Caplan Arthur L, Plunkett Carolyn, Levin Bruce
a New York University Langone Medical Center.
Am J Bioeth. 2015;15(4):4-10. doi: 10.1080/15265161.2015.1010993.
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.
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。
