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.

Addressing challenges for clinical research responses to emerging epidemics and pandemics: a scoping review

“…A cross-cutting theme identified was the need to strengthen collaboration and coordination between organisations involved in outbreak response at all levels [3,7,81]. Effective partnerships between countries and international organisations, such as public health, clinical research organisations, non-governmental organisations (NGOs), pharmaceutical companies and regulatory agencies, were described as instrumental for success [3,14,16,19]. International research collaborations should be tied to capacity building and be genuinely collaborative [22], with local stakeholders engaged from inception [1, 3, 13, 16-19, 22, 26, 29, 31, 32, 36, 38, 40, 44, 50, 51].…”

‘We will soon be dead’: stigma and cascades of looping effects in a collaborative Ebola vaccine trial

“…As part of collaboration between the US and Liberian governments, more than 100 Liberians were employed to establish culturally sensitive communications, advocacy and community engagement, deemed essential to the protection of human subjects. Official reports about the trial (Doe-Anderson et al, 2016;Kennedy et al, 2016) provide thick description of the collaborative component, including changes to participant recruitment and other adjustments that research teams made. Doe-Anderson and colleagues note that stigma remained a challenge:…”

“…There was still a degree of stigma and discrimination associated with participation in the vaccine trial, as some members of the community believed that participants were being vaccinated with the Ebola virus and would eventually infect others in the community (Doe-Anderson et al, 2016). At that time when Ebola research was launched in Liberia, numerous rumours were proliferating that Ebola was not real, that Ebola was a man-made disease designed to kill Africans, that the government had created the Ebola scheme to attract international funding. President Ellen Johnson Sirleaf was identified with the Queen of Shebaa reincarnated woman from the netherworld thirsty for blood to boost her powers (Epstein, 2015;Perry & Sayndee, 2016).…”

“…Collaborative partnerships also involved close work with traditional leaders and artists, some of whom created and promoted songs about collaboration with Ebola research. As a result, the trial was able to beat the odds and rapidly recruit 1500 people with 98% compliance rates (Doe-Anderson et al, 2016;Kennedy et al, 2016).…”

Conventional Wisdom versus Actual Outcomes: Challenges in the Conduct of an Ebola Vaccine Trial in Liberia during the International Public Health Emergency

“…Unanimity was not always reached, and consensus building was relied on when speedy decisions were imperative. The Liberian and U.S. technical team began trial planning in early November, and the trial opened in less than 3 months, a remarkable achievement given the usual expectation of 1–3 years for randomized clinical trials 12 , 13 …”