Abstract
Author summaryDuring 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.
Highlights
The largest and most complex Ebola virus outbreak in history started in Guinea in December 2013 and spread rapidly to neighboring countries in March 2014 [1]
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
Summary
The largest and most complex Ebola virus outbreak in history started in Guinea in December 2013 and spread rapidly to neighboring countries in March 2014 [1]. In August 2014, the World Health Organization (WHO) convened an advisory panel that unanimously concluded it would be acceptable to assess potential unregistered interventions that had shown promising results in preclinical laboratory and animal phases but had not been fully evaluated in phase I or II trials in humans [3]. June 22, 2017 was extensively involved in frontline care for Ebola patients, the French National Research Institute for Health and Medical Research (INSERM), and Guinean authorities created a partnership to conduct a “proof of concept” study on the efficacy of high-dose favipiravir in reducing mortality in patients with EVD. Favipiravir, a novel viral RNA polymerase inhibitor developed by the Japanese company Toyama/Fujifilm, was a prioritized drug on the WHO expert panel’s list because of its good human safety data and promising results against the Ebola virus in preclinical studies [4,5,6,7,8]. The protocol of the trial has been described elsewhere [9]
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