FDA joins multi-stakeholder effort to leverage real-world data in COVID-19 diagnostic testing space

The US FDA has announced its participation in the COVID-19 Diagnostics Evidence Accelerator initiative, to leverage real-world data to help answer key questions concerning SARS-CoV-2 diagnostic and antibody testing and help inform its response against COVID-19.

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The US FDA has announced its participation in the multi-stakeholder COVID-19 Diagnostics Evidence Accelerator initiative – a collaborative project organized by the Reagan-Udall Foundation for the FDA and Friends of Cancer Research (both DC, USA) – to leverage real-world data to help answer key questions concerning SARS-CoV-2 diagnostic and antibody testing. The move represents a further step in the agency’s effort to harness real-world data to inform its response against COVID-19.

Amy Abernethy, Principal Deputy Commissioner at the FDA, explained: “The Diagnostics Evidence Accelerator is a significant step toward harnessing the full potential of real-world data to tackle the COVID-19 pandemic. Leveraging real-world data collected from patients can contribute to our scientific evaluation of viral diagnostic and antibody tests, gain a deeper understanding of the prevalence of SARS-CoV-2 in specific populations and potentially answer critical questions on immunity.”


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Complementing and building on the methodology of the COVID-19 Therapeutic Evidence Accelerator project announced in April, the COVID-19 Diagnostics Evidence Accelerator will unite stakeholders in weekly meetings to harness and analyze real-world data to help tackle key research questions concerning the real-world performance of SARS-CoV-2 diagnostic and antibody tests.

Real-world data will be leveraged to help inform real-time surveillance of COVID-19, chains of disease transmission and even whether the presence of antibodies against SARS-CoV-2 can indicate future immunity against the virus. The project could also be important for helping inform the response efforts of the FDA in future emergencies, supplementing data that could help determine whether Emergency Use Authorizations for certain diagnostics should be granted.  

Jeff Shuren, Director of the FDA’s Center for Devices and Radiological Health, commented: “We recognize that questions related to the accuracy of diagnostic tests require different data elements that are not as widely available as those in the therapeutic space. They also require a different approach to data integration and analysis.”

“The aim of the Accelerator is to propose questions, refine them, evaluate the feasibility of different approaches, and bring together groups that have the data to answer the questions and develop lasting solutions. Ultimately, we hope that real-world data can provide a more generalizable and rapid read-out of results than traditional clinical trials,” concluded Shuren.


Sources:

www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-additional-action-harness-real-world-data-inform-covid-19; www.focr.org/news/new-covid-19-diagnostics-evidence-accelerator-applies-real-world-data-answer-urgent-questions

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