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Real-World Evidence Likely Untainted By COVID-19 Journal Article Debacle

 
• By Sue Sutter and Sarah Karlin-Smith

Retraction of Lancet, NEJM studies does not signal doubts about the utility of RWE for evaluating drug efficacy and safety; instead, it highlights importance of transparency, validation and audit trails for real-world datasets, and lack of familiarity with RWE methods among medical journal peer reviewers, experts say.

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Researchers and journal editors may want to proceed with caution when a real-world dataset seems too good to be true. • Source: Shutterstock

The prominent retraction of two observational studies on COVID-19 is unlikely to permanently taint interest in leveraging real-word evidence about drug efficacy and safety.

The withdrawal of the studies in the Lancet and New England Journal of Medicine, both led by Brigham and Women’s Hospital cardiologist Mandeep Mehra and relying on data from a small, little-known firm called Surgisphere Corp

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