Background: Currently, clinical data from adult patients are collected in a systematic manner using accepted data standards. The recent changes in the legislation requires the generation of data to support the evidence of efficacy and safety of medicines used in children. In contrast to adults, a standardised process is lacking, which makes data collection and re-use rather inefficient, and consequently preventing or slowing down data integration for further clinical research and drug development. This project is part of the activities of a larger initiative under the auspices of the European Union, namely the European Paediatric Translational Research Infrastructure (EPTRI: https://eptri.eu/).
Objectives: The aim of the project is to evaluate the relevance of the BRIDG data model as basis for aggregation/integration of data from clinical trial and epidemiological research in children.
Methods: Published literature and case studies will be used to define a proposal (feasibility assessment)
Skills and competencies: In addition to data management, programming and data visualisation skills, basic knowledge in (bio) statistics and pharmacology will be required for the successful implementation of the project. Different tools and software programs will be be used during the project, including R.