FDA and AdComm Members Agree that Pediatric Oncology Trials Need to Move Faster

Dose optimization for pediatric cancer drug trials shouldn’t rely on exhaustive analyses of toxicity, the FDA says, and members of an advisory subcommittee on pediatric oncology agree that children can’t wait for every question to be answered.

Accepted methods of identifying the dose that is most effective and least toxic for children include extrapolating data from adult trials, conducting early-phase pediatric trials and using model-informed drug development, the agency pointed out in its briefing document for the June 16 meeting of the FDA’s Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee.

But pediatric cancer researchers need to identify their optimal doses more quickly and accelerate the pace of drug development, according to several physicians and academics speaking at the meeting.

“We don’t need to wait for a final optimized adult dose before we can embark on pediatric development,” said Steven DuBois, director of experimental therapeutics at Dana-Farber/Boston Children’s Hospital. “We have an ethical obligation to a minor participant that there be some potential prospect for benefit,” DuBois said.

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