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COVID-19 Shakes Up Real-World Data Studies

 
• By Sarah Karlin-Smith

US FDA hopes COVID-19 may finally spur data coding changes that will make real-world evidence projects proceed faster. The pandemic is now part of five real-world data projects using FDA's Sentinel system, but some other real-world data projects are paused due to the health crisis. The private sector is also changing the way it conducts real-world data work due to COVID-19.

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FDA and the private sector are jumping into real-world data projects to tackle COVID-19.

COVID-19 is leading to a plethora of real-world data projects at both the US Food and Drug Administration and in the private sector, ranging from research to try and anticipate oncoming shortages to studies of what approved treatments might be helping patients. Beyond the immediate utility of the research, FDA is also hopeful the urgent nature of the pandemic may finally be the push needed to encourage the adoption of interoperable data coding standards throughout the country.

FDA is relying on real-world data projects to elucidate COVID-19’s natural history, to track drug shortages during the crisis, and...

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