Module232025

07/05/2025

Moves towards inclusion of adolescents

• Proposal from ACCELERATE 17 • include patients >12 in clinical trials where the mechanism of action of the drug being studied and the characteristics of the target disease are potentially relevant to adolescents • FDA has already signalled it may be willing to accept an application to approve a drug for patients aged 12 and older 18 • Recent publications describing the efficacy of a drug in a particular tumor type in adults and children 19 • Draft Guidance for Industry from FDA regarding inclusion of adolescents in adult oncology trials 20

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The developing autonomy of the adolescent

• A subject in a pediatric trial may already have accrued various legal rights in their country, e.g., to have sex, drive, marry, join the army. Do legal rights “beat” the protocol? “Mature minor” doctrine. • “As a matter of Law, the parental right to determine whether or not their minor child below the age of majority will have medical treatment terminates if and when the child achieves sufficient understanding and intelligence to understand fully what is proposed” 17 • Courts increasingly recognise the developing autonomy of adolescents. • Adolescents should be made aware of the information which will be shared with parents/ guardians, e.g., contraceptive use, pregnancy, drug use • Adolescent dissent should be respected, unless enrolment represents the “best” option for the adolescent. In many countries, a court order will be required to enrol the adolescent in such circumstances. • The CTR requires the dissent of a child of any age to be respected. • In the USA, dissent must be “considered”.

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