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Tocilizumab COVID-19 Study Shows Bias Against Observational Studies, Harvard Prof Says

 
• By Brenda Sandburg

Study showing Roche’s Actemra decreased mortality in COVID-19 patients in ICUs by almost 10% was initially rejected by journal editors and then ignored by guideline writers and regulators. FDA officials and industry reps discuss what needs to be done to advance use of real-world evidence from observational studies.

observational eye
Observational study of COVID-19 treatment was largely ignored by the scientific community • Source: Shutterstock

The US Food and Drug Administration is evaluating the potential role of observational studies in demonstrating drug product effectiveness. However, the response to an observational study of Roche Holding AG’s Actemra (tocilizumab) for COVID-19 patients shows the hurdles such studies face in gaining acceptance.

Miguel Hernán, professor of biostatistics and epidemiology at Harvard T.H. Chan School of Public Health, described the study he and his colleagues conducted in 3,942 individuals with COVID-19 in intensive...

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