ACTIV Picks Potential COVID-19 Therapeutics To Be Tested In Master Protocol Trials
Three host-targeted immune modulators, three anticoagulants, and three to six neutralizing antibodies are to be tested in ACTIV clinical trials, FNIH's David Wholley tells DIA meeting.
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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.
Former FDA Commissioners Muse On Vaccine Surveillance – And The Next Operation Warp Speed
On the question of whether the US review of COVID vaccines is moving too slow compared to the UK, 'This is a lot of falderol,' Califf said.
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.