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Will COVID Finally Help US FDA And Sponsors Overcome Their ‘Angst’ On Innovative Trial Designs?

 
• By Derrick Gingery

The ‘sea change’ inside White Oak should be seen as very encouraging for sponsors, FDA official says.

BIO International Convention clinical trial lessons learned screenshot
FDA and industry experts discuss clinical trial design lessons learned from the COVID-19 pandemic during the BIO International Convention. • Source: Screenshot

The coronavirus pandemic managed to change minds at the US Food and Drug Administration about innovative clinical trial designs, an attitude many hope remains once the public health emergency ends.

Safety and travel restrictions forced sponsors, as well as the FDA, to incorporate remote monitoring and other largely untested approaches...

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