Resources

Organizing the donation of convalescent plasma for a therapeutic clinical trial on Ebola Virus Disease: The experience in Guinea

This resource reports on the successful organization of donor mobilization and plasma collection as part of the Ebola-Tx clinical trial from November 2014 to July 2015 in Conakry, Guinea, the challenges they faced, and efforts made to address these.

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

This resource describes the main challenges of the implementation of a trial in the Ebola treatment center of Guéckédou. Following the principles of the Good Clinical Research Practices, it reports 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.

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'He is now like a brother, I can even give him some blood': Relational ethics and material exchanges in a malaria vaccine 'trial community' in The Gambia

This paper explores social relations within the ‘trial community’ (staff and volunteers) of a Malaria Vaccine Trial (MVT), implemented by the Medical Research Council (MRC) in The Gambia between 2001 and 2004. It situates ethical concerns with medical research within the everyday life of scientific fieldwork. Based upon discussions with volunteers and staff, it looks at processes of mediation between scientific project and study population, between formal ethics, local ethical debates, and everyday practice.

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EBOVAC-Salone: Lessons learned from implementing an Ebola vaccine trial in an Ebola-affected country

This article describes the experiences of the EBOVAC-Salone research team in setting up and implementing the trial, and provides recommendations for research teams aiming to conduct clinical trials in future outbreak situations.

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When experiments travel: Clinical trials and the global search for human subjects

This book aims to challenge conventional understandings of the ethics and politics of transnational science and change the way we think about global medicine and the new infrastructures of our lives. It explores the clinical trials industry through both an economic and cultural lens to examine the ways commercial medical science is currently being integrated into local health systems.

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WHO: Efficacy trials of Lassa therapeutics: endpoints, trial design, site selection

This resource is a final report of a WHO workshop regarding efficacy trials of Lassa therapeutics. 

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WHO: Target product profile for Lassa virus vaccine

This resource is an outline of the WHO target product profile development  for Lassa, as well as a generic description of WHO's Vaccine Pre-qualification process.

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