Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process
Regulators from the jurisdictions represented in this WG are collaborating to facilitate regulatory harmonization and foster international alignment of pediatric CTs. By interacting with their respective regulatory bodies and developing expertise in their jurisdiction's regulatory requirements, national pediatric networks can support both academic and industry sponsors in navigating the regulatory process for CTs.
Authors
- Pamela Dicks (ORCID: https://orcid.org/0000-0002-1696-0757)
- Hidefumi Nakamura (ORCID: https://orcid.org/0000-0003-0191-2450)
- Donna L. Snyder
- Dionna Green
- Collin A. Hovinga
- Gunter F. Egger
- Andrew Davidson (ORCID: https://orcid.org/0000-0002-7050-7419)
- Thierry Lacaze‐Masmonteil
- Alysha Croker
- Faisal Ali (ORCID: https://orcid.org/0009-0008-1066-7446)
- Kanecia Obie Zimmerman (ORCID: https://orcid.org/0000-0003-3748-6932)
- Saul N. Faust (ORCID: https://orcid.org/0000-0003-3410-7642)
- I Villa
- Shaun Ramroop (ORCID: https://orcid.org/0000-0001-9305-6967)
- Pirkko Lepola (ORCID: https://orcid.org/0000-0001-9663-0872)
- Michiyo Sakiyama
- Sato Junko
- Laura Pioppo
- M. Turner (ORCID: https://orcid.org/0000-0002-5299-8656)
- Sarah Zaidi
- Ágnes Klein
- Breanne Stewart
- Albert J. Allen
- Robyn Langham
Institutions
- Health Canada (CA)
- European Medicines Agency (NL)
- United States Food and Drug Administration (US)
- University of Helsinki (FI)
- University of Liverpool (GB)
- Duke University (US)
- Helsinki University Hospital (FI)
- Australian Government (AU)
- Critical Path Institute (US)
- University Hospital Southampton NHS Foundation Trust (GB)
- Department of Health and Aged Care (AU)
- Clinical Research Institute (US)
- Royal Aberdeen Children's Hospital (GB)
- NIHR Southampton Biomedical Research Centre (GB)
- National Center For Child Health and Development (JP)
- Go4children (NL)
- Murdoch Children's Research Institute (AU)
- University of Southampton (GB)
- Pharmaceuticals and Medical Devices Agency (JP)
Publication Details
- Journal
- Frontiers in Medicine
- Published
- 2025-04-15
- DOI
- https://doi.org/10.3389/fmed.2025.1542408
- Citations
- 1
- Primary Topic
- Pharmaceutical studies and practices
- Type
- article
- Field-Weighted Citation Impact
- 3.49
Funders
- U.S. Department of Health and Human Services
- Genome Canada
- Canadian Institutes of Health Research