METHODS article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1531276
This article is part of the Research TopicPaediatric Drug DevelopmentView all 7 articles
Developing and Streamlining Clinical Trial Services to Support Paediatric Drug Development across 21 countries in Europe: Insights from the conect4children(c4c) Network
Provisionally accepted
Sabah Attar1,2*
Francisca P Figueiras3,4,5Carla Peacock1Hazel Wohlfahrt1
Biritta CP Hüsken6Susan Andrews7
Pirkko Lepola8Margaret Patton9Regis Hankard10Eren Halil11Fernando Pontes Soares12
Lionel Tan13
Ricardo M Fernandes2,3
Mark A. Turner1,2- 1University of Liverpool, Liverpool, United Kingdom
- 2conect4children Stichting, Utrecht, Netherlands, Netherlands
- 3University of Lisbon, Lisbon, Lisboa, Portugal
- 4Association for Research and Development of the Faculty of Medicine of the University of Lisbon (AIDFM), Lisboa, Portugal
- 5Stand4Kids, Lisbon, Portugal
- 6Johnson & Johnson (Germany), Neuss, Germany
- 7GlaxoSmithKline (United States), Philadelphia, Pennsylvania, United States
- 8Helsinki University Central Hospital, Helsinki, Uusimaa, Finland
- 9Novartis (United States), East Hanover, New Jersey, United States
- 10Institut National de la Santé et de la Recherche Médicale (INSERM), Paris, Île-de-France, France
- 11Johnson & Johnson, High Wycombe, England, United Kingdom
- 12Servier Paris-Saclay Research Institute, Institut de Recherche International Servier, Gif-sur-Yvette, Île-de-France, France
- 13GlaxoSmithKline (United Kingdom), Brentford, England, United Kingdom
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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 paediatric 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 paediatric 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 generalisable insights and lessons applicable to other research networks seeking to build or improve similar infrastructures.
Keywords: Paediatric drug development1, clinical trials2, trial services3, performance management4, Feasibility5, site identification6, technology readiness levels7, service readiness levels8
Received: 20 Nov 2024; Accepted: 12 May 2025.
Copyright: © 2025 Attar, Figueiras, Peacock, Wohlfahrt, Hüsken, Andrews, Lepola, Patton, Hankard, Halil, Soares, Tan, Fernandes and Turner. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Sabah Attar, University of Liverpool, Liverpool, United Kingdom
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.