In an effort to harness diverse streams of data to understand and respond to COVID-19, the U.S. Food and Drug Administration (FDA)  has entered into an agreement with Aetion  to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions. FDA and Aetion aim to answer questions about the use of diagnostics and medications in the pandemic, as well as identify risk factors for COVID-19-related complications in different patient populations. FDA says it believes that this work has the potential to contribute to the scientific evaluation of potential diagnostics and interventions for COVID-19.

As part of its effort to respond to the COVID-19 pandemic, FDA says it recognizes the potential for diverse, real-world data sources such as electronic health records, insurance claims, patient registries, and lab results to further inform its "science-based, all-of-America response to this unprecedented public health emergency."

“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,” says Amy Abernethy, MD, PhD, 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.”

“In recent years, the agency has taken steps to leverage modern, rigorous analyses of real-world data — such as data from the healthcare setting — to inform our work,” FDA said in a statement. “The COVID-19 pandemic has brought an urgency to these efforts and the FDA has worked quickly to advance collaborations with public and private partners to collect and analyze a variety of real-world data sources. Evaluation of real-world data has the potential to provide a wealth of rapid, actionable information to better understand disease symptoms, describe and measure immunity and understand available medical product supplies to help mitigate potential shortages. These data can also inform ongoing work to evaluate potential therapies, vaccines or diagnostics for COVID-19.”

“As regulators and industry mobilize to address COVID-19, it’s critical that we learn from the data generated by the healthcare system,” says 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.”

FDA says it is applying data from diverse sources to inform its response to COVID-19, including sources that were already available to the agency, such as Sentinel . The urgency of addressing the COVID-19 pandemic has demanded that the agency expand its work to identify, access, and analyze new datasets to widen the breadth of the information available.

This work is being done in collaboration with partners in the U.S. government, academia, and industry.

For example, FDA is a participant in the COVID-19 Evidence Accelerator , organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. The COVID-19 Evidence Accelerator brings together leading experts in health data aggregation and analytics in a unified, collaborative effort to share insights, compare results, and answer key questions to inform the collective COVID-19 response. By developing common data elements and questions, the Evidence Accelerator creates a strong foundation for rapid collection and rigorous analysis of real-world data to answer urgent questions about COVID-19.