When COVID-19 was declared a pandemic, the FHI Clinical team immediately grasped the challenges that the search for vaccines and treatments would present. We’ve been here before, addressing everything from the global threat of malaria to outbreaks of Ebola in West Africa, Zika in the Americas, and chikungunya in the Caribbean during the aftermath of Hurricane Maria. Our pandemic experience means that we know the steps to take and the critical questions to ask.
Rapid study start-up is crucial during outbreaks, and site selection is the vital first component. FHI Clinical teams carefully evaluate the epidemiological data to target particular regions and sites. We then assess if patients presenting at a given facility meet the entry criteria and determine:
Working closely with the site, we also assess whether it will allow a central institutional review board (IRB) review and whether it can support an expedited contract and budget execution. In this environment, we lean heavily on our vast web of trusted relationships so that we can achieve rapid, quality data collection leading to analysis and response decisions. FHI Clinical is especially well-placed in this process given our long history of establishing and sustaining sites — independent of an outbreak — that gives us a robust site network ready to deploy when needed.
Once the right sites are established, clinical trial management becomes the next priority. Staffing a trial in an outbreak requires unique expertise, and our vetted team structure allows us to rapidly deploy resources while maintaining the flexibility to respond to evolving, on-the-ground circumstances. It is important to maintain smaller ratios of full-time equivalents (FTEs) to sites, select key essential documents to be collected to trigger site activation and establish detailed remote site selection processes and training programs for site initiation.
Rather than customizing existing or developing new processes and procedures in the face of an infectious disease outbreak, we keep ourselves current and ready to address the next outbreak by investing in our intellectual capital and maintaining best practices, processes and procedures developed from our involvement with rapid outbreak responses.
For example, our current involvement with SARS-CoV-2 includes management and/or coordination of multiple global studies, including a large Phase II treatment trial with an adaptive-design protocol, for which the team (as of May 4, 2020) enrolled 1,063 participants over 58 days at 68 sites in 10 countries in Europe, East Asia, Southeast Asia, North and Central America.
Phase II SARS-CoV-2 study
- Treatment trial
- Adaptive-design protocol
- Enrolled 1,063 participants over 58 days
- 68 sites in 10 countries globally
(as of May 4, 2020)