Authors: Jeff Allen, PhD1; Carla Rodriguez-Watson, PhD, MPH2
1Friends of Cancer Research
2Reagan-Udall Foundation for the FDA
Real-world data (RWD) have helped advance the nation’s ability to respond to the COVID-19 global pandemic by providing situational awareness and expanding the capacity to conduct post-market studies of the safety and effectiveness of COVID-19 diagnostics and therapeutics. The COVID-19 Evidence Accelerator1 is an initiative launched by the Reagan-Udall Foundation for the Food and Drug Administration (FDA Foundation),2 in collaboration with Friends of Cancer Research (Friends)3 and on behalf of the FDA, to provide a unique venue for major data organizations, government and academic researchers, and health systems to share information about COVID-19 efforts, and to convene a community to urgently address questions about COVID-19. The Evidence Accelerator is just one example of how the FDA is leveraging RWD, which intersects with RWD efforts at the FDA and other government agencies (see Figure 6.1).
Figure 6.1. Leveraging RWD at the FDA and other government agencies
The Evidence Accelerator includes over 250 organizations that represent health services research, regulatory science, academia, government, regulated industry, technology companies, and health care analytic companies.
The Evidence Accelerator community comes together in two ways on three main workstreams: Therapeutics, Diagnostics, and Vaccines (Figure 6.2). For each of these workstreams, the two pillars of the COVID-19 Evidence Accelerator are Lab Meetings and Parallel Analysis (PA).
Figure 6.2. The Evidence Accelerator Community