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.
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Single neutralizing antibody moves to US FDA with data showing reduced hospitalization, while Lilly’s EUA filing for two-antibody combo awaits safety data and more certainty about production capabilities.
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.