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PERSPECTIVE article

Front. Pediatr.
Sec. Children and Health
Volume 12 - 2024 | doi: 10.3389/fped.2024.1481754

Engaging children and adolescents in the design and conduct of paediatric research

Provisionally accepted
Barbara E. Bierer Barbara E. Bierer 1*Elisa Koppelman Elisa Koppelman 1Alysha Croker Alysha Croker 2Sharareh Hosseinzedah Sharareh Hosseinzedah 3Collin Hovinga Collin Hovinga 4Steven Joffe Steven Joffe 5Gianna McMillan Gianna McMillan 6Robert Nelson Robert Nelson 7Christina Bucci-Rechtweg Christina Bucci-Rechtweg 8Dominik Karres Dominik Karres 9
  • 1 The Multi-Regional Clinical Trial Center, Boston, United States
  • 2 Health Canada, Ottawa, Ontario, Canada
  • 3 Independant, Toronto, Canada
  • 4 Critical Path Institute, Tucson, Arizona, United States
  • 5 University of Pennsylvania, Philadelphia, Pennsylvania, United States
  • 6 Independant Patient & Patient Advocate, Los Angeles, United States
  • 7 Johnson & Johnson, Spring House, PA, United States
  • 8 Novartis (United States), East Hanover, New Jersey, United States
  • 9 Division of Human Medicines, European Medicines Agency, Amsterdam, Netherlands

The final, formatted version of the article will be published soon.

    The importance of patient engagement in product development and clinical research is widely acknowledged in clinical research. In pediatrics, parents and guardians are often vocal advocates for their children in the process, but investigators and sponsors rarely directly solicit children's or adolescents' perspectives in clinical research planning or as patient partners during the conduct of research. Here, we provide compelling reasons and recommendations for investigators and sponsors to systematically engage young people in the design, conduct, and review of research, and the premise that input will be incorporated as a routine expectation. We consider the theoretical, ethical, and practical implications of this approach.

    Keywords: Paediatrics, Patient perspective, patient engagement, Product development, regulatory approval

    Received: 16 Aug 2024; Accepted: 14 Oct 2024.

    Copyright: © 2024 Bierer, Koppelman, Croker, Hosseinzedah, Hovinga, Joffe, McMillan, Nelson, Bucci-Rechtweg and Karres. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Barbara E. Bierer, The Multi-Regional Clinical Trial Center, Boston, United States

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.