Back to School: How biopharma can reboot drug development. Access exclusive analysis here

0909 BTS41 McClellan podcast
BioCentury & Getty Images

Back to School 2020

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

Sep 10, 2020 | 2:32 AM GMT

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

Read the full 2000 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury

SIGN UP

Article Purchase

This article may not be distributed to non-subscribers
More Info >PURCHASE