How the Surgisphere scandal was a warning for real-world evidence
In May, a study in The Lancet seemed to raise new warnings about hydroxychloroquine, leading many clinical trials of the drug to pause or stop. But then the study was retracted only weeks later as questions swirled around Surgisphere, the unknown company that created it.
"In the real world data committee there has long been a worry that this type of event would happen, and sure enough it happened early in the pandemic," said Amy Abernethy, the principal deputy commissioner at the Food and Drug Administration. "Although, maybe it was the event we needed to have happen in order to force some critical activities."
Abernethy made the comments during a STAT virtual event about real-world evidence, the field of trying to improve how data from outside clinical trials can collect medical evidence. Her message, and that of other panelists: this type of science is hard, but the Covid-19 pandemic represents a unique opportunity to use it — and so-called "real-world data" can help doctors better understand this new disease.
"In the real world data committee there has long been a worry that this type of event would happen, and sure enough it happened early in the pandemic," said Amy Abernethy, the principal deputy commissioner at the Food and Drug Administration. "Although, maybe it was the event we needed to have happen in order to force some critical activities."
Abernethy made the comments during a STAT virtual event about real-world evidence, the field of trying to improve how data from outside clinical trials can collect medical evidence. Her message, and that of other panelists: this type of science is hard, but the Covid-19 pandemic represents a unique opportunity to use it — and so-called "real-world data" can help doctors better understand this new disease.
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