Module232025

12/05/2025

Considerations for Including Adolescents in Adult Trials

Trial designs , endpoints , and assessment schedules should not unnecessarily exclude adolescents from participating in adult trials Adult protocols which are to include children should include paediatric specialists as investigators to provide expertise and help address logistic issues

Protocol Investigator

Trials involving children should use a central IRB/EC and/or ensure inclusion of paediatric expertise on the IRB/EC of record to help educate and support the committee members and assist in review of such studies

IRB/EC

Using established paediatric centres with drug development expertise and infrastructure would help mitigate the operational and regulatory challenges and lack of experience that might exist within

Centres

a primarily adult clinical centre. Ensure privacy for adolescents

Young children may not be able to swallow tablets or capsules. Development of paediatric friendly drug formulations for these populations should be considered early on otherwise, unnecessary delay in paediatric evaluation may occur

Formulation

The Organisation for Professionals in Regulatory Affairs

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Tool for Inclusion of Adolescents into Adult Trials - Based on Seven Factors Gating/Enabling Adolescent Inclusion*

Disease

Product

Statistical

Operational

Investigator & Site-focused

Identified as part of Horizon Scanning activity

Sponsor-focused

Legal & Ethical

*Tool developed by EFGCP

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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