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Informed consent and assent guide for paediatric clinical trials in Europe

Pirkko Lepola1, Maxine Kindred2, Viviana Giannuzzi3

  • 1University of Helsinki and Helsinki University Hospital, Department of Children and Adolescents, Helsinki, Finland pirkko.lepola@hus.fi.

Archives of Disease in Childhood
|December 2, 2021
PubMed

Insights

A new guide simplifies informed consent (IC) for paediatric clinical trials in Europe. It standardizes documentation, improving ethical standards for child participants in multinational research.

Area of Science:

  • Clinical Trials
  • Pediatric Research
  • Regulatory Science

Background:

  • Multinational paediatric clinical trials face challenges due to dispersed populations and varying regulations.
  • Sponsors incur significant costs preparing informed consent (IC) and assent documentation for these trials.
  • Lack of detailed guidance complicates the IC process for paediatric clinical trials in Europe.

Purpose of the Study:

  • To develop an easy-to-use guide for informed consent in European paediatric clinical trials.
  • To make this guide publicly accessible on the European Medicines Agency's (EMA) Enpr-EMA website.
  • To support all stakeholders involved in paediatric clinical trial applications.

Main Methods:

  • Collated and analyzed current EU legal, ethical, and regulatory guidance for paediatric clinical trials.
  • Divided guidance into 30 subject elements presented in two tables.
  • Developed a three-level recommendation system with 'traffic light' symbols for four pediatric age groups, incorporating feedback from the European Network of Young Person's Advisory Group.

Main Results:

  • A comprehensive guide was created, containing general and trial-specific information tables.
  • For children aged 6-9 years, 92% of trial-specific elements are recommended for inclusion in IC discussions.
  • Even for the youngest group (2-5 years), an average of 52% of elements were considered for IC.

Conclusions:

  • The EU Clinical Trial Regulation lacks specific paediatric trial requirements.
  • This study provides the first extensive collation of legal, regulatory, and ethical documentation for paediatric IC, including adolescent input.
  • The developed guide has the potential to enhance ethical standards in paediatric clinical trials.
Abstract

Keywords:
ethicstherapeutics

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