COVID-19 Should Force ‘Soul Searching’ Over Fragmented US Clinical Trials System, Woodcock Says
Executive Summary
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.
You may also be interested in...
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.
FDA’s Pazdur Believes ‘Advanced Research’ Project Could Address Trial ‘Wastefulness’
ARPA-H could be a solution to some of FDA’s long-running complaints about US clinical trial infrastructure, the agency's cancer chief says.