FDA officials call for including adolescents in adult oncology trials


20 December 2016 - A team of officials at the US FDA are calling for a "culture shift" by drug makers, regulators and clinical investigators to encourage enrolling more adolescent patients in relevant "adult-type" cancer clinical trials.

The officials made the call in a recent article in Clinical Cancer Research, where they argue that excluding older adolescents, ages 12 to 17, from adult oncology trials leads to delayed access to new treatments for those patients.

"In order to facilitate earlier access to investigational and approved drugs for adolescent patients with cancer, and because drug exposure is most often similar in adolescents and adults, we recommend the inclusion of adolescents (ages 12-17) on disease and target-appropriate adult oncology trials," the officials write.

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Michael Wonder

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Michael Wonder