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COVID-19 Should Force ‘Soul Searching’ Over Fragmented US Clinical Trials System, Woodcock Says

 
• By Sue Sutter

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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After COVID, there is going to be some soul searching for a better way to collect clinical evidence. • Source: Shutterstock

The COVID-19 pandemic is highlighting longstanding inefficiencies in the US clinical trials enterprise, the result being that only a small fraction of ongoing studies for potential therapeutics are expected to produce actionable data, Operation Warp Speed’s Janet Woodcock says.

Woodcock, who is on temporary leave as director of the Food and Drug Administration’s Center for Drug Evaluation and Research...

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