Aetion has signed a research collaboration agreement with the U.S. Food and Drug Administration (FDA) to use real-world data to advance the understanding of and response to coronavirus disease (COVID-19).
 
The research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns, by facilitating the use of relevant, novel data sources and analyzing these data according to well-established principles.
 
“The FDA is approaching the generation of real-world evidence for COVID-19 with a sense of urgency to learn what we can, as soon as we can, from patients who are receiving care right now,” said Amy Abernethy, M.D., Ph.D., principal deputy commissioner of food and drugs at FDA. “We also recognize that COVID-19 is a dynamic situation. 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.”
 
Aetion and the FDA will identify and analyze fit-for-purpose data sources to characterize COVID-19 patient populations and their medication use, identify risk factors for COVID-19-related complications, and contribute to the scientific evaluation of potential interventions. The collaboration will make use of the Aetion Evidence Platform, which includes structured workflows and transparent reporting to facilitate efficient sharing, examination, and reproduction of findings.
 
“As regulators and industry mobilize to address COVID-19, it’s critical that we learn from the data generated by the health care system,” said Carolyn Magill, CEO of Aetion. “This collaboration will employ Aetion’s analytic platform and a variety of real-world data sources to rapidly, reliably, and transparently produce actionable insights to serve patients and address the daily challenges they face.”