FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts

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FDA Takes Additional Action to Harness Real-World Data to Inform COVID-19 Response Efforts

Today the U.S. Food and Drug Administration has taken an additional step in harnessing real-world data to help inform the agency’s overall response to the COVID-19 public health emergency. The FDA is announcing its participation in the COVID-19 Diagnostics Evidence Accelerator, a multi-stakeholder collaborative project to advance the development of diagnostics. The Diagnostics Evidence Accelerator is organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. “While there are current studies of viral diagnostic and antibody tests using traditional assessment methods, the Diagnostics Evidence Accelerator will allow the community to analyze both diagnostic and clinical data in real time, which has the potential to contribute to the scientific evaluation of diagnostic tools and medical interventions for COVID-19,” said Amy Abernethy, M.D., PhD., FDA Principal Deputy Commissioner. “FDA’s participation in the Diagnostics Evidence Accelerator is another example of how we are working with a broad set of experts in healthcare data and analytics to understand the performance of SARS-CoV-2 tests and to inform clinical and public health decision-making.” The Diagnostics Evidence Accelerator is the companion project to the previously announced Therapeutic Evidence Accelerator, which brings together leading experts in health data aggregation and analytics in a unified, collaborative effort to...

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