conect4children (c4c)* is a large, pan-European network, which aims to facilitate the development of new drugs and other therapies for the entire paediatric population. c4c is a public private partnership between industry, health care professionals, academia and patient representatives, who come together to develop the infrastructure and resources needed to support high quality paediatric clinical trials.

In order to test the infrastructure and resources developed within the c4c network, academic and industry proof of viability studies are being conducted. For more information about the studies, please click here

Based on our experience with the TREAT-NMD network, Newcastle University were invited to become a c4c partner and we are involved in the following aspects of the c4c network:

• Data coordinating centre and data quality standards: As work package leads, we are looking to identify and promote best practice to enhance the value of data collected in clinical trials and support the reuse of data where possible. The key output of this work is a cross-cutting paediatric data dictionary for use within the network. We have also collaborated with CDISC to develop the Pediatrics User Guide. The user guide focuses on cross-cutting clinical concepts related to paediatric research and describes how to use CDISC Standards to collect and structure data used in clinical trials. This was an important collaboration for us and c4c as CDISC standards are required for submission by the United States Food and Drug Administration (FDA) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA), recommended by the China National Medical Products Administration (NMPA) and adopted by the world’s leading research organisations. A collaboration with another IMI funded project, FAIRPlus resulted in a recipe ‘Creating a metadata profile for clinical trial protocols’ in the FAIR Cookbook. The recipe outlines steps to help make paediatric clinical trial metadata more FAIR (Findable, Accessible, Interoperable and Reusable). The Global Paediatric Data Forum (GLOPAD) has also been established as a result of the data harmonisation and standardisation work carried out within c4c.

• Training and education: We have supported the development of short training courses for clinical trial unit staff involved in the development of paediatric medicines. These courses have included topics such as innovative trial design, gene therapy, patient registries and facilitating remote and hybrid clinical trials. Our work has included supporting the sponsors of the c4c proof of viability studies to develop trial specific training courses including protocol training and trial specific procedures training.

• Expert advice: Prof. Volker Straub, director of the JWMDRC, was selected as the clinical lead of the neuromuscular c4c expert group. The aim of the expert groups is to provide advice needed to improve child health and paediatric medicine development through an effective network function.

• Communication and dissemination: We are involved in supporting the development of an informative campaign aimed at communicating the benefits of paediatric research to the general public, as well as producing communications to disseminate the work of the c4c network and leading on the project’s knowledge translation strategy.

For more information about the project, please contact project manager [email protected]

* This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777389.

The Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA.