Mapping of Data-Sharing Repositories for Paediatric Clinical Research—A Rapid Review

Abstract

The reuse of paediatric individual patient data (IPD) from clinical trials (CTs) is essential to overcome specific ethical, regulatory, methodological, and economic issues that hinder the progress of paediatric research. Sharing data through repositories enables the aggregation and dissemination of clinical information, fosters collaboration between researchers, and promotes transparency. This work aims to identify and describe existing data-sharing repositories (DSRs) developed to store, share, and reuse paediatric IPD from CTs. A rapid review of platforms providing access to electronic DSRs was conducted. A two-stage process was used to characterize DSRs: a first step of identification, followed by a second step of analysis using a set of eight purpose-built indicators. From an initial set of forty-five publicly available DSRs, twenty-one DSRs were identified as meeting the eligibility criteria. Only two DSRs were found to be totally focused on the paediatric population. Despite an increased awareness of the importance of data sharing, the results of this study show that paediatrics remains an area in which targeted efforts are still needed. Promoting initiatives to raise awareness of these DSRs and creating ad hoc measures and common standards for the sharing of paediatric CT data could help to bridge this gap in paediatric research.

Development of the CDISC Pediatrics User Guide: a CDISC and conect4children collaboration

“…Due to the lack of paediatric specificity of CDISC standards, it is difficult for any organization to fully adopt CDISC standards when conducting paediatric clinical studies (12)(13)(14). This leads to institutions developing proprietary in-house data standards that cannot be shared outside the institutions and, in turn, prevents interoperability of acquired data.…”