COVID-19 site readiness initiative: Building clinical trial capacity for vaccine efficacy trials in Latin America in response to the pandemic.
Ann Costa Clemens S., Keiko Sekine A., Tovar-Moll F., Clemens R.
According to the World Health Organization, the American region has the highest coronavirus disease-2019 (COVID-19) cases and deaths since the start of the pandemic. This humanitarian tragedy presented the possibility of generating efficacy data from COVID-19 vaccine trials. The race to develop successful vaccines imposed a high demand for trained healthcare personnel and clinical sites where large scale randomized clinical trials could be conducted. This site readiness initiative, funded by the Bill and Melinda GatesFoundation (BMGF), was carried out to rapidly build site capacity for running COVID-19 vaccine trials in Latin America. Twenty-two sites across 7 countries were selected and received funding. Site selection was based on defined feasibility criteria which deemed these sites as suitable for running vaccine efficacy trials. Criteria for selection included investigator and core permanent staff experience, public health measures in place for COVID-19, import/export requirements for study drug and biological specimens, a clear and accelerated ethical and regulatory approval process for COVID-19 trials. Training was tailored and delivered according to the experience level of the investigator and site staff, and included GCP training, standard operating procedures (SOP) fundamentals, conducting vaccine trials, COVID-19 pathophysiology, and vaccine trials lessons learned. Most of the grant funds were utilized for space expansion and renovation (46 %) followed by purchase of equipment (36 %); the remaining 18 % was spent on human resources. By the end of this site readiness initiative project, which took approximately 4 months, 21 of 22 (95 %) sites had agreements in place or were in discussions with sponsors to conduct large scale COVID-19 vaccine trials.