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FDA’s perspective on RWE for COVID-19 and beyond: A conversation with Dr. Amy Abernethy from the 2020 Aetion Summit


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At the second annual Aetion Summit, “Evidence at the Apex,” in October 2020, Aetion virtually convened global biopharma and health care industry leaders for three days of conversation around real-world evidence (RWE), and how it can support decision-making in the era of COVID-19.

 

The Summit concluded with a conversation between Amy Abernethy, M.D., Ph.D., Principal Deputy Commissioner of Food and Drugs and Acting Chief Information Officer at the U.S. Food and Drug Administration (FDA), and Jeremy Rassen, Sc.D., Co-Founder, President, and Chief Science Officer of Aetion. 

 

In their discussion, Dr. Abernethy explained how real-world data (RWD) can support safety monitoring for COVID-19 vaccines, the value the FDA sees in RWE partnerships like the research collaborative agreement it signed with Aetion to improve understanding of COVID-19 with RWD, and how she sees the FDA’s use of RWE continuing to evolve after the end of the pandemic. 

 

She shared the agency’s “aha moment” with regards to COVID-19 and RWE: “Historically, we've talked about RWE as if it was a small group of research methods and types of questions that could be answered. The biggest post-pandemic change is this broad widening of our thinking about how RWD can answer many types of questions.”

 
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