FDA: Using Diverse Data Streams to Understand and Respond to COVID-19

FDA has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions. The FDA and Aetion aim to answer questions about the use of diagnostics and medications in the pandemic, and risk factors for COVID-19-related complications in different patient populations.

We believe that this work has the potential to contribute to the scientific evaluation of potential diagnostics and interventions for COVID-19.

The FDA continues to work around the clock to respond to the COVID-19 pandemic.

As part of this effort, we recognize the potential for diverse, real-world data sources such as electronic health records, insurance claims, patient registries and lab results to further inform our science-based, all-of-America response to this unprecedented public health emergency.

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.

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