PRIM&R’s Comments on FDA’s Draft Guidance on Considerations for Inclusion of Adolescents in Adult Oncology Clinical Trials

PRIM&R recently submitted comments in response to the Food and Drug Administration (FDA)’s draft guidance “Considerations for Inclusion of Adolescent Patients in Adult Oncology Clinical Trials,” which was published in the Federal Register on June 4, 2018.

We applaud the draft guidance’s recommendation that adolescent patients with cancer be enrolled in disease- and target- appropriate adult oncology research, provided certain conditions are met. Presently, adolescents with cancer need to wait for a pediatric trial to begin after a late-phase adult trial is completed, delaying access to what could be a potentially effective treatment. Such delays also slow down the pace of developing data about safe and effective treatments for adolescent cancer patients.

We urge the FDA to recommend that sponsor’s evaluation of the relevant safety data be provided in a format that the investigator can share with the IRB so they may make an informed decision as to whether offering adolescent subjects the opportunity to enroll in an adult oncology trial is ethical.

The guidance document currently recommends that when it comes to first-in-human or dose-escalation trials, initial adult pharmacokinetic and toxicity data must already be available before adolescents are enrolled in adult trials. Sponsors are instructed to consult with the relevant FDA review division about the type and amount of adult data that is necessary.

PRIM&R believes that once the FDA has determined that the requisite data exists for the research to safely begin, there are still a number of considerations for an investigator and an IRB to review before they decide it is appropriate to ask adolescents if they would like to enroll in an adult trial. An IRB’s access to the sponsor’s evaluation of the safety data will help it determine not only whether including adolescents in such research may benefit the intended population, but also whether the risks those potential subjects face is acceptable considering the alternative treatments currently available for the population.

We also suggest that the FDA include language in the draft guidance reminding readers that its recommendations are only meant to address the inclusion of adolescent patients in adult oncology trials and that they should not assume that the guidance’s considerations will necessarily be applicable in research pertaining to other diseases, especially without consulting the agency.

Ultimately, though, PRIM&R believes the guidance is yet another welcome signal from the FDA on their increasing commitment to improving clinical trial access for demographic groups who have historically been excluded. (For more, see PRIM&R’s Comments on FDA’s Draft Guidance on Enrolling Pregnant Women in Clinical Trials.)