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

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.

Clinical trials during the COVID-19 pandemic: Challenges of putting scientific and ethical principles into practice

“…who conducted the clinical Ebola trial recommend that individual patient's interests must prevail over reliability of trial methodology when the patients face a high risk of death. [ 7 ] In a pandemic scenario, high number of serious patients presenting simultaneously and high mortality rate make random allocation of patients from within the same family or location to receive or not receive an experimental drug, ethically unacceptable. [ 4 ] Furthermore, critically ill patients would find randomization procedure difficult to understand.…”

“…However, in a condition such as Ebola, which has high mortality in children under 5 years, excluding children would compromise trial acceptance. [ 4 7 ] As dose-finding or tolerability data in children were not available for favipiravir, the children were given weight-based doses based on the adult dosage in clinical trial of favipiravir in Ebola, for which safety data were available. Although pregnant women suffering from Ebola had a higher case-fatality rate compared to nonpregnant women, the pregnant women were excluded from this trial due to the potential risk of embryonic teratogenicity and lack of insurance.…”

“…Although pregnant women suffering from Ebola had a higher case-fatality rate compared to nonpregnant women, the pregnant women were excluded from this trial due to the potential risk of embryonic teratogenicity and lack of insurance. [ 7 ]…”

The Plasma Mobile, ‘A gift from heaven’: The impact of health technology transfer on trial perceptions and expectations during the Ebola-Tx Trial, Conakry

“…One of the clinical trials that took place in the same period of time as Ebola-Tx in Guinea, was the 'Jiki trial'. Jiki means 'hope' in Mandingo language [59]. This hope was not an exclusive experience and motivation for EVD patients' achievements of survival.…”

Catching Chances: The Movement to Be on the Ground and Research Ready before an Outbreak

“…MSF has managed its own ethics review board since 2002, and maintains a broad research portfolio [ 31 , 32 ]. In the Ebola epidemic, MSF research activity centered upon a cooperation fielding favipiravir [ 6 , 7 , 33 , 34 ]. IMC, similarly, has developed organic research programming [ 35 ].…”