BioPharma, Artificial Intelligence

FDA, Aetion team up on real-world evidence research in Covid-19

The two plan to identify and analyze sources of real-world data that they can use to characterize populations of patients with Covid-19, their use of medicines, risk factors and to characterize potential interventions.

A firm that generates real-world evidence for the life sciences industry is teaming up with the Food and Drug Administration in a push to use real-world data to understand and respond to Covid-19.

New York-based Aetion said Tuesday that the partnership with the FDA would focus on assessing and analyzing real-world data sets to generate information about the course and treatment of the disease, as well as diagnostic patterns, using the company’s Evidence Platform system.

The effort will involve identifying and analyzing sources of data to characterize populations of patients with Covid-19, their use of medications, risk factors for complications related to the disease and to characterize potential interventions. Aetion said that the explosive growth of treatments and vaccines for Covid-19, and the resulting challenges in planning and recruiting participants for clinical trials, highlighted a need for real-world data and their transformation into real-world evidence.

“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,” FDA principal deputy commissioner of food and drugs Amy Abernethy said in a statement. “We also recognize that Covid-19 is a dynamic situation.”

The FDA has embraced use of real-world evidence for a while and collaborated with other institutions to explore its use, including with Aetion. Last April, for example, the agency expanded a project with the company and Boston’s Brigham and Women’s Hospital to use RWE to recreate randomized, controlled clinical trials. The expansion of the product sought to use it to predict the results of Phase IV clinical trials. Meanwhile, Aetion has built up a large roster of partnering companies an organizations, announcing last month that it had built on an existing partnership with HealthVerity to assess safety and effectiveness of Covid-19 interventions.

“As regulators and industry mobilize to address Covid-19, it’s critical that we learn from the data generated by the healthcare system,” Aetion CEO Carolyn Magill said in a statement. “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.”

Photo: shuoshu, Getty Images

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