The conduct of clinical trials in paediatrics is essential to improve drug therapy in children. In Europe, paediatric clinical trials have been supported by the European Paediatric Regulation since 2007, but there is still a great need for high-quality clinical trials. The personnel and time required to conduct clinical trials in accordance with EU Regulations…
c4c are delighted to announce a new publication about Disease-specific data standardization. Standardization of disease-specific paediatric clinical trial data is a hugely challenging task. c4c brought together representatives from large initiatives, major data standards, well-known data dictionaries, patient registries, and clinical trial repositories with provisions for clinical data, to build a collaborative action plan for…
Rare Disease Day took place on the 29th February to raise awareness of rare diseases and demonstrate the solidarity amongst this unique global community. The day includes a global ‘Chain of Lights’ to illuminate buildings and landmarks in the rare disease colours. Many c4c beneficiaries took part in rare disease day events.
Increasingly researchers are asked by funders and ethics committees to provide a Patient and Public Involvement (PPI) plan and to demonstrate they have considered the perspectives of the patients and families they wish to recruit to their clinical trials and research. The European Young Persons Advisory Group Network (eYPAGnet) can provide support in both the design and delivery of the Patient and Public Involvement Plan for any research involving babies, children and young people.
Between the 19th -20th February, c4c partners brought together a number of representatives from different data infrastructures to align together in a workshop in Amsterdam to discuss how the needs of paediatric patients can be represented in the European Health Data space.
INCiPiT is the Italian Network for Paediatric Clinical Trials, which acts as a c4c National Hub (NH) in Italy.
Psychopharmacological treatment is an important component of the multimodal intervention approach to treating mental health conditions in children and adolescents. Currently, there are many unmet needs but also opportunities, alongside possible risks to consider, regarding the pharmacological treatment of mental health conditions in children and adolescents. In this Position Paper, we highlight and address these…