Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-collaborations-promote-rigorous-analyses-real-world-data-inform?utm_campaign=051920_Statement_FDA%20Collaborations%20Promote%20Analyses%20of%20Real-World%20Data%20for%20Pandemic%20Response&utm_medium=email&utm_source=Eloqua

Coronavirus (COVID-19) Update: FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response

The following is attributed to FDA Principal Deputy Commissioner Amy Abernethy, M.D., PhD

Today, we are announcing another step in our effort to harness diverse streams of data to understand and respond to COVID-19. The U.S. Food and Drug Administration has entered into an agreement with Aetion to collaborate on advanced analytical techniques to answer urgent coronavirus disease (COVID-19) research questions. The FDA and Aetion aim to answer questions about the use of diagnostics and medications in the pandemic, and risk factors for COVID-19-related complications in different patient populations. We believe that this work has the potential to contribute to the scientific evaluation of potential diagnostics and interventions for COVID-19. 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 ...

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