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Mass Device – FDA launches COVID-19 research initiative

Mass Device – FDA launches COVID-19 research initiative

The FDA has entered an agreement with healthcare analytics company Aetion to research urgent questions about COVID-19.


The New York City-based company said the research will support FDA objectives to explore the natural history of the disease, as well as treatment and diagnostic patterns using 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 FDA principal deputy commissioner Amy Abernethy in a news release. “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, according to Aetion. The collaboration will use 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 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.”


Having real-world data on the novel coronavirus could also help investigators recruit for the more than 300 COVID-19 treatments and vaccines in planning and trial stages, researchers face unique challenges in clinical trial planning and recruitment, the company added.


The FDA is applying data from diverse sources to inform its response to COVID-19, including from its Sentinel national electronic system. The agency launched Sentinel in 2008 to help researchers monitor the safety of FDA-regulated medical products, including drugs, vaccines, biologics, and medical devices.


It is also working with the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research.

“We’re optimistic that these efforts will assist in, among other things, the FDA’s work to facilitate medical countermeasures to diagnose, treat and prevent COVID-19, mitigate any potential shortages in the medical product and food supply chains, ensure the safety and quality of FDA-regulated products and provide the industries we regulate the tools and flexibility to do the same,” Abernethy said.