Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network
The efficiency, quality, and scalability of clinical trial support services are essential for the success of multinational clinical trials particularly trials that recruit babies, children, and young people. Through a public private partnership funded by the Innovative Medicines Initiative 2 between...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Frontiers Media S.A.
2025-06-01
|
| Series: | Frontiers in Medicine |
| Subjects: | |
| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2025.1531276/full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849337534780276736 |
|---|---|
| author | Sabah Attar Sabah Attar Francisca P. Figueiras Francisca P. Figueiras Carla Peacock Hazel Wohlfahrt Birgitta C. P. Hüsken Susan Andrews Pirkko Lepola Margaret Patton Regis Hankard Eren Halil Fernando Pontes Soares Lionel K. Tan Ricardo M. Fernandes Ricardo M. Fernandes Mark A. Turner Mark A. Turner |
| author_facet | Sabah Attar Sabah Attar Francisca P. Figueiras Francisca P. Figueiras Carla Peacock Hazel Wohlfahrt Birgitta C. P. Hüsken Susan Andrews Pirkko Lepola Margaret Patton Regis Hankard Eren Halil Fernando Pontes Soares Lionel K. Tan Ricardo M. Fernandes Ricardo M. Fernandes Mark A. Turner Mark A. Turner |
| author_sort | Sabah Attar |
| collection | DOAJ |
| description | The efficiency, quality, and scalability of clinical trial support services are essential for the success of multinational clinical trials particularly trials that recruit babies, children, and young people. Through a public private partnership funded by the Innovative Medicines Initiative 2 between 2018 and 2025 involving 10 large originator pharmaceutical companies and 33 academic and third sector organizations, the conect4children (c4c) network has developed high-quality trial support services to promote consistent delivery in pediatric trials in over 220 sites across 21 countries, addressing gaps in communication, site identification, feasibility, and trial support. This paper explores the development and implementation of these services, using the Technology Readiness Levels (TRLs) and Service Readiness Levels (SRLs) frameworks to measure service progression and operational maturity. The initiative successfully streamlined targeted aspects of trial support. Over 6 years the multinational coordination of pediatric trials moved from SRL1 to SRL8 and services have been deployed in a sustainable non-profit organization. Challenges encountered include variability in site readiness for clinical trials and processes. Differences between companies in methodologies for collecting data about trial setup prevented clear understanding of the benefits of the c4c approach. Sustainability of long-term infrastructure beyond IMI2 funding will be managed by a new, independent, non-profit organization, conect4children Stichting based on scale up of services provided to industry and academia. The findings provide generalizable insights and lessons applicable to other research networks seeking to build or improve similar infrastructures. |
| format | Article |
| id | doaj-art-4889b4270c0e4ece8bad73bb6057a35c |
| institution | Kabale University |
| issn | 2296-858X |
| language | English |
| publishDate | 2025-06-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj-art-4889b4270c0e4ece8bad73bb6057a35c2025-08-20T03:44:39ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2025-06-011210.3389/fmed.2025.15312761531276Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) networkSabah Attar0Sabah Attar1Francisca P. Figueiras2Francisca P. Figueiras3Carla Peacock4Hazel Wohlfahrt5Birgitta C. P. Hüsken6Susan Andrews7Pirkko Lepola8Margaret Patton9Regis Hankard10Eren Halil11Fernando Pontes Soares12Lionel K. Tan13Ricardo M. Fernandes14Ricardo M. Fernandes15Mark A. Turner16Mark A. Turner17Department of Women’s and Children’s Health, Liverpool Women’s NHS Foundation Trust, University of Liverpool, Liverpool, United Kingdomconect4children Stichting, Utrecht, NetherlandsAssociation for Research and Development of Faculty of Medicine, Academic Consulting Research Organization, CETERA, Stand4kids, Lisbon, PortugalLaboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon, PortugalDepartment of Women’s and Children’s Health, Liverpool Women’s NHS Foundation Trust, University of Liverpool, Liverpool, United KingdomDepartment of Women’s and Children’s Health, Liverpool Women’s NHS Foundation Trust, University of Liverpool, Liverpool, United KingdomJohnson & Johnson, Breda, NetherlandsMPH, GSK, Durham, NC, United StatesHUS Helsinki University Hospital and University of Helsinki, Helsinki, FinlandNovartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ, United StatesPEDSTART, CHU Orléans, INSERM, F-45000, Orléans, France0Johnson & Johnson, High Wycombe, United Kingdom1IRIS-Servier, Gif-sur-Yvette, France2ViiV Healthcare, GSK HQ, London, United Kingdomconect4children Stichting, Utrecht, NetherlandsLaboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Lisbon, PortugalDepartment of Women’s and Children’s Health, Liverpool Women’s NHS Foundation Trust, University of Liverpool, Liverpool, United Kingdomconect4children Stichting, Utrecht, NetherlandsThe efficiency, quality, and scalability of clinical trial support services are essential for the success of multinational clinical trials particularly trials that recruit babies, children, and young people. Through a public private partnership funded by the Innovative Medicines Initiative 2 between 2018 and 2025 involving 10 large originator pharmaceutical companies and 33 academic and third sector organizations, the conect4children (c4c) network has developed high-quality trial support services to promote consistent delivery in pediatric trials in over 220 sites across 21 countries, addressing gaps in communication, site identification, feasibility, and trial support. This paper explores the development and implementation of these services, using the Technology Readiness Levels (TRLs) and Service Readiness Levels (SRLs) frameworks to measure service progression and operational maturity. The initiative successfully streamlined targeted aspects of trial support. Over 6 years the multinational coordination of pediatric trials moved from SRL1 to SRL8 and services have been deployed in a sustainable non-profit organization. Challenges encountered include variability in site readiness for clinical trials and processes. Differences between companies in methodologies for collecting data about trial setup prevented clear understanding of the benefits of the c4c approach. Sustainability of long-term infrastructure beyond IMI2 funding will be managed by a new, independent, non-profit organization, conect4children Stichting based on scale up of services provided to industry and academia. The findings provide generalizable insights and lessons applicable to other research networks seeking to build or improve similar infrastructures.https://www.frontiersin.org/articles/10.3389/fmed.2025.1531276/fullpediatric drug developmentclinical trialstrial servicesperformance managementfeasibilitysite identification |
| spellingShingle | Sabah Attar Sabah Attar Francisca P. Figueiras Francisca P. Figueiras Carla Peacock Hazel Wohlfahrt Birgitta C. P. Hüsken Susan Andrews Pirkko Lepola Margaret Patton Regis Hankard Eren Halil Fernando Pontes Soares Lionel K. Tan Ricardo M. Fernandes Ricardo M. Fernandes Mark A. Turner Mark A. Turner Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network Frontiers in Medicine pediatric drug development clinical trials trial services performance management feasibility site identification |
| title | Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network |
| title_full | Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network |
| title_fullStr | Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network |
| title_full_unstemmed | Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network |
| title_short | Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in Europe: insights from the conect4children (c4c) network |
| title_sort | developing and streamlining clinical trial services to support pediatric drug development across 21 countries in europe insights from the conect4children c4c network |
| topic | pediatric drug development clinical trials trial services performance management feasibility site identification |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2025.1531276/full |
| work_keys_str_mv | AT sabahattar developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT sabahattar developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT franciscapfigueiras developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT franciscapfigueiras developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT carlapeacock developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT hazelwohlfahrt developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT birgittacphusken developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT susanandrews developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT pirkkolepola developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT margaretpatton developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT regishankard developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT erenhalil developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT fernandopontessoares developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT lionelktan developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT ricardomfernandes developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT ricardomfernandes developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT markaturner developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork AT markaturner developingandstreamliningclinicaltrialservicestosupportpediatricdrugdevelopmentacross21countriesineuropeinsightsfromtheconect4childrenc4cnetwork |