Aetion has signed a research collaboration agreement with the U.S. Food and Drug Administration to use real-world data to advance the understanding of and response to coronavirus disease (COVID-19).
The research will support the FDA’s 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.
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 intervention. Aetion and the FDA 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 healthcare system,” said Aetion CEO Carolyn Magill. “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.”
There are more than 300 COVID-19 vaccines in planning and trial stages, so researchers face unique challenges in clinical trial planning and recruitment; thus, agencies need relevant and timely real-world data—and the transformation of these data into valid real-world evidence—more than ever.
“COVID-19 has delivered an unprecedented shock to the healthcare system and brings new urgency to how we analyze real-world patient experiences. By conducting real-world evidence studies that apply the highest scientific standards, we can support the FDA as it advances an evidence-based understanding of COVID-19,” said Aetion Co-founder, President, and Chief Science Officer Jeremy Rassen, Sc.D.
Read the original press release here.
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