期刊
AMERICAN JOURNAL OF BIOETHICS
卷 15, 期 4, 页码 4-10出版社
ROUTLEDGE JOURNALS, TAYLOR & FRANCIS LTD
DOI: 10.1080/15265161.2015.1010993
关键词
Ebola treatment trials; compassionate access; adaptive trial design; international research; expanded access; research ethics; placebo controls; selection trials; randomized controlled trials (RCT); cluster randomized designs; sequential designs; standard of care controls; elimination of inferior treatments
资金
- NIMH NIH HHS [P30 MH043520] Funding Source: Medline
- NINDS NIH HHS [R13 NS065622] Funding Source: Medline
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.
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