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Adolescents to be included in Adult Oncology Trials

Adolescents to be included in Adult Oncology Trials

FDA has issued a draft guidance for including adolescents in adult oncology trials and has asked to provide recommendations to industry on how to do so. The draft guidance has been issued to address the issue that adolescent patients, ages 12 to 17, “should be eligible for enrollment in adult oncology clinical trials at all stages of drug development” when the cancer being studied or the molecular target of the drug under investigation is the same in both adults and adolescents. as published in a 2016 article in Clinical Cancer Research.
According to FDA, “Adolescents, because of their age, generally are not eligible for enrollment in adult oncology trials, and the initial pediatric trials for many drugs are conducted years later, often after the drug is approved in adults due to which it leads to delayed access to potentially effective treatments for adolescent patients and makes enrolling adolescent patients in pediatric trials after approval more difficult as many adolescent patients will be given the treatment off-label rather than wait to participate in a study.

Some of the recommendations laid down by draft guidance are such as:

  1. Recommendations given for the appropriate inclusion criteria; dosing and pharmacokinetic (PK) evaluations; safety monitoring; and ethical requirements for enrolling adolescent patients in adult oncology trials.
  2. No specific recommendations for adolescent inclusion in early stage trials. i.e. adolescents should be eligible for studies at all stages of development
  3. Adolescents should only be enrolled in first-in-human or dose-escalation trials after initial adult PK and toxicity data are obtained.
  4. Adolescent patients should only be enrolled in early phase trials when they have relapsed or refractory cancer, or a cancer with no curative standard treatment available.
  5. Appropriate dose for adolescents should be based on whether the adult dose is adjusted for body size or fixed.
  6. Adolescents should receive the same body size-adjusted dose as adults in case of drugs with an adjusted dose
  7. Sponsors should define a minimum weight threshold to prevent smaller than average adolescents from exceeding the intended exposure to the drug for fixed dose drugs
  8. Sponsors should pay close attention to any age-related differences in safety data
  9. Sponsors should have a plan for evaluating potential developmental toxicities.
  10. Institutional review boards (IRBs) reviewing trials that allow for adolescent enrollment must adhere to regulations under 21 CRF 50 subpart D, which lays out additional safeguards for children in clinical studies.