Eligibility Requirements for Trials

Adolescents are generally not eligible for enrollment in adult oncology trials. Instead, 18 years of age is set as the minimum age without analysis or explanation.

For kids and teens with untreatable cancers, this is a life threatening exclusion. The policy especially does not make sense for large 17 year olds who may be taller and heavier than other qualifying adults. The policy also does not make sense for any child who is excluded from a trial for reasons other than scientific and medical rationales.

The FDA has recently published two guidances encouraging companies to lower minimum ages of eligibility for adult cancer trials:

FDA Guidance for Industry: Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs"