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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Drug Repurposing: FDA IND Authority Lacks Levers To Better Direct Trial Resources In A Pandemic
Office of New Drug Director Peter Stein says there needs to be a better way to facilitate drug repurposing to avoid wasting time and resources on theories with little scientific probability of success.
Curb Your Enthusiasm For Continued Use Of Pandemic Clinical Trial Flexibilities, US FDA Says
Even though many approaches were successful, the agency may need a couple years to determine if the data generated were actionable.
Woodcock Open To Endpoint Flexibility For Rare Diseases
Acting US FDA Commissioner also touts master protocols’ potential for rare diseases, arguing patient-funded foundations could overcome sponsor hesitancy to collaborate with potential rivals.