FDA Partners With NY Health Tech Firm to Collect Real-world COVID-19 Data

The FDA announced a new research project to collect real-world data from insurance companies and electronic health records on the use of diagnostic tests and medications for COVID-19. The agency is partnering with New York–based health tech company Aetion for the project.

Together, the FDA and Aetion hope to use advanced analytic techniques to understand how COVID-19 presents and is treated among different patient populations, identify risk factors for coronavirus-related complications, and evaluate the outcomes of potential interventions. The collaboration will make use of the Aetion Evidence Platform, which will make it possible to facilitate sharing and reproduction of findings.

“The urgency of addressing the COVID-19 pandemic has demanded that we expand our work to identify, access, and analyze new data sets to widen the breadth of the information available,” said FDA Principal Deputy Commissioner Amy Abernethy MD, PhD, in a statement.

The partnership was a result of the FDA’s participation in the COVID-19 Evidence Accelerator, an initiative of the agency’s Reagan-Udall Foundation and the Friends of Cancer Research. The Accelerator brings together experts from government, academia, and industry to collaborate on gathering and sharing real-world evidence on the pandemic. The Evidence Accelerator initiative has two components: the Therapeutic Evidence Accelerator (launched in April) and the Diagnostics Evidence Accelerator (launched in June).

Sources: STAT, May 19, 2020; FDA press release, May 19, 2020; Aetion press release, May 19, 2020; FDA press release, June 18, 2020.