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Published on: March 20, 2021
Developing and streamlining clinical trial services to support pediatric drug development across 21 countries in
Sabah Attar1,2, Francisca P Figueiras3,4, Carla Peacock1
1Department of Women's and Children's Health, Liverpool Women's NHS Foundation Trust, University of Liverpool, Liverpool, United Kingdom.
Insights
The conect4children network developed high-quality pediatric clinical trial support services across 21 countries. This initiative improved multinational pediatric trial coordination and established a sustainable non-profit organization for future infrastructure.
Area of Science:
- Clinical pharmacology and pediatric research.
- Public-private partnerships in healthcare innovation.
Background:
- Multinational clinical trials, especially in pediatrics, require efficient, high-quality, and scalable support services.
- Gaps in communication, site identification, feasibility, and trial support hinder pediatric trial success.
Purpose of the Study:
- To explore the development and implementation of high-quality trial support services within the conect4children (c4c) network.
- To measure the progression and operational maturity of these services using Technology Readiness Levels (TRLs) and Service Readiness Levels (SRLs).
Main Methods:
- A public-private partnership (Innovative Medicines Initiative 2) involving pharmaceutical companies, academic, and third-sector organizations.
- Development and deployment of standardized trial support services across 220+ sites in 21 countries.
- Utilizing TRLs and SRLs frameworks to assess service development and operational maturity.
Main Results:
- The c4c network successfully developed and implemented high-quality trial support services, moving from SRL1 to SRL8 over six years.
- Streamlined targeted aspects of trial support, enhancing multinational pediatric trial coordination.
- Established a sustainable non-profit organization (conect4children Stichting) for long-term infrastructure.
Conclusions:
- The c4c initiative provides a scalable model for improving pediatric clinical trial support services globally.
- Lessons learned regarding site readiness variability and data collection methodologies offer generalizable insights for research networks.
- The establishment of a sustainable non-profit organization ensures the long-term viability of the developed infrastructure beyond initial funding.
Abstract:
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.
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