“Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines
Introduction: The Collaborative Network for European Clinical Trials for Children (c4c) is a public private partnership with a developed infrastructure across European sites to support the design and conduct of multi-national academic and industry paediatric clinical trials. This paper aims to revie...
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| Language: | English |
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Elsevier
2025-04-01
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| Series: | Contemporary Clinical Trials Communications |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S245186542500016X |
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| author | Sabah Attar Carla Peacock Mandy Wan Erin Halil Chloe Bickerstaff Lionel Tan Hafsah Bhatti Ricardo M. Fernandes Regis Hankard Mark A. Turner |
| author_facet | Sabah Attar Carla Peacock Mandy Wan Erin Halil Chloe Bickerstaff Lionel Tan Hafsah Bhatti Ricardo M. Fernandes Regis Hankard Mark A. Turner |
| author_sort | Sabah Attar |
| collection | DOAJ |
| description | Introduction: The Collaborative Network for European Clinical Trials for Children (c4c) is a public private partnership with a developed infrastructure across European sites to support the design and conduct of multi-national academic and industry paediatric clinical trials. This paper aims to review the learning points identified during co-development of c4c processes by academic and industry partners. Methods: Study metrics were recorded. Learning points were captured during network development, categorized and included in a thematic analysis from which lessons learnt were identified. Results: 12 trials were supported by sites coordinated at national level and integrated at European level. A total of 9 CDA cycles were completed, resulting in 436 site CDAs signed in a median of 8.11 days. Lessons learnt included the importance of: relationship building by early engagement with partners; reducing misunderstanding by clear communication; flexibility, adaptability and experiential learning which are required for service improvement. Practical actions that infrastructure developers and users can take include operational planning with a view to fostering collaborations across stakeholders, sharing information about different approaches to clinical operations, and raising awareness of the need for explicit work on collaboration, communication, and planning. Traditionally, these activities are repeated for each trial. The use of a persistent network allows the benefits of collaboration to be recycled. Discussion: Building a successful framework for collaboration allows dedication and determination to carry over from one study to another. The initial investment of time to share assumptions and “state the obvious” by each user will support future trials. |
| format | Article |
| id | doaj-art-876f25c94219498e912daf2530befad1 |
| institution | Kabale University |
| issn | 2451-8654 |
| language | English |
| publishDate | 2025-04-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Contemporary Clinical Trials Communications |
| spelling | doaj-art-876f25c94219498e912daf2530befad12025-02-09T05:00:43ZengElsevierContemporary Clinical Trials Communications2451-86542025-04-0144101442“Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicinesSabah Attar0Carla Peacock1Mandy Wan2Erin Halil3Chloe Bickerstaff4Lionel Tan5Hafsah Bhatti6Ricardo M. Fernandes7Regis Hankard8Mark A. Turner9University of Liverpool, Department of Women's and Children's Health, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, L8 7SS, UK; Conect4children Stichting, Utrecht, NetherlandsUniversity of Liverpool, Department of Women's and Children's Health, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, L8 7SS, UK; Corresponding author.Evelina Pharmacy, Guys' & St Thomas' NHS Foundation Trust, London, SE1 7EH, UK; Institute of Pharmaceutical Science, King's College London, London, SE1 9NH, UKJohnson & Johnson, 50-100 Holmers Farm Way, High Wycombe, HP12 4DP, UKUniversity of Liverpool, Department of Women's and Children's Health, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, L8 7SS, UKViiV Healthcare, 980 Great West Road Brentford, Middlesex, TW8 9GS, UKLeeds Beckett University, Leeds, LS1 3HE, England, UKConect4children Stichting, Utrecht, Netherlands; Laboratory of Clinical Pharmacology and Therapeutics, Faculty of Medicine, University of Lisbon, Av. Prof. Egas Moniz MB, 1649-028, Lisboa, PortugalFrench Clinical Research Infrastructure Network (F-CRIN)-PEDSTART, INSERM, University of Tours, University Hospital of Orléans, Orléans, FranceUniversity of Liverpool, Department of Women's and Children's Health, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, L8 7SS, UK; Conect4children Stichting, Utrecht, NetherlandsIntroduction: The Collaborative Network for European Clinical Trials for Children (c4c) is a public private partnership with a developed infrastructure across European sites to support the design and conduct of multi-national academic and industry paediatric clinical trials. This paper aims to review the learning points identified during co-development of c4c processes by academic and industry partners. Methods: Study metrics were recorded. Learning points were captured during network development, categorized and included in a thematic analysis from which lessons learnt were identified. Results: 12 trials were supported by sites coordinated at national level and integrated at European level. A total of 9 CDA cycles were completed, resulting in 436 site CDAs signed in a median of 8.11 days. Lessons learnt included the importance of: relationship building by early engagement with partners; reducing misunderstanding by clear communication; flexibility, adaptability and experiential learning which are required for service improvement. Practical actions that infrastructure developers and users can take include operational planning with a view to fostering collaborations across stakeholders, sharing information about different approaches to clinical operations, and raising awareness of the need for explicit work on collaboration, communication, and planning. Traditionally, these activities are repeated for each trial. The use of a persistent network allows the benefits of collaboration to be recycled. Discussion: Building a successful framework for collaboration allows dedication and determination to carry over from one study to another. The initial investment of time to share assumptions and “state the obvious” by each user will support future trials.http://www.sciencedirect.com/science/article/pii/S245186542500016XPaediatricsClinical networksNetwork developmentLessons learntCollaborationInfrastructure |
| spellingShingle | Sabah Attar Carla Peacock Mandy Wan Erin Halil Chloe Bickerstaff Lionel Tan Hafsah Bhatti Ricardo M. Fernandes Regis Hankard Mark A. Turner “Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines Contemporary Clinical Trials Communications Paediatrics Clinical networks Network development Lessons learnt Collaboration Infrastructure |
| title | “Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines |
| title_full | “Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines |
| title_fullStr | “Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines |
| title_full_unstemmed | “Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines |
| title_short | “Common sense is hard work” but benefits from persistent collaboration: Lessons learnt from the development of The Collaborative Network for European Clinical Trials for Children (c4c) to support the conduct of paediatric clinical trials of medicines |
| title_sort | common sense is hard work but benefits from persistent collaboration lessons learnt from the development of the collaborative network for european clinical trials for children c4c to support the conduct of paediatric clinical trials of medicines |
| topic | Paediatrics Clinical networks Network development Lessons learnt Collaboration Infrastructure |
| url | http://www.sciencedirect.com/science/article/pii/S245186542500016X |
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