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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Bibliographic Details
Published in:	PLoS neglected tropical diseases Vol. 11; no. 6; p. e0005545
Main Authors:	Carazo Perez, Sara, Folkesson, Elin, Anglaret, Xavier, Beavogui, Abdoul-Habib, Berbain, Emmanuel, Camara, Alseny-Modet, Depoortere, Evelyn, Lefevre, Annabelle, Maes, Piet, Malme, Kristian Nødtvedt, Malvy, Jean-Marie Denis, Ombelet, Sien, Poelaert, Geertrui, Sissoko, Daouda, Tounkara, Alexis, Trbovic, Pierre, Piguet, Pascal, Antierens, Annick
Format:	Journal Article
Language:	English
Published:	United States Public Library of Science 22-06-2017 Public Library of Science (PLoS)
Subjects:	Amides - therapeutic use Antiviral agents Antiviral Agents - therapeutic use Biology and life sciences Care and treatment Case studies Clinical trials Clinical Trials as Topic - organization & administration Clinical Trials as Topic - standards Collaboration Communication Confidentiality Disease Outbreaks Drug therapy Drugs Ebola hemorrhagic fever Ebola virus Ebolavirus Emergencies Emergency medical services Epidemics Ethics Guinea - epidemiology Hemorrhagic Fever, Ebola - drug therapy Hemorrhagic Fever, Ebola - epidemiology Hospitals Humanitarian aid Humans Informed Consent Medical Records - standards Medical research Medicine and Health Sciences Organizations Outbreaks Patients People and Places Protocols Pyrazines - therapeutic use Pyridazine Research and Analysis Methods Research Design Risk assessment RNA polymerase Social Sciences Testing Therapeutic applications Tropical diseases Viewpoints Viral diseases Viruses Guinea Belgium France West Africa
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Summary:	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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 The authors have declared that no competing interests exist.
ISSN:	1935-2735 1935-2727 1935-2735
DOI:	10.1371/journal.pntd.0005545