Stakeholders Seek Clarification of FDA’s Adolescent Oncology Patient Guidance

August 14, 2018

The FDA’s draft guidance on inclusion of adolescents in adult oncology clinical trials should clarify how the agency’s thinking aligns with international regulations, stakeholders said in comments on the June 1 draft.

The agency suggests that teens should be allowed to join adult oncology clinical trials as long as the cancer or the drug target is the same. Adolescents would be eligible for all phases of cancer trials if the FDA is satisfied with the pharmacokinetic and toxicity data for adults and provided sponsors adjust dosing for patients’ body size.

In its comments, PhRMA said it would encourage the FDA “to facilitate a broader conversation among the global regulatory community to promote adoption of similar pragmatic approaches.”

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