Data Standardization within Pediatrics: BPCRN’s analysis of trials identifying cross-cutting data points

Abstract

Background/Aims: The conect4children (c4c) consortium, funded by Innovative Medicines Initiative (IMI2), was created in 2018 consisting of 20 national networks within Europe to facilitate and optimize clinical trials in children. One of the main aims of c4c is to improve standardization and reusability of trial data. A partnership was formed between c4c and the Clinical Data Interchange Standards Consortium (CDISC) to develop a novel Pediatric User Guide (PUG), involving a standardized definition of each cross-cutting pediatric-specific data point which is routinely collected in clinical trials. Method: A pediatric resident, a data manager and clinical research coordinator (CRC) of a university site were involved from the Belgian Paediatric Clinical Research Network. A review of the clinical trials performed between 2018 and December 2020 collected recurring pediatric-specific data points. More than 20 meetings were held to discuss these findings and identify priorities for standardized definition and inclusion in a paediatric data standard. For the review of the first selection of harmonized definitions, the national hub shared the call for experts with 15 sites. Two experienced sub-specialized experts reviewed the collected cross-cutting pediatric harmonized definitions. Results: For the first phase of harmonized definitions, within SPD-D.R.U.G. (clinical trial unit in Ghent University Hospital) around 51 trials were reviewed and over 35 cross-cutting data definitions were added. The pediatric resident added additional 5 suggestions and prioritization of clinical practice based on the experience of over 10 clinical trials. In the second phase, the two experts from Ghent University hospital reviewed the subset of harmonized definitions for priorities in the final inclusion. Conclusion: Clinical Trial Unit and national expertise requests in the development as well as translation of a paediatric data standard within an academic clinical setting is beneficial in the development of clinically realistic data standards