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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Even if the agency had the legal power, it likely did not have the resources to oversee all clinical trials, rather than only those that qualified under the IND regulations, but the extra oversight could have increased coordination and ensured more data was fit for regulatory purposes.
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.
Even though many approaches were successful, the agency may need a couple years to determine if the data generated were actionable.