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作者信息

Caplan Arthur L, Plunkett Carolyn, Levin Bruce

机构信息

a New York University Langone Medical Center.

出版信息

Am J Bioeth. 2015;15(4):4-10. doi: 10.1080/15265161.2015.1010993.

Abstract

There are competing ethical concerns when it comes to designing any clinical research study. Clinical trials of possible treatments for Ebola virus are no exception. If anything, the competing ethical concerns are exacerbated in trying to find answers to a deadly, rapidly spreading, infectious disease. The primary goal of current research is to identify experimental therapies that can cure Ebola or cure it with reasonable probability in infected individuals. Pursuit of that goal must be methodologically sound, practical and consistent with prevailing norms governing human subjects research. Some maintain that only randomized controlled trials (RCTs) with a placebo or standard-of-care arm can meet these conditions. We maintain that there are alternative trial designs that can do so as well and that sometimes these are preferable to RCTs.

摘要

在设计任何临床研究时,都存在相互冲突的伦理考量。埃博拉病毒可能治疗方法的临床试验也不例外。如果说有什么不同的话,那就是在试图找到一种致命、迅速传播的传染病的答案时,相互冲突的伦理考量会更加突出。当前研究的主要目标是确定能够治愈埃博拉或在感染个体中以合理概率治愈它的实验性疗法。追求这一目标必须在方法上合理、切实可行,并符合现行的人类受试者研究规范。一些人认为,只有设有安慰剂或标准治疗组的随机对照试验(RCT)才能满足这些条件。我们认为,也有其他可以做到这一点的试验设计,而且有时这些设计比随机对照试验更可取。

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本文引用的文献

1
Evaluating Ebola therapies--the case for RCTs.评估埃博拉治疗方法——随机对照试验的必要性
N Engl J Med. 2014 Dec 18;371(25):2350-1. doi: 10.1056/NEJMp1414145. Epub 2014 Dec 3.
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Randomised controlled trials for Ebola: practical and ethical issues.埃博拉病毒的随机对照试验:实践与伦理问题
Lancet. 2014 Oct 18;384(9952):1423-4. doi: 10.1016/S0140-6736(14)61734-7. Epub 2014 Oct 13.
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Ethical considerations of experimental interventions in the Ebola outbreak.埃博拉疫情中实验性干预措施的伦理考量
Lancet. 2014 Nov 22;384(9957):1896-1899. doi: 10.1016/S0140-6736(14)61315-5. Epub 2014 Aug 22.
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Subversive subjects: rule-breaking and deception in clinical trials.颠覆性受试者:临床试验中的违规与欺骗行为
J Law Med Ethics. 2013 Winter;41(4):829-40, Table of Contents. doi: 10.1111/jlme.12093.

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