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在埃博拉病毒病疫情期间进行临床治疗试验的监管和操作复杂性。

Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic.

机构信息

Epidemic Diseases Research Group Oxford (ERGO), Centre for Tropical Medicine and Global Health, University of Oxford, United Kingdom.

International Severe Acute Respiratory and Emerging Infection Consortium, Nuffield Department of Medicine, University of Oxford, United Kingdom.

出版信息

Clin Infect Dis. 2018 Apr 17;66(9):1454-1457. doi: 10.1093/cid/cix1061.

DOI:10.1093/cid/cix1061
PMID:29206908
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5905621/
Abstract

The first phase II and III clinical trials for Ebola virus disease treatments were conducted during the West Africa outbreak. We report the operational practicalities of conducting a phase II clinical trial of TKM-130803 to international standards during this outbreak.

摘要

在西非疫情期间进行了埃博拉病毒病治疗的首次 II 期和 III 期临床试验。我们报告了在此次疫情期间按照国际标准进行 TKM-130803 二期临床试验的操作实践情况。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/715f/5905621/fbf0a08d52cf/cix106101.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/715f/5905621/fbf0a08d52cf/cix106101.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/715f/5905621/fbf0a08d52cf/cix106101.jpg

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