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Regulatory Focus – FDA, Aetion partner on real-world data analytics for COVID-19

Regulatory Focus – FDA, Aetion partner on real-world data analytics for COVID-19

The US Food and Drug Administration (FDA) on Tuesday said it will partner with New York-based health technology firm Aetion, Inc. to develop real-world data analytics to answer pressing questions related to coronavirus disease (COVID-19).

“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,” said FDA Principal Deputy Commissioner Amy Abernethy.

The collaboration will rely on Aetion’s Evidence Platform to analyze real-world data sources such as electronic health records, insurance claims, patient registries and lab results to help inform the agency’s response to the pandemic.

“We can use current data and learn what decisions we can confidently make now, and we can learn what we’ll need to do in the future as more data become available,” Abernethy said.

Founded in 2013 by Harvard Medical School faculty, Aetion has previously worked with FDA on research investigating how real-world evidence can be used to inform regulatory decision-making and counts former FDA Commissioner Scott Gottlieb as a member of its board of directors.

FDA says the collaboration fits in with other efforts to pull data from different sources amid the pandemic, including its Sentinel initiative and the Reagan-Udall Foundation and Friends of Cancer Research COVID-19 Evidence Accelerator.…