NEW YORK, May 19, 2020 — 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.”
With over 300 COVID-19 treatments and vaccines in planning and trial stages, researchers face unique challenges in clinical trial planning and recruitment. Due to these constraints, the need for relevant and timely real-world data — and the transformation of these data into valid real-world evidence — has never been greater.
“COVID-19 has delivered an unprecedented shock to the health care system and brings new urgency to how we analyze real-world patient experiences,” said Jeremy Rassen, Sc.D., Co-Founder, President, and Chief Science Officer of Aetion. “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.”
Aetion is a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory agencies. The Aetion Evidence Platform® analyzes data from the real world to produce transparent, rapid, and scientifically validated answers on costs and outcomes. Founded by Harvard Medical School faculty with decades of experience in epidemiology and health outcomes research, Aetion informs health care's most critical decisions — what works best, for whom, and when — to guide product development, commercialization, and payment innovation into health care’s modern era.
Aetion is based in New York City, and backed by investors including New Enterprise Associates (NEA), Flare Capital Partners, Lakestar, Town Hall Ventures, McKesson Ventures, Sanofi Ventures, Amgen Ventures, UCB, and Horizon Health Services, Inc. Aetion along with partner, HealthVerity, recently launched the Real-Time Insights and Evidence system to enable real-world research for COVID-19 interventions. Learn more at aetion.com, and follow us at @aetioninc.