The current European paediatric medicines development environment is fragmented, redundant and inefficient in terms of cost and time. Overcoming these barriers is one of the greatest challenges but also a huge opportunity for success for this project. c4c remains unique in aiming to overcome these obstacles by establishing trial-ready infrastructure, operational excellence and consolidated interaction and communication at European, national and site level.
c4c aims to positively impact the number of new, innovative medicines developed and ultimately accessible to children by increasing the number of qualified clinical sites that work in a coordinated way to manage Paediatric clinical trials efficiently and at high standard. With the inclusion and training of about 240 clinical sites from 21 European countries, c4c has already created a novel degree of coordination that is independent of specific projects and individual Sponsors. To further improve harmonization of site coordination across countries and quality of site operations, c4c has developed site standards and plans to pilot roll out to some sites. The SPoC and its links to national points of contact are ready to improve coordinated access to sites. Furthermore, driven by the feasibility requests related to the I-PoV studies, c4c is working together with speciality networks to find more capable sites and expand the c4c site database. To extend reach beyond Europe, c4c puts efforts into discussing possible ways to cooperate with clinical trial networks in other jurisdictions, having signed two-sided CDAs with two US and Canadian networks. c4c has started preliminary discussions with the European Joint Programme on Rare Diseases (EJP RD).
With close cooperation with the NHs, c4c has further refined a comprehensive set of network processes, SOPs and governance/quality documents to allow a network-wide, coordinated way to support set-up and conduct of clinical studies in all NHs and related sites. These processes, together with the standardized trainings modules generated and already rolled out to NHs and sites, led already to increased efficiency in the set-up of c4c-supported clinical studies.
A key aim is to promote the use of innovative methods in trial design and study planning by ensuring that the impact of patient/parents and clinical/methodological experts will increase. c4c has provided advice to additional studies from different specialties and from patients and parents to an increasing number of industry Beneficiaries, who have used this advice to improve study design and processes, and to support generation of regulatory documents and procedures. To further strengthen the input of young people and patients in the design of clinical studies, c4c PPI organized a session to test the “patient journey” related to one of the industry studies. c4c is currently in the process to recruit further interested young people and patients and parents to join the c4c Patient Involvement Expert database and to provide input to research proposals and/or study designs. All non-confidential deliverables are available on the c4c and CORDIS website.
