‘Resilient’ Trials: US FDA Wants To Apply COVID Lessons In Trial Design
The US FDA is not expecting sponsors to launch ‘pandemic-proof’ trials, but does want to see advance planning so that adaptations can be implemented for unexpected emergencies with ‘less burnout.’
You may also be interested in...
Routine inclusion of approaches such as local assessments and remote monitoring could reduce patient burden and avoid protocol deviations, but industry needs to see a return on investment, in the form of easier recruitment, better diversity and/or faster studies, experts said.
The investigator's ability to delegate trial-related activities to local HCPs could create operational and reimbursement challenges, as well as potentially boost patient recruitment, stakeholders said. The guidance does not address digital divide and how to deal with a massive influx of data.
Biopharma industry is making some modest headway in quest to change the new US Medicare drug price process to treat drugs and biologics on equal footing. But eliminating the so-called ‘pill penalty’ would not on its own equalize the incentives for small molecule and large molecule R&D.