SESSION KEYNOTE

Keynote 3: Innovative Real World Evidence Initiatives at FDA in response to the COVID-19 pandemic 
Speaker: Aloka Chakravarty, PhD, FASA
Moderator: William Wang

Clinical data collected outside of traditional clinical trials—also known as “real-world data”— can provide insights to FDA on how COVID-19 treatments, diagnostics, and vaccines are performing in a variety of clinical settings. The reliability and utility of real-world data depend on the application of rigorous analytical methods as well as validation and cross-checking of analyses.  Through the Evidence Accelerator and other initiatives in the therapeutics and devices domains, FDA has collaborated to provide a unique venue for major data organizations, government and academic researchers, and health systems to share quickly insights, compare results, and answer curated key questions about COVID-19 treatment and response. In addition, the collaboration provided insights into understanding of disease, severity categorization, treatment characterizations and outcomes ascertainment.  In this presentation, we will highlight, through use of case examples, how FDA utilized parallel analysis, rapid-cycle queries, and other collaborative mechanisms simultaneously to respond to the evolving questions during the pandemic.

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