Evidence map›Paper›PMID 40007583›Full record

ArticleFrontiers in medicine2025

Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics 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

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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. An erratum has been issued. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

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 *National Centre for Child Health and Development, Department of Research and Development Supervision, 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

FDA HHS U18 FD006297
6 · The paper itself

Abstract

Background: Conducting clinical drug trials (CTs) with children presents several challenges. A major challenge is the need to enroll participants at multiple sites across different jurisdictions. Recruiting the required number of children within a reasonable timeframe requires the study to be reviewed by Research Ethics Boards (REB) or Institutional Review Boards (IRB) at multiple sites across various jurisdictions. 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 research ethics review requirements including any pediatric specific requirements, 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 Competent Authorities (CA) and the national pediatric clinical trial networks arranged by jurisdictions. Results: A synopsis of the current regulatory requirements covers centralized versus independent review, comparisons between investigator initiated and industry sponsored clinical trials, timelines, review board members requirements and the consenting/assent process for clinical trial (CT) applications, application submission processes and application requirements for each of the six jurisdictions. It also describes changes currently or soon to be implemented in some jurisdictions. Conclusion: This environmental scan highlights the differences in ethics review for CTs in pediatric medicine development across six jurisdictions. While there is a growing trend for centralized ethics review, it is not universally permitted due to institutional, state/provincial, or national policies. Even where central review is allowed, local review may still be required for vulnerable populations like children. Harmonized and centralized ethics reviews offer advantages such as expert pediatric reviewers and efficient and consistent evaluations.

Indexed as

clinical trialsinstitutional review boardpediatricsregulatory scienceresearch ethics committeeresearch ethics review

Identifiers

PMID40007583
PMCPMC11850317

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.