Building blocks

“Better medicines for babies, children and young people” is the ambitious aim of c4c. To realize this goal the project must first develop a pan-European, paediatric clinical trial network, and provide a wealth of support, tools and resources to build the infrastructure to deliver more efficient and effective paediatric clinical trials.

The c4c consortium has selected its first portfolio of pan-European paediatric studies aimed at advancing the understanding of high priority medicines commonly used in babies, children and young people in Europe. These four inaugural academic led studies will also be used to test the effectiveness of the c4c network.

High quality training about paediatric clinical research is essential to achieve the aims of c4c, a variety of training courses will be delivered through the specialized c4c Training Academy.  The first course on Paediatric Good Clinical Practice training course has now been launched. This online course is available to the c4c network’s site staff and healthcare professionals involved in the c4c supported clinical trials. This is the first of a series of courses created to ensure consistent background knowledge of the network’s site staff and effective training on procedures and policies required to conduct high quality paediatric clinical trials. A further course will be launching this December to support the inclusion of children and young patients, and families in designing clinical research.

To avoid pitfalls in clinical trial design and to bring the best trials to patients, c4c has appointed approximately 300 experts to 24 Expert Groups (16 Clinical and 8 Innovative Methodology) to provide high quality advice on paediatric study design and paediatric medicine development strategy. Appropriate experts with relevant expertise will be selected from these groups to join ad-hoc Strategic Feasibility Advice meetings to give advice, on request, to EFPIA c4c partners on a paediatric study or program of studies. Young adult patients or parents will be selected from the c4c Patient and Public Involvement database to join the advice meetings, as appropriate. A call is ongoing for patients, caregivers, patients organizations and YPAGs, who are interested in joining this group of patients.  Since the set-up of the expert groups in April, the Secretariat has received four advice requests from c4c EFPIA partners and the first meeting took place in 23 October 2019.

Further information about current c4c activities and how c4c plans to achieve its ambitious aim can be found here.