics and Gynaecology, St James's University Hospital.

出版信息

J Med Ethics. 1991 Mar;17(1):30-4. doi: 10.1136/jme.17.1.30.

Abstract

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.

摘要

人们常常认为,如果临床医生无法决定提供两种治疗方法中的哪一种,进行试验可能是符合伦理的,但如果她/他有偏好,那就是不符合伦理的。由于个体临床医生通常有偏好,按照这种论点,大多数试验可能会被判定为不符合伦理。《新英格兰医学杂志》最近的一篇重要文章认为,个体偏好不如知情临床医生的集体不确定性重要。如果临床医生意见平分秋色,就存在一种集体平衡状态,试验就是符合伦理的。然而,临床医生很少会完全平分秋色。我们进行了一项伦理测量研究,以了解在试验中的潜在受试者认为试验不符合伦理之前,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,我们一半的受试者认为试验不符合伦理。换句话说,当70%的专家支持一种治疗方法时,50%的受试者会希望采用那种治疗方法而不是进行严格评估。当平衡被打破超过80:20时,不到3%的受试者会认为人体试验在道德上是合理的。

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