FDA to analyze real-world data on COVID-19

May 21, 2020

The U.S. Food and Drug Administration (FDA) has signed an agreement with Aetion, a vendor of an analytics platform, to assess real-world data about COViD-19, according to a news release from the agency.

The FDA and Aetion plan to collect and analyze information on patient outcomes from such sources as electronic health records (EHRs), insurance claims, patient registries, and lab results. 

“Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mitigate potential shortages. These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19,” Principal Deputy Commissioner Amy Abernethy, MD, PhD, said in a statement.

Abernethy said the new partnership is but one example of how the agency is using novel data sources in research. For example, the FDA participates in the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research, she said. The idea behind the effort is to develop common data elements and questions to spur the collection and analysis of real-world data.

New York-based Aetion’s analytics platform is used for by life science companies and healthcare payers.

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