“The Food and Drug Administration (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, the FDA’s Principal Deputy Commissioner. “We also recognise that Covid-19 is a dynamic situation.”
The partnership, which came about as a result of the Covid-19 Evidence Accelerator initiative, aims to look at safety and effectiveness of treatments, vaccines, and diagnostics by using data obtained from electronic health records, insurance companies and other medical sources.
“As regulators and industry mobilise to address Covid-19, it’s critical that we learn from the data generated by the healthcare system,” said Aetion’s 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."