TY - JOUR
T1 - Challenges in preparing and implementing a clinical trial at field level in an Ebola emergency: a case study in Guinea, West Africa
AU - Perez, Sara Carazo
AU - Folkesson, Elin
AU - Anglaret, Xavier
AU - Beavogui, Abdoul-Habib
AU - Berbain, Emmanuel
AU - Camara, Alseny-Modet
AU - Depoortere, Evelyn
AU - Lefevre, Annabelle
AU - Maes, Piet
AU - Malme, Kristian Nodtvedt
AU - Malvy, Jean-Marie Denis
AU - Ombelet, Sien
AU - Poelaert, Geertrui
AU - Sissoko, Daouda
AU - Tounkara, Alexis
AU - Trbovic, Pierre
AU - Piguet, Pascal
AU - Antierens, Annick
N1 - FTX; DOAJ
PY - 2017
Y1 - 2017
N2 - 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.
AB - 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.
KW - VIRUS-DISEASE
KW - FAVIPIRAVIR T-705
KW - HEMORRHAGIC-FEVER
KW - OUTBREAK
KW - INFECTION
KW - MODEL
KW - THERAPIES
KW - CHILDREN
U2 - 10.1371/journal.pntd.0005545
DO - 10.1371/journal.pntd.0005545
M3 - A1: Web of Science-article
SN - 1935-2735
VL - 11
JO - PLoS Neglected Tropical Diseases
JF - PLoS Neglected Tropical Diseases
IS - 6
M1 - 0005545
ER -