Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.

During the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of th...

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Main Authors: Sara Carazo Perez, Elin Folkesson, Xavier Anglaret, Abdoul-Habib Beavogui, Emmanuel Berbain, Alseny-Modet Camara, Evelyn Depoortere, Annabelle Lefevre, Piet Maes, Kristian Nødtvedt Malme, Jean-Marie Denis Malvy, Sien Ombelet, Geertrui Poelaert, Daouda Sissoko, Alexis Tounkara, Pierre Trbovic, Pascal Piguet, Annick Antierens
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2017-06-01
Series:PLoS Neglected Tropical Diseases
Online Access:http://europepmc.org/articles/PMC5480829?pdf=render
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author Sara Carazo Perez
Elin Folkesson
Xavier Anglaret
Abdoul-Habib Beavogui
Emmanuel Berbain
Alseny-Modet Camara
Evelyn Depoortere
Annabelle Lefevre
Piet Maes
Kristian Nødtvedt Malme
Jean-Marie Denis Malvy
Sien Ombelet
Geertrui Poelaert
Daouda Sissoko
Alexis Tounkara
Pierre Trbovic
Pascal Piguet
Annick Antierens
author_facet Sara Carazo Perez
Elin Folkesson
Xavier Anglaret
Abdoul-Habib Beavogui
Emmanuel Berbain
Alseny-Modet Camara
Evelyn Depoortere
Annabelle Lefevre
Piet Maes
Kristian Nødtvedt Malme
Jean-Marie Denis Malvy
Sien Ombelet
Geertrui Poelaert
Daouda Sissoko
Alexis Tounkara
Pierre Trbovic
Pascal Piguet
Annick Antierens
author_sort Sara Carazo Perez
collection DOAJ
description During the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of the implementation of the trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, we explored the aspects of the community's communication and engagement, ethical conduct, trial protocol compliance, informed consent of participants, ongoing benefit/risk assessment, record keeping, confidentiality of patients and study data, and roles and responsibilities of the actors involved. We concluded that several challenges have to be addressed to successfully implement a clinical trial during an international medical emergency but that the potential for collaboration between research teams and humanitarian organizations needs to be highlighted.
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spelling doaj.art-8659f2940e00436fbf87257cca6c140e2022-12-21T22:32:38ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352017-06-01116e000554510.1371/journal.pntd.0005545Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.Sara Carazo PerezElin FolkessonXavier AnglaretAbdoul-Habib BeavoguiEmmanuel BerbainAlseny-Modet CamaraEvelyn DepoortereAnnabelle LefevrePiet MaesKristian Nødtvedt MalmeJean-Marie Denis MalvySien OmbeletGeertrui PoelaertDaouda SissokoAlexis TounkaraPierre TrbovicPascal PiguetAnnick AntierensDuring the large Ebola outbreak that affected West Africa in 2014 and 2015, studies were launched to evaluate potential treatments for the disease. A clinical trial to evaluate the effectiveness of the antiviral drug favipiravir was conducted in Guinea. This paper describes the main challenges of the implementation of the trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, we explored the aspects of the community's communication and engagement, ethical conduct, trial protocol compliance, informed consent of participants, ongoing benefit/risk assessment, record keeping, confidentiality of patients and study data, and roles and responsibilities of the actors involved. We concluded that several challenges have to be addressed to successfully implement a clinical trial during an international medical emergency but that the potential for collaboration between research teams and humanitarian organizations needs to be highlighted.http://europepmc.org/articles/PMC5480829?pdf=render
spellingShingle Sara Carazo Perez
Elin Folkesson
Xavier Anglaret
Abdoul-Habib Beavogui
Emmanuel Berbain
Alseny-Modet Camara
Evelyn Depoortere
Annabelle Lefevre
Piet Maes
Kristian Nødtvedt Malme
Jean-Marie Denis Malvy
Sien Ombelet
Geertrui Poelaert
Daouda Sissoko
Alexis Tounkara
Pierre Trbovic
Pascal Piguet
Annick Antierens
Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.
PLoS Neglected Tropical Diseases
title Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.
title_full Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.
title_fullStr Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.
title_full_unstemmed Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.
title_short Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: A case study in Guinea, West Africa.
title_sort challenges in preparing and implementing a clinical trial at field level in an ebola emergency a case study in guinea west africa
url http://europepmc.org/articles/PMC5480829?pdf=render
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