title: Beating the Odds: Successful Establishment of a Phase II/III Clinical Research Trial in Resource-Poor Liberia during the Largest-Ever Ebola Outbreak.
abstract: It has been argued that a country such as Liberia, not fully recovered from the devastation of decades of civil unrest, lacked the appropriate ethical and regulatory framework, basic human and health care services, and infrastructure to carry out clinical trials according to international standards of quality during a public health emergency. However, as Liberia, Sierra Leone, and Guinea were being ravaged by the largest and most devastating Ebola Virus Disease (EVD) outbreak ever recorded, the topic of conducting clinical trials of experimental vaccine and treatment candidates in these resource-poor countries generated the keen interest and concern of scientists, researchers, physicians, bioethicists, philanthropists, and even politicians. Decisive action on behalf of the Liberian government, and a timely positive and supportive response from the United States (U.S.) government, led to the formation of PREVAIL (Partnership for Research on Ebola Vaccines in Liberia) - a clinical research partnership between the two governments. Within a span of 12 weeks, this partnership accomplished the unimaginable: the successful initiation of a Phase II/III vaccine clinical trial for EVD in Liberia. This paper will discuss the dynamics of the research collaboration, barriers encountered, breakthroughs realized, key elements of success, and lessons learned in the process.
authors.affiliation: Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc., NCI Campus at Frederick, Frederick, MD, 21702, USA.
authors.forename: J
authors.initials: J
authors.lastname: Doe-Anderson
authors.affiliation: Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc., NCI Campus at Frederick, Frederick, MD, 21702, USA.
authors.forename: B
authors.initials: B
authors.lastname: Baseler
authors.affiliation: Intramural Clinical Management and Operations Branch, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
authors.forename: P
authors.initials: P
authors.lastname: Driscoll
authors.affiliation: The Mitchell Group, Monrovia, Liberia.
authors.forename: M
authors.initials: M
authors.lastname: Johnson
authors.affiliation: The Mitchell Group, Monrovia, Liberia.
authors.forename: J
authors.initials: J
authors.lastname: Lysander
authors.affiliation: Office of Strategic Planning and Assessment, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
authors.forename: L
authors.initials: L
authors.lastname: McNay
authors.affiliation: Clinical Research Directorate/Clinical Monitoring Research Program, Leidos Biomedical Research, Inc., NCI Campus at Frederick, Frederick, MD, 21702, USA.
authors.forename: W S
authors.initials: WS
authors.lastname: Njoh
authors.affiliation: Office of Strategic Planning and Assessment, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
authors.forename: M
authors.initials: M
authors.lastname: Smolskis
authors.affiliation: Nursing Department, National Institutes of Health Clinical Center, Bethesda, MD USA.
authors.forename: L
authors.initials: L
authors.lastname: Wehrlen
authors.affiliation: Office of Strategic Planning and Assessment, National Institute of Allergy and Infectious Diseases, Rockville, MD, USA.
authors.forename: J
authors.initials: J
authors.lastname: Zuckerman
keywords: Ebola; Ebola virus disease; building capacity; global clinical research partnerships; international clinical research; international partnerships; vaccine clinical trials