US FDA Welcomes Variety Of Phase II/III Trial Designs For COVID-19 Therapies, But With Standards
Executive Summary
Final guidance on COVID-19 treatment development emphasizes need for clinical endpoints to reflect drug mechanism, patient population, clinical setting and fast-evolving standard of care – with a cautious embrace of platform and adaptive designs.
You may also be interested in...
COVID-19 Should Force ‘Soul Searching’ Over Fragmented US Clinical Trials System, Woodcock Says
Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or underenrolled, Operation Warp Speed’s Janet Woodcock says, renewing her pitch for adoption of master protocols and other approaches to streamline studies and improve efficiency.
Pediatric Study Plans For Coronavirus Therapies To Get Trans-Atlantic Streamlining
EMA and US FDA offer sponsors help in completing their pediatric study plan templates and identifying areas of overlap between the two agencies requirements.
For COVID, Consensus On Value Of Platform Trials, But A Confusion Of Consortia
The coronavirus pandemic could be a turning point for master protocol and platform trial designs, but clear guidance and coordination are still needed.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: