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.
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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.
Dozens of specially outfitted RVs will roll out to long-term care facilities in the US to test the prophylactic and symptom-reducing potential of the antibody Lilly is developing with AbCellera.
COVID-19 has helped demonstrate the viability of platform trials with a shared control arm. That model is easier to extol than it is for sponsors to embrace, especially outside of crisis mode.