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Pandemic Accelerates US FDA’s Use Of Real-World Data From Clinical Trial Design To Supply Chain

 
• By Brenda Sandburg

FDA’s Amy Abernethy describes how agency’s use of real-world data has evolved in response to COVID-19 and the ‘a-ha’ moment of leveraging different data sources to understand the coronavirus. Takeda R&D President Andrew Plump notes difficulties with platform trials and limitations on data sharing.

real world data
FDA is using real-world data to respond to COVID-19 pandemic • Source: Shutterstock

The US Food and Drug Administration has advanced the use of real-world data to tackle the COVID-19 pandemic, using it to understand the disease, plan clinical trials, and manage the medical product supply chain to prevent shortages.

Amy Abernethy, FDA’s principal deputy commissioner, described the evolution of the agency’s use of real-world data during the pandemic at the FDA/CMS Summit in December. She noted that it began...

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