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U.S. needs master protocols such as U.K.’s RECOVERY to speed COVID-19 evidence collection, McClellan says: a BioCentury audio interview
Former FDA chief also wants to see trials integrated into routine clinical practice
Former FDA and CMS chief Mark McClellan also wants to see clinical trials integrated into routine clinical practice
The establishment of clinical trial protocols for COVID-19 in the U.S. that emulate the U.K. RECOVERY trial — a streamlined protocol that facilitates participation by community hospitals and has generated data quickly — is imperative, according to Mark McClellan, director of the Duke-Margolis Center for Health Policy.
McClellan, a former FDA commissioner and CMS administrator, noted that “among the things that we've learned so far that really matter in COVID outcomes, especially for seriously ill patients, a lot of it has come from [the] RECOVERY trial.”
The U.K. master protocol has, among other things, identified dexamethasone as an effective treatment and definitively ruled-out benefit from hydroxychloroquine (see “Master Protocols”; “Oxford’s Landray Wants RECOVERY-type Trials to Go Well Beyond COVID-19”).
RECOVERY took a “page out of the book for progress on heart attacks a couple of decades