Challenges in Preparing and Implementing a Clinical Trial at Field Level in an Ebola Emergency: A Case Study in Guinea, West Africa

Hdl Handle:
http://hdl.handle.net/10144/618954
Title:
Challenges in Preparing and Implementing a Clinical Trial at Field Level in an Ebola Emergency: A Case Study in Guinea, West Africa
Authors:
Carazo Perez, S; Folkesson, E; Anglaret, X; Beavogui, A; Berbain, E; Camara, A; Depoortere, E; Lefevre, A; Maes, P; Malme, K; Malvy, J; Ombelet, S; Poelaert, G; Sissoko, D; Tounkara, A; Trbovic, P; Piguet, P; Antierens, A
Journal:
PLoS Neglected Tropical Diseases
Abstract:
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.
Publisher:
Public Library of Science
Issue Date:
22-Jun-2017
URI:
http://hdl.handle.net/10144/618954
DOI:
10.1371/journal.pntd.0005545
PubMed ID:
28640812
Submitted date:
2017-06-26
Language:
en
ISSN:
1935-2735
Appears in Collections:
Other Diseases

Full metadata record

DC FieldValue Language
dc.contributor.authorCarazo Perez, Sen
dc.contributor.authorFolkesson, Een
dc.contributor.authorAnglaret, Xen
dc.contributor.authorBeavogui, Aen
dc.contributor.authorBerbain, Een
dc.contributor.authorCamara, Aen
dc.contributor.authorDepoortere, Een
dc.contributor.authorLefevre, Aen
dc.contributor.authorMaes, Pen
dc.contributor.authorMalme, Ken
dc.contributor.authorMalvy, Jen
dc.contributor.authorOmbelet, Sen
dc.contributor.authorPoelaert, Gen
dc.contributor.authorSissoko, Den
dc.contributor.authorTounkara, Aen
dc.contributor.authorTrbovic, Pen
dc.contributor.authorPiguet, Pen
dc.contributor.authorAntierens, Aen
dc.date.accessioned2017-07-05T18:28:47Z-
dc.date.available2017-07-05T18:28:47Z-
dc.date.issued2017-06-22-
dc.date.submitted2017-06-26-
dc.identifier.citationChallenges in Preparing and Implementing a Clinical Trial at Field Level in an Ebola Emergency: A Case Study in Guinea, West Africa. 2017, 11 (6):e0005545 PLoS Negl Trop Disen
dc.identifier.issn1935-2735-
dc.identifier.pmid28640812-
dc.identifier.doi10.1371/journal.pntd.0005545-
dc.identifier.urihttp://hdl.handle.net/10144/618954-
dc.description.abstractDuring 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.en
dc.language.isoenen
dc.publisherPublic Library of Scienceen
dc.rightsArchived with thanks to PLoS Neglected Tropical Diseasesen
dc.titleChallenges in Preparing and Implementing a Clinical Trial at Field Level in an Ebola Emergency: A Case Study in Guinea, West Africaen
dc.identifier.journalPLoS Neglected Tropical Diseasesen

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