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

Sara Carazo Perez, Elin Folkesson, Xavier Anglaret, Abdoul-Habib Beavogui, Emmanuel Berbain, Alseny-Modet Camara, Evelyn Depoortere, Annabelle Lefevre, Piet Maes, Kristian Nodtvedt Malme, Jean-Marie Denis Malvy, Sien Ombelet, Geertrui Poelaert, Daouda Sissoko, Alexis Tounkara, Pierre Trbovic, Pascal Piguet, Annick Antierens

Research output: Contribution to journalA1: Web of Science-article

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 Gueckedou. 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.

Original languageEnglish
Article number0005545
JournalPLoS Neglected Tropical Diseases
Volume11
Issue number6
Number of pages9
ISSN1935-2735
DOIs
Publication statusPublished - 2017

Keywords

  • VIRUS-DISEASE
  • FAVIPIRAVIR T-705
  • HEMORRHAGIC-FEVER
  • OUTBREAK
  • INFECTION
  • MODEL
  • THERAPIES
  • CHILDREN

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