FDA Grand Rounds: Advancing the Science of Real-World Data to Address the COVID-19 Pandemic, presented by Amy P. Abernethy, MD, PhD; Principal Deputy Commissioner (FDA), September10, 2020 from 12noon-1pm, Virtual, CE Available

FDA Grand Rounds

Advancing the Science of Real-World Data to Address the COVID-19 Pandemic

Thursday, September 10, 2020

12:00 p.m. - 1:00 p.m. EST

Webcast Only

Register here for webcast (public attendees and FDA staff)

CE Credit Available

Presented by: 

Amy P. Abernethy, MD, PhD 

Principal Deputy Commissioner

Acting Chief Information Officer

US Food and Drug Administration

About the Presentation:

The 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.

What you’ll learn from the FDA Deputy Commissioner: 

• The mission and goals of the FDA-RUF evidence accelerator collaboration. 
• The importance of the FDA’s RWE program- past, present, and future- and its uses for advancing RWD/E science.
• Optimal use cases for RWD/E and where these data are most fit-for-purpose