US FDA’s COVID Master Protocol Guidance To Maintain Influence Post-Pandemic

Agency seeking comment on document intended to replace the just-issued guidance on COVID-19 treatment development as FDA stresses the value of master protocols for developing clinical knowledge.

Clinical research — Drugs evaluated in a master protocol are expected to have already been tested in humans, the FDA said in the guidance. • Source: Alamy

Guidance encouraging sponsors to use master protocols for coronavirus drug development also will influence US Food and Drug Administration policy on the clinical trial strategy going forward.

The FDA released a final guidance on 17 May as a COVID-19-focused document, which would remain in effect until...