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

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.

Detalles Bibliográficos
Autores principales: Rojek, Amanda M, Dunning, Jake, Leliogdowicz, Aleksandra, Castle, Lyndsey, Van Lieshout, Mary, Carson, Gail, Sahr, Foday, Olliaro, Piero, Horby, Peter W
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Brief Reports
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5905621/
https://www.ncbi.nlm.nih.gov/pubmed/29206908
http://dx.doi.org/10.1093/cid/cix1061
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author Rojek, Amanda M
Dunning, Jake
Leliogdowicz, Aleksandra
Castle, Lyndsey
Van Lieshout, Mary
Carson, Gail
Sahr, Foday
Olliaro, Piero
Horby, Peter W
author_facet Rojek, Amanda M
Dunning, Jake
Leliogdowicz, Aleksandra
Castle, Lyndsey
Van Lieshout, Mary
Carson, Gail
Sahr, Foday
Olliaro, Piero
Horby, Peter W
author_sort Rojek, Amanda M
collection PubMed
description 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.
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spelling pubmed-59056212018-04-21 Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic Rojek, Amanda M Dunning, Jake Leliogdowicz, Aleksandra Castle, Lyndsey Van Lieshout, Mary Carson, Gail Sahr, Foday Olliaro, Piero Horby, Peter W Clin Infect Dis Brief Reports 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. Oxford University Press 2018-05-01 2017-12-01 /pmc/articles/PMC5905621/ /pubmed/29206908 http://dx.doi.org/10.1093/cid/cix1061 Text en © The Author(s) 2017. Published by Oxford University Press for the Infectious Diseases Society of America. http://creativecommons.org/licenses/by/4.0/ 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.
spellingShingle Brief Reports
Rojek, Amanda M
Dunning, Jake
Leliogdowicz, Aleksandra
Castle, Lyndsey
Van Lieshout, Mary
Carson, Gail
Sahr, Foday
Olliaro, Piero
Horby, Peter W
Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic
title Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic
title_full Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic
title_fullStr Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic
title_full_unstemmed Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic
title_short Regulatory and Operational Complexities of Conducting a Clinical Treatment Trial During an Ebola Virus Disease Epidemic
title_sort regulatory and operational complexities of conducting a clinical treatment trial during an ebola virus disease epidemic
topic Brief Reports
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5905621/
https://www.ncbi.nlm.nih.gov/pubmed/29206908
http://dx.doi.org/10.1093/cid/cix1061
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