Food and Drug Administration Commissioner Scott Gottlieb recently took aim at sponsors and CROs for their “continued reluctance” to deploy more innovative approaches to clinical trials, FierceBiotech reports.
Gottlieb, who is set to resign next month, says the agency has opened the door for more robust clinical development, but sponsors remain stagnant due to outdated business models.
“Unfortunately, we’ve seen a continued reluctance to adopt innovative approaches among sponsors and clinical research organizations,” Gottlieb said in a statement. “In some cases, the business model adopted by the clinical trial establishment just isn’t compatible with the kind of positive but disruptive changes that certain innovations can enable.”
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