Over the course of the c4c project period, c4c has led initiatives aimed at standardising and harmonising data collection in paediatric clinical trials. Most recently we collaborated with the European Rare Disease Research Coordination and Support Action consortium (ERICA), which is dedicated to advancing the research activity of European Reference Networks (ERNs), to hold a joint workshop in Heidelberg between 4th- 5th February. The purpose of this workshop was to explore ways of enhancing the potential for ERN registries to support paediatric research. Many ERN registries have aspirations to fulfil roles such as supporting trial feasibility and recruitment and exploring how their data could be used as Real World Evidence – these are longer-term goals, but actions were identified to support some of these processes. Some immediate ‘next steps’ include better promotion of the current potential of the registries, continuing paediatric standardisation efforts (including within the European Health Data Space, building on c4c’s work here) and supporting the registries in embedding tools and approaches pioneered in other communities.
The beneficiaries delivering the c4c data harmonization and standardization work recognise the importance of collaborating with other organisations that are also working to improve the standardisation of data collected in paediatric clinical trials. By working together, we can better align our approach and avoid duplication of effort. This is why c4c created the Global Paediatric Data Forum (GLOPAD). In May 2022, c4c hosted a workshop to bring together international experts from academia, industry, data standards consortia, data repositories and large paediatric health networks to discuss existing resources that could aid in achieving standardization of paediatric disease specific data. At the end of the workshop, the GLOPAD was created as a forum to continue these discussions. It has grown since its inception and continues to meet quarterly online to raise awareness of the need to avoid siloing data and to optimally use and reuse data from vulnerable populations. More information about the workshop is available here. More information about the GLOPAD is available here.
c4c beneficiaries, through the PDIWG (Paediatric Data Interoperability Working Group), oversaw the development of a number of collaborations, tools and resources to standardize and harmonize paediatric clinical trial data:
- Development of the Cross Cutting Paediatric Data Dictionary (CCPDD) and two clinical modelling tool pilots.
- Collaboration with CDISC to develop the Pediatrics User Guide (PUG), the Pediatric User Network (CPUN) and upcoming pediatric training module.
- Collaboration with FAIRPlus to produce a recipe in the FAIR Cookbook.
- Workshop on Increasing the Harmonization and Standardization of Disease Specific Data and the Global Paediatric Data Forum (GLOPAD).
- Workshop on Engaging with the European Health Data Space (EHDS) resulting in a white paper and an editorial.
- Recommendations to leverage the potential of data sharing between paediatric clinical trials and EHRs will be published soon.
- 11 publications
