FDA, partnering with New York health tech firm, seeks to collect ‘real-world’ data on Covid-19 - STAT

The Food and Drug Administration said Tuesday that it will launch a new research project focused on real-world evidence — data collected by insurance companies, in electronic health records, and in other places in medicine — to learn more about Covid-19, including how diagnostics and medications are being used in the pandemic and how best to design studies to test them.

The project is a collaboration with Aetion, a New York health tech startup that specializes in real-world evidence.

“Right now, I think that the most intriguing part of the Aetion story is the ability to have a very consistent analytic approach that can be applied across multiple datasets,” Amy Abernethy, the FDA’s principal deputy commissioner, said in an interview. 

The exact questions the collaboration will explore are yet to be determined, Abernethy said, but she said the agency felt it had to “pressure test” the company’s technology.

The partnership emerged from the Covid-19 Evidence Accelerator, an initiative between the Reagan-Udall Foundation and Friends of Cancer Research that allowed teams from government, academia, and industry to present real-world evidence efforts to one another. 


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