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

Barbara E Bierer; Elisa Koppelman; Alysha K Croker; Sharareh Hosseinzadeh; Collin Hovinga; Steven Joffe; Gianna McMillan; Robert Nelson; Christina Bucci-Rechtweg

doi:10.3389/fped.2024.1481754

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

Front Pediatr. 2024 Nov 12:12:1481754. doi: 10.3389/fped.2024.1481754. eCollection 2024.

Authors

Barbara E Bierer^{1

2}, Elisa Koppelman¹, Alysha K Croker³, Sharareh Hosseinzadeh⁴, Collin Hovinga⁵, Steven Joffe⁶, Gianna McMillan⁷, Robert Nelson⁸, Christina Bucci-Rechtweg⁹

Affiliations

¹ Division of Global Health Equity, Department of Medicine, Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard, Brigham and Women's Hospital, Boston, MA, United States.
² Department of Medicine, Harvard Medical School and Brigham and Women's Hospital, Boston, MA, United States.
³ Health Canada, Centre for Policy, Pediatrics and International Collaboration at Health Canada, Ottawa, ON, Canada.
⁴ Global Head Clinical Patient Engagement, Chief Medical Office, Novartis Pharma, Toronto, ON, Canada.
⁵ Critical Path Institute (C-Path), Tuscon, AZ, United States.
⁶ Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States.
⁷ Independent Patient & Participant Advocate, Los Angeles, CA, United States.
⁸ Johnson & Johnson, Pediatric Drug Development, Spring House, PA, United States.
⁹ Maternal Health and Pediatric Regulatory Policy, Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States.

Abstract

The importance of patient engagement in product development and clinical research is widely acknowledged. 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 engagement; patient perspective; product development; regulatory approval.