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临床试验中的伦理与统计方法

Ethics and statistical methodology in clinical trials.

作者信息

Palmer C R

机构信息

University of Cambridge.

出版信息

J Med Ethics. 1993 Dec;19(4):219-22. doi: 10.1136/jme.19.4.219.

DOI:10.1136/jme.19.4.219
PMID:8308877
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1376342/
Abstract

Statisticians in medicine can disagree on appropriate methodology applicable to the design and analysis of clinical trials. So called Bayesians and frequentists both claim ethical superiority. This paper, by defining and then linking together various dichotomies, argues there is a place for both statistical camps. The choice between them depends on the phase of clinical trial, disease prevalence and severity, but supremely on the ethics underlying the particular trial. There is always a tension present between physicians primarily obligated to their own patients (the weight of 'individual ethics') and ethical committees responsible for the scientific merit of the trial and its long-term implications ('collective ethics'). Individual ethics, it is proposed, favour the Bayesian approach; collective ethics, the frequentist. Though in some situations the choice appears clear-cut, there remain other where both methodologies can be appropriate.

摘要

医学领域的统计学家对于适用于临床试验设计和分析的适当方法可能存在分歧。所谓的贝叶斯派和频率派都声称自己在伦理上更具优势。本文通过定义并将各种二分法联系起来,认为两个统计学阵营都有其存在的空间。在它们之间做出选择取决于临床试验的阶段、疾病的患病率和严重程度,但最重要的是取决于特定试验背后的伦理观念。主要对自己的患者负责的医生(“个体伦理”的分量)与负责试验的科学价值及其长期影响的伦理委员会(“集体伦理”)之间始终存在紧张关系。有人提出,个体伦理倾向于贝叶斯方法;集体伦理则倾向于频率派。尽管在某些情况下选择似乎很明确,但仍有其他情况两种方法都可能适用。

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Contemp Clin Trials. 2011 Jul;32(4):561-8. doi: 10.1016/j.cct.2011.03.010. Epub 2011 Mar 29.
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Informed consent and research design in critical care medicine.重症医学中的知情同意与研究设计。
Crit Care. 1999;3(3):R29-R33. doi: 10.1186/cc347.

本文引用的文献

1
At what level of collective equipoise does a clinical trial become ethical?临床试验在何种集体均衡水平下才具有伦理合理性?
J Med Ethics. 1991 Mar;17(1):30-4. doi: 10.1136/jme.17.1.30.