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Regulatory and operational complexities of conducting a clinical treatment trial during an Ebola Virus Disease epidemic
File(s)
Author(s)
Rojek, Amanda M
Dunning, Jake
Leliogdowicz, Aleksandra
Castle, Lyndsey
Van Lieshout, Mary
Type
Journal Article
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.
Date Issued
2017-12-01
Date Acceptance
2017-11-30
Citation
Clinical Infectious Diseases, 2017, 66 (9), pp.1454-1457
URI
URL
DOI
ISSN
1058-4838
Publisher
Oxford University Press (OUP)
Start Page
1454
End Page
1457
Journal / Book Title
Clinical Infectious Diseases
Volume
66
Issue
9
Copyright Statement
© The Author(s) 2017. Published by Oxford University Press for the Infectious Diseases Society of America.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
Identifier
https://academic.oup.com/cid/article/66/9/1454/4682608
Subjects
Africa, Western
Biomedical Research
Clinical Trials, Phase II as Topic
Data Collection
Disease Outbreaks
Epidemics
Hemorrhagic Fever, Ebola
Humans
Informed Consent
Monitoring, Physiologic
RNA, Small Interfering
Research Design
Sierra Leone
Humans
Hemorrhagic Fever, Ebola
RNA, Small Interfering
Monitoring, Physiologic
Data Collection
Disease Outbreaks
Biomedical Research
Research Design
Informed Consent
Africa, Western
Sierra Leone
Clinical Trials, Phase II as Topic
Epidemics
06 Biological Sciences
11 Medical and Health Sciences
Microbiology
Publication Status
Published
Date Publish Online
2017-12-01