Module232025

12/05/2025

Benefits of Including Adolescents into Adult Trials

Accelerate marketing authorization of an effective drug in the adolescent population at the same time of adult approval Access to new medicines earlier on for the adolescent and subsequently for the paediatric population

Shorten and orientate the full paediatric drug development time and the overall duration of drug development Increase the likelihood of achieving proof of concept/proof of principal for drugs with brand new MoA

Might positively influence adult drug development of a given drug

Reduce off-label use

Increase knowledge in adolescent drug efficacy/resistant mechanisms, giving rational for further development of molecular driven trial and personalised medicine

Increase innovative trials for adolescents

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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Summary and Conclusion

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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