“The conect4children (c4c) Consortium: Potential for Improving European Clinical Research into Medicines for Children” has been published in Pharmaceutical Medicine.
Clinical trial scientists and their teams, for several decades, have partially succeeded in improving ways on how paediatric trials are conducted. In 2007, the European Union recognised the need to facilitate development of medicines by implementing the Paediatric Regulation. In 2017, the 10-year review of the Paediatric Regulation identified barriers to the conduct of clinical trials, including delays in setting up and completing paediatric trials.
This review from c4c describes c4c’s role in addressing selected difficulties with designing and conducting paediatric clinical trials in Europe. Some of the key aspects that c4c provides are:
- expert advice input on study or protocol design and/or paediatric development programmes (including patient involvement activities)
- following a network of sites through harmonious procedures coordinated by national hubs (NH) and a single point of contact (SPoC) for Europe
- a facility for education and training for sites and trial teams
- support for managing data used by the c4c network and a common paediatric data dictionary.
c4c is enabled through a public-private partnership with Innovative Medicines Initiative (IMI). One of the key goals, after the IMI funding, is a seamless transfer of the c4c network into a sustainable independent legal entity. Already, c4c is piloting its network with a small number of studies, but this will be scaled up when a successor organisation is established post IMI funding.
To read more about c4c and its approach click here