The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children

Abstract

The need for information about new and existing drugs used in children was recognized in the European Union (EU) with the implementation of the Paediatric Regulation in 2007. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials. Across Europe, the difficulties with clinical research are compounded by variation within countries and between countries. Ethics and regulatory review have national specificities. This paper describes the Collaborative Network for European Clinical Trials for Children (conect4children, c4c), which addresses selected difficulties in the design and conduct of paediatric clinical trials. c4c is a time-limited public–private consortium funded by the Innovative Medicines Initiative (IMI2). The elements of c4c are as follows: expert advice providing input on study design and/or paediatric development programmes (including patient involvement activities); a network of sites following harmonised procedures coordinated by National Hubs and a single point of contact for Europe; a facility for education and training for sites and trial teams; and support for managing data used by the network and a common paediatric data dictionary. c4c does not sponsor trials. c4c is taking a phased approach with careful piloting through industry and non-industry studies intended to demonstrate the viability of the network (proof-of-viability studies). c4c uses a co-design approach involving industry and academics within a clearly defined scope. A sustainable, successor organization open to all potential service users will be open for business before the end of IMI2 funding in 2024.

Understanding paediatric data standards challenges through academia‐industry partnerships: A conect4children (c4c) qualitative study

“…A review article describing the c4c initiative, laid out nine adopting principles. 14 While detailed discussions on each of these nine principles are beyond the scope of this paper, we focus on two of the principles-academia-industry partnership and data interoperability. Collaboration between academia and industry has been viewed positively in several healthcare applications.…”

Clinical, methodology, and patient/carer expert advice in pediatric drug development by conect4children

“…across all disease areas, in all pediatric age groups and all phases of the clinical drug development process. 8 One focus of c4c is to promote innovative trial design to optimize pediatric development plans and protocols. This will be done through the provision of expert advice to sponsors, initially the c4c industry and academic beneficiaries, and, as of mid-2023, in the successor c4c legal entity, to any sponsor.…”

“…In the European Union, the conect4children (c4c) project is a public‐private partnership funded by the Innovative Medicines Initiative (IMI) to set up a sustainable, integrated pan‐European collaborative pediatric clinical trial network that will speed up and facilitate the running of high‐quality clinical trials in children, while ensuring that the voices of young patients and their families are heard 4,7 . The plan is to build the infrastructure and capacity to conduct multinational pediatric clinical trials across all disease areas, in all pediatric age groups and all phases of the clinical drug development process 8 …”

How Can a Clinical Data Modelling Tool Be Used to Represent Data Items of Relevance to Paediatric Clinical Trials? Learning from the Conect4children (c4c) Consortium

“…conect4children (c4c) is a six-year project established in 2018 and funded by the Innovative Medicines Initiative (IMI2) to address the multitude of barriers facing the development and delivery of effective paediatric clinical trials. This will include a trial feasibility, conducted through a single point of contact, expert advice, an educational academy for clinical trial personnel and data harmonisation services [1][2][3].…”