Tocilizumab COVID-19 Study Shows Bias Against Observational Studies, Harvard Prof Says
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.
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The RECOVERY trial has found Actemra to help cut deaths and speed recovery – and UK doctors are not waiting for Roche to complete own studies.
Effort to replicate clinical trial results with real-world data could eventually allow for increased use in drug development.
Industry reps are glad that Birenbaum, who was the chief cannabis policy advisor to the governors of New York and Rhode Island, was given a prominent role at FDA that could spur regulatory action.