The c4c Consortium is working to create the infrastructures, processes, and relationships that will allow the network to optimise the delivery of clinical trials in children and become self-sustainable beyond the duration of the IMI2 funding.
The work is organized in eight work packages, each of them responsible for specific aspects of c4c processes. These are the main duties of each working group:
Work Package 1 on “Project management and oversight of IMI project” is in charge of coordinating and overseeing all activities conducted by other work packages, to ensure adherence to the Consortium Agreement subscribed by all the beneficiaries, timelines, quality, and budget. Work Package 1 is led by the Project Leadership Team (PLT), constituted by the four Project Leads governing the overall project progress. The other project governance bodies are:
- The General Assembly (GA), constituted by representatives of all the beneficiaries. The GA is the ultimate decision-making body on overall strategy and composition of the consortium;
- The Project Steering Committee (PSC), constituted by all Work Package Leads. The PSC is the decision-making body on operational aspects of the project.
The PLT is supported operationally by the Project Management Office (PMO) which takes care of the day-to-day operational aspects.
Work Package 2 on “Organization and governance of the pan-EU paediatric clinical trials network” is responsible for generating the network governance procedures. Its work is closely linked to the Work Package 7 which oversees the implementation of these procedures.
Work Package 3 on “Business plans development, expansion of the network, and sustainability of the network sources of funding after IMI2 support”, has to develop the business strategy and model that will allow the network to self-sustain beyond the duration of the c4c funding by the European Commission. As the end of the project approaches, Work Package 3 will implement the start-up plan to start the network’s commercial operations.
Work Package 4 on “Scientific advice, feasibility, and innovation” aims to create the processes to provide the network’s clients with advice on several aspects of paediatric drug development, including experts’ opinions on particular diseases and study design, patients/parents representative groups which will ensure the patient-centred approach in the advice given, and innovative methodology experts to assist in developing new ways to overcome the hurdles of children’s drug development.
Work Package 5 on “Data coordinating centre and data quality standard” represents the information technology structure of the entire c4c consortium. The main objective of this group is to create systems, tools, and standards to enhance quality, utility, reusability, and uniformity of the data collected during the paediatric clinical trials.
Work Package 6 on “Network research personnel education and training” creates an integrated program of courses to ensure consistent scientific background of the network’s site staff, and effective trainings on procedures and policies, e.g. Good Clinical Practice, required to conduct paediatric clinical trials. The activities of Work Package 6 are supported by an Education Board (EB), composed of experts in the field of paediatric medicine, methodology, and education techniques.
Work Package 7 on “Planning and execution of clinical trials” works in close connection with Work Package 2, implementing processes and tools created by that work package, testing them in the proof-of-viability trials, and refining them based on their experiences before the end of the c4c project.
Work Package 8 on “Communication, dissemination, exploitation, and impact assessment” constitutes the frontline with the external environments to c4c which includes paediatric scientific communities and healthcare professionals, and the general population. Its duty is to ensure consistency and quality of the information spread outside with the support of a Communication and Dissemination Board (CDB), and to raise awareness on c4c, its objectives, and of paediatric drug research in general.