c4c is a success. During 2021 c4c actions have influenced other organizations and shown why c4c is important. Despite many difficulties, c4c is very effective because of the dedication by everyone who works on c4c. The hard work and dedication are paying off as we follow the c4c vision and mission.
The impacts made by c4c already are the basis for the sustainability of our work after the end of the IMI2 funding.
The strategic feasibility advice workstream has received 30 requests to date. The expert advice provided has been used by Sponsors to modify their plans internally. Some of the reports by c4c have been submitted to the Paediatric Committee at the European Medicines Agency (EMA).
A multi-stakeholder meeting (MSM) has been held in inflammatory bowel disease showing that the MSM concept can be extended beyond the fields of Oncology and neuromuscular disorders.
The National Hubs (NHs) have completed a series of efficient implementations of the c4c Confidentiality Disclosure Agreement (CDA). This work has speeded up the process for site identification. The c4c NHs have increased the number of sites that Sponsors are aware of by 10 – 30%. This has helped Sponsors develop a comprehensive view of paediatric sites.
c4c has developed a cross-cutting paediatric data dictionary with the leading data standards organization for the pharmaceutical industry, CDISC.
Multiple short training courses have been implemented and a year-long Advanced Course in Paediatric Clinical Trials and Drug Development has opened for c4c beneficiaries. The c4c Academy has 1325 users.
Patient and public involvement has been included in relevant parts of this work including responses to strategic feasibility advice requests and the design, planning, and conduct of the proof-of-viability trials.
The pathway to sustainability is supported by dissemination and communication. Extensive work to plan the organization that continues the work of c4c has been done and will be developed. Discussions about how the new organization will work are advancing well.
c4c has an excellent reputation because of timely responses, high-quality communication within the consortium and the prompt submission of strong Deliverables.
2021 has been a very difficult year for everybody, despite this c4c has made big steps forward. The progress with impact and sustainability made by c4c is a result of hard work by many people. Let’s continue to build the future together!
