Module232025

12/05/2025

What is Needed to Achieve the Goal of Age Inclusive Clinical Trials?

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3 Increased collaboration among all involved stakeholders

2 Increased collaboration between paediatric and adult treating physicians

Change in Mindset

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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Conclusion

Adolescent Inclusion : Including adolescents in adult clinical trials or conducting parallel adolescent trials are vital methodological approaches for advancing drug development in paediatric patients, where scientifically and ethically justified. This should be the default in innovative product development. Age-Inclusive Research: Essential for developing effective healthcare strategies that meet the needs of all age groups.

Addressing Challenges : Challenges exist in involving adolescents in trials before the safety and efficacy of new medicines are established for adults. Timely Access to Medicines : Including adolescents in adult clinical trials is crucial for facilitating their timely access to new treatments, ultimately benefiting the entire paediatric population. It also helps shorten the overall duration of drug development.

Engagement and collaboration of all involved stakeholders are essentialfor success.

The Organisation for Professionals in Regulatory Affairs

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M Dehlinger-Kremer, 14 May 2025

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