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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Early ‘Scattershot’ Approach To COVID-19 Therapeutic Research Generated Little Actionable Data
US FDA and NIH leaders cite lack of early clinical trial coordination as a weakness in the pandemic response that led to use of compounds that were potentially harmful and, even today, still not proven to be effective.
Pandemic Perspectives: US FDA ACTT’s On Its Faith In Randomized Trials With Veklury Approval Despite WHO Study
US FDA has not deviated from its bedrock trust in the value of ‘statistically reliable’ endpoints amidst the COVID-19 pandemic, the Pink Sheet’s Drug Review Profile of Gilead’s Veklury shows.
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.