Module232025

12/05/2025

Challenges of conducting clinical trials in children

• Differences in manifestation and progression of diseases between adults and children

• Difficulties in measuring and interpreting age-appropriate endpoints

• Ethical considerations for protecting children from harm and providing information on medicine use

• In context of the 2024 Revision to the Declaration of Helsinki (article 19 and 20)

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Evolution of the legal framework for clinical trials in EU/EEA

Pre 2004: No harmonisation National rules, different processes in each Member State. Resulted in delays and complications

Clinical Trials Directive (EU 2001/20/EC) Some harmonisation, but national systems & processes varied Entered into application 1 May 2004

Clinical Trials Regulation (No.536/2014) Full harmonisation, collaborative assessment of multinational trials, single EU portal & database Applies as of 31 January 2022

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