Arranging good clinical practices training and trial monitoring for a vaccine efficacy study during a public health emergency of international concern.

ABSTRACT

The 2014-2015 outbreak of Ebola Virus Disease (EVD) in West Africa was unprecedented in size and scope. The World Health Organization, government of Guinea and other partners undertook a field trial of efficacy of an Ebola vaccine in Guinea, with a parallel immunogenicity study in front-line workers. However, several obstacles had to be overcome. One was the need to teach Good Clinical Practices to a large group of field workers who had never participated in vaccine clinical trial research. Because the trial design was complex, performing this efficacy trial during an Ebola outbreak would have been challenging even for experienced investigators. For field workers who had never previously participated in a clinical trial, this constituted a daunting challenge. Another challenge was to provide independent monitoring to document the quality and validity of the field trial data to support future regulatory agency licensure. Here we discuss how these challenges were overcome, and what lessons can be drawn for the future. Intensive GCP was expeditiously arranged for 251 clinical study staff on-site in Guinea. The trials were initiated within days after completion of training. Monitoring (100% of participants in the efficacy trial and 50% in the immunogenicity trial) began at the onset of the trials. Early monitoring detected many minor errors but prompt feedback and guidance from the monitors, who explained the mistakes and proposed corrective actions, diminished error frequency as the trials progressed. Monitoring later in the trials showed what one would expect in a study conducted by experienced investigators. Should a vaccine field trial have to be hastily arranged during a future emerging disease outbreak in a developing country setting, our methods of training and monitoring could provide a model.