Article

Can Real-World Evidence Transform Healthcare? Recent FDA Activities Indicate Yes

Clinical Leader

19 Nov 2021

Stacy Cline Amin authored an article for Clinical Leader about how the COVID-19 pandemic has brought new urgency to the U.S. Food and Drug Administration’s (FDA) efforts to advance real-world evidence (RWE), which has the potential to transform healthcare delivery and drug development.

“COVID-19 has been the single greatest catalyst for the advancement of RWE,” Stacy wrote. “I lived through those dark early days of the pandemic, when the scientists at our public health agencies struggled to understand the virus – how it transmitted, how it impacted the body, and why some people responded so severely worse to infection than others.”

She added: “Without time for the gold standard of blinded controlled clinical trials, FDA had to pivot to finding and using data sources that it never previously would have relied on for regulatory decisions. Some of those decisions have been criticized in hindsight, but what everyone seems to agree on is that FDA desperately needed more access to more data.”

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