The Food and Drug Administration (FDA) continues to work around the clock to respond to the COVID-19 pandemic. As part of this effort, we recognize the potential for diverse, real-world data sources such as electronic health records, insurance claims, patient registries and lab results to further inform our science-based, all-of-America response to this unprecedented public health emergency.
In recent years, the agency has taken steps to leverage modern, rigorous analyses of real-world data—such as data from the health care setting—to inform our work. 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.
The FDA 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, BEST, and NEST. The urgency of addressing the COVID-19 pandemic has demanded that we expand our 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.
Amy P. Abernethy, MD, PhD
Principal Deputy Commissioner
Acting Chief Information Officer
US Food and Drug Administration