Evidence map›Paper›PMID 40303377›Full record

ArticleFrontiers in medicine2025

Requirements and special considerations for drug trials with children across six jurisdictions: 1. Clinical trial application review in the regulatory approval process.

Breanne Stewart, Pirkko Lepola, Gunter F Egger, Fahimeda Ali, Albert J Allen, Alysha K Croker, Andrew J Davidson, Pamela Dicks, Saul N Faust, Dionna Green and 14 more

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Frontiers in medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors.

Breanne StewartMaternal Infant Child and Youth Research Network (MICYRN), Vancouver, BC, Canada.
Pirkko LepolaDepartment of Children and Adolescents, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Gunter F EggerPediatric Medicine Office and Data Analytics and Methods Task Force, European Medicines Agency (EMA), Amsterdam, Netherlands.
Fahimeda Ali *Paediatrics-Innovative Medicines, Healthcare Quality & Access, MHRA, London, United Kingdom.
Albert J Allen *Institute for Advances Clinical Trials for Children, Rockville, MD, United States.
Alysha K Croker *Biologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch, Health Canada, Ottawa, ON, Canada.
Andrew J Davidson *Melbourne Children's Trials Centre, Murdoch Children's Research Institute, Melbourne, VIC, Australia.
Pamela Dicks *NHS Scottish Children's Research Network, Royal Aberdeen Children's Hospital, Aberdeen, United Kingdom.
Saul N Faust *NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom.
Dionna Green *Office of Pediatric Therapeutics, Office of the Commissioner, United States Food and Drug Administration, Silver Spring, MD, United States.
Collin Hovinga *Institute for Advances Clinical Trials for Children, Rockville, MD, United States.
Agnes V Klein *Biologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch, Health Canada, Ottawa, ON, Canada.
Robyn Langham *Therapeutic Goods Administration, Australian Government Department of Health and Aged Care, Canberra, ACT, Australia.
Hidefumi Nakamura *Department of Research and Development Supervision, National Centre for Child Health and Development, Tokyo, Japan.
Laura Pioppo *Pediatric Medicine Office and Data Analytics and Methods Task Force, European Medicines Agency (EMA), Amsterdam, Netherlands.
Shiva Ramroop *Paediatrics-Innovative Medicines, Healthcare Quality & Access, MHRA, London, United Kingdom.
Michiyo Sakiyama *Pediatric Drug Working Group, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Isabel Sanchez Vigil de la Villa *Pediatric Medicine Office and Data Analytics and Methods Task Force, European Medicines Agency (EMA), Amsterdam, Netherlands.
Junko Sato *Pediatric Drug Working Group, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan.
Donna L Snyder *WCG Clinical, Princeton, NJ, United States.
Mark A Turner *Department of Women's and Children's Health, University of Liverpool, Liverpool, United Kingdom.
Sarah Zaidi *Office of Pediatric Therapeutics, Office of the Commissioner, United States Food and Drug Administration, Silver Spring, MD, United States.
Kanecia Zimmerman *Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States.
Thierry Lacaze-MasmonteilMaternal Infant Child and Youth Research Network (MICYRN), Vancouver, BC, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: Conducting clinical trials (CTs) with children presents several challenges. A major challenge is the need to enrol participants at multiple sites across different jurisdictions. Regardless of whether the trials involve children, adults, or both, CTs need to meet separate Competent Authority (CA) requirements to proceed in each participating country. This work, undertaken by the Working Group (WG) on International Collaborations at the European Network of Pediatric Research at the European Medicines Agency (Enpr-EMA) aims to describe the regulatory requirements including any specific to pediatrics, as well as current or upcoming changes across six jurisdictions-the European Union (EU), United Kingdom (UK), United States of America (USA), Canada, Japan, and Australia. Methods: An open questionnaire developed by the WG and directed at both the CA and the national pediatric clinical trial networks arranged by jurisdictions. Results: A synopsis of the current legislative and regulatory requirements for CTs applications, application submission processes and application requirements is presented for each of the six jurisdictions. Requirements were found to be mostly consistent across jurisdictions. No difference was found in processes for CTs submission, review, and authorization for pediatric CTs vs. CTs in adults. However, there are additional Ethics Committee/Institutional Review Board requirements for clinical trials including children. Some jurisdictions are considering adopting a risk-based approach, inspired by the Organization of Economic Co-operation and Development (OECD) recommendations on Governance. Changes currently or soon to be implemented in some jurisdictions are also described. Conclusions: 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.

Indexed as

clinical trial applicationclinical trial authorizationclinical trialspediatricsregulatory sciencerisk-based approach

Identifiers

PMID40303377
PMCPMC12037545

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.