The ethics of using placebo in randomised controlled trials: a case study of a Plasmodium vivax antirelapse trial.
The ethics of using placebo in randomised controlled trials: a case study of a Plasmodium vivax antirelapse trial.
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DOI：
10.1186/s12910-018-0259-4
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发表时间：
2018-03-06
影响因子：
2.7
通讯作者：
Price RN
中科院分区：
文献类型：
--
作者：
Cheah PY;Steinkamp N;von Seidlein L;Price RN
在随机对照试验中使用安慰剂是一个相当大的伦理辩论的主题。在本文中，我们提出了一套考虑因素，以评估安慰剂对照试验的伦理学，包括：研究的社会价值;需要一个随机对照试验和安慰剂;护理标准;风险的伤害，由于管理的安慰剂和损害利益的平衡;临床平衡;和双重标准。我们使用一个正在进行的大型多中心、安慰剂对照、双盲、随机试验的病例研究来说明这些考虑因素的应用，以确定伯氨喹抗间日疟复发的疗效。迫切需要伯氨喹抗复发研究，以合理化管理一种潜在的致命疾病。提供了使用安慰剂组的伦理理由，理由是大多数流行地区目前实际应用的护理标准不包括伯氨喹。也有人认为伯氨喹研究组之间存在临床平衡，安慰剂组的危害风险就是复发风险，这只不过是不包括在试验中，没有双重标准。基于我们的一系列考虑，我们得出结论，安慰剂组在本研究中不仅是合理的，而且是必要的。我们建议，类似的考虑应前瞻性地应用于其他安慰剂对照试验和观察对照组，其中没有提供治疗。
The use of placebos in randomised controlled trials is a subject of considerable ethical debate. In this paper we present a set of considerations to evaluate the ethics of placebo controlled trials that includes: social value of the study; need for a randomised controlled trial and placebo; standards of care; risks of harm due to administration of placebo and the harm benefit balance; clinical equipoise; and double standards. We illustrate the application of these considerations using a case study of a large ongoing multicentre, placebo-controlled, double-blinded, randomised trial to determine primaquine anti-relapse efficacy in vivax malaria. There is an urgent need for primaquine anti-relapse studies in order to rationalise the management of a potentially fatal disease. An ethical justification for the use of the placebo arm is provided on the grounds that the actual current applied standard of care in most endemic places does not include primaquine. It has also been argued that there is clinical equipoise among the primaquine study arms and that the risk of harms of being in the placebo arm is the risk of having relapse, which is no more than not being included in the trial, and that there are no double standards. Based on our set of considerations, we conclude that a placebo arm is not only justified but imperative in this study. We propose that similar considerations should be prospectively applied to other placebo controlled trials and observational control arms where no treatment is offered.
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影响因子：
3
作者：
White NJ
通讯作者：
White NJ
影响因子：
3
作者：
John GK;Douglas NM;von Seidlein L;Nosten F;Baird JK;White NJ;Price RN
通讯作者：
Price RN
影响因子：
3
作者：
Ley B;Luter N;Espino FE;Devine A;Kalnoky M;Lubell Y;Thriemer K;Baird JK;Poirot E;Conan N;Kheong CC;Dysoley L;Khan WA;Dion-Berboso AG;Bancone G;Hwang J;Kumar R;Price RN;von Seidlein L;Domingo GJ
通讯作者：
Domingo GJ
影响因子：
3.3
作者：
Miller, FG;Brody, H
通讯作者：
Brody, H
影响因子：
1.3
作者：
COATNEY, GR
通讯作者：
COATNEY, GR