Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process
BackgroundConducting 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...
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Frontiers Media S.A.
2025-02-01
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| author | Breanne Stewart Pirkko Lepola Gunter F. Egger Fahimeda Ali Albert J. Allen Albert J. Allen Alysha K. Croker Andrew J. Davidson Pamela Dicks Saul N. Faust Saul N. Faust Dionna Green Collin Hovinga Collin Hovinga Agnes V. Klein Robyn Langham Hidefumi Nakamura Laura Pioppo Shiva Ramroop Michiyo Sakiyama Isabel Sanchez Vigil de la Villa Junko Sato Donna L. Snyder Mark A. Turner Mark A. Turner Sarah Zaidi Kanecia Zimmerman Kanecia Zimmerman Thierry Lacaze-Masmonteil |
| author_facet | Breanne Stewart Pirkko Lepola Gunter F. Egger Fahimeda Ali Albert J. Allen Albert J. Allen Alysha K. Croker Andrew J. Davidson Pamela Dicks Saul N. Faust Saul N. Faust Dionna Green Collin Hovinga Collin Hovinga Agnes V. Klein Robyn Langham Hidefumi Nakamura Laura Pioppo Shiva Ramroop Michiyo Sakiyama Isabel Sanchez Vigil de la Villa Junko Sato Donna L. Snyder Mark A. Turner Mark A. Turner Sarah Zaidi Kanecia Zimmerman Kanecia Zimmerman Thierry Lacaze-Masmonteil |
| author_sort | Breanne Stewart |
| collection | DOAJ |
| description | BackgroundConducting 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.MethodsAn open questionnaire developed by the WG and directed at both the Competent Authorities (CA) and the national pediatric clinical trial networks arranged by jurisdictions.ResultsA 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.ConclusionThis 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. |
| format | Article |
| id | doaj-art-f0fb7c890fa243e9a0b5ce1197b5ea4b |
| institution | Kabale University |
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| language | English |
| publishDate | 2025-02-01 |
| publisher | Frontiers Media S.A. |
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| spelling | doaj-art-f0fb7c890fa243e9a0b5ce1197b5ea4b2025-02-11T06:59:09ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-02-011210.3389/fmed.2025.15397871539787Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval processBreanne Stewart0Pirkko Lepola1Gunter F. Egger2Fahimeda Ali3Albert J. Allen4Albert J. Allen5Alysha K. Croker6Andrew J. Davidson7Pamela Dicks8Saul N. Faust9Saul N. Faust10Dionna Green11Collin Hovinga12Collin Hovinga13Agnes V. Klein14Robyn Langham15Hidefumi Nakamura16Laura Pioppo17Shiva Ramroop18Michiyo Sakiyama19Isabel Sanchez Vigil de la Villa20Junko Sato21Donna L. Snyder22Mark A. Turner23Mark A. Turner24Sarah Zaidi25Kanecia Zimmerman26Kanecia Zimmerman27Thierry Lacaze-Masmonteil28Maternal Infant Child and Youth Research Network (MICYRN), Vancouver, BC, CanadaDepartment of Children and Adolescents, University of Helsinki and Helsinki University Hospital, Helsinki, FinlandPediatric Medicine Office and Data Analytics and Methods Task Force, European Medicines Agency (EMA), Amsterdam, NetherlandsPaediatrics – Innovative Medicines, Healthcare Quality & Access, MHRA, London, United KingdomInstitute for Advances Clinical Trials for Children, Rockville, MD, United StatesCritical Path Institute, Tucson, AZ, United StatesBiologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch, Health Canada, Ottawa, ON, CanadaMelbourne Children’s Trials Centre, Murdoch Children’s Research Institute, Melbourne, VIC, AustraliaNHS Scottish Children’s Research Network, Royal Aberdeen Children’s Hospital, Aberdeen, United Kingdom0NIHR Southampton Clinical Research Facility and Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom1Faculty of Medicine and Institute for Life Sciences, University of Southampton, Southampton, United Kingdom2Office of Pediatric Therapeutics, Office of the Commissioner, United States Food and Drug Administration, Silver Spring, MD, United StatesInstitute for Advances Clinical Trials for Children, Rockville, MD, United StatesCritical Path Institute, Tucson, AZ, United StatesBiologic and Radiopharmaceutical Drugs Directorate, Health Products and Food Branch, Health Canada, Ottawa, ON, Canada3Therapeutic Goods Administration, Australian Government Department of Health and Aged Care, Canberra, ACT, Australia4National Centre for Child Health and Development, Department of Research and Development Supervision, Tokyo, JapanPediatric Medicine Office and Data Analytics and Methods Task Force, European Medicines Agency (EMA), Amsterdam, NetherlandsPaediatrics – Innovative Medicines, Healthcare Quality & Access, MHRA, London, United Kingdom5Pediatric Drug Working Group, Pharmaceuticals and Medical Devices Agency, Tokyo, JapanPediatric Medicine Office and Data Analytics and Methods Task Force, European Medicines Agency (EMA), Amsterdam, Netherlands5Pediatric Drug Working Group, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan6WCG Clinical, Princeton, NJ, United States7Department of Women’s and Children’s Health, University of Liverpool, Liverpool, United Kingdom8conect4children Stichting, Utrecht, Netherlands2Office of Pediatric Therapeutics, Office of the Commissioner, United States Food and Drug Administration, Silver Spring, MD, United States9Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC, United States0Department of Pediatrics, Duke University School of Medicine, Durham, NC, United StatesMaternal Infant Child and Youth Research Network (MICYRN), Vancouver, BC, CanadaBackgroundConducting 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.MethodsAn open questionnaire developed by the WG and directed at both the Competent Authorities (CA) and the national pediatric clinical trial networks arranged by jurisdictions.ResultsA 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.ConclusionThis 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.https://www.frontiersin.org/articles/10.3389/fmed.2025.1539787/fullpediatricsclinical trialsregulatory scienceresearch ethics reviewresearch ethics committeeinstitutional review board |
| spellingShingle | Breanne Stewart Pirkko Lepola Gunter F. Egger Fahimeda Ali Albert J. Allen Albert J. Allen Alysha K. Croker Andrew J. Davidson Pamela Dicks Saul N. Faust Saul N. Faust Dionna Green Collin Hovinga Collin Hovinga Agnes V. Klein Robyn Langham Hidefumi Nakamura Laura Pioppo Shiva Ramroop Michiyo Sakiyama Isabel Sanchez Vigil de la Villa Junko Sato Donna L. Snyder Mark A. Turner Mark A. Turner Sarah Zaidi Kanecia Zimmerman Kanecia Zimmerman Thierry Lacaze-Masmonteil Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process Frontiers in Medicine pediatrics clinical trials regulatory science research ethics review research ethics committee institutional review board |
| title | Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process |
| title_full | Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process |
| title_fullStr | Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process |
| title_full_unstemmed | Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process |
| title_short | Requirements and special considerations for drug trials with children across six jurisdictions: 2. Ethics review in the regulatory approval process |
| title_sort | requirements and special considerations for drug trials with children across six jurisdictions 2 ethics review in the regulatory approval process |
| topic | pediatrics clinical trials regulatory science research ethics review research ethics committee institutional review board |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2025.1539787/full |
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