Leveraging a global, rederated, real-world data network to optimize investigator-initiated pediatric clinical trials: The TriNetX Pediatric Collaboratory Network

Clinical research networks facilitate collaborative research, but data-sharing remains a common barrier. The**** TriNetX platform provides real-time access to electronic health record-derived, anonymized data from 173 healthcare organizations (HCOs) and tools for queries and analysis. In 2022, four pediatric HCOs worked with TriNetX leadership to found the Pediatric Collaboratory Network (PCN), facilitated via a multi-institutional data use agreement (DUA). The DUA enables collaborative study design and execution, with institutional review board (IRB)-approved transfer of complete datasets for further analyses on a per-protocol basis. Of the 41.2 million children with TriNetX records, the PCN represents nearly 10%. The PCN assisted several early-career investigators in bringing study concepts from conception to an international scientific meeting presentation and journal submission. The PCN facilitates EHR vendor-agnostic multicenter pediatric research on the global TriNetX platform. Co..., TriNetX platform: The TriNetX platform is a global, federated network where users can access continuously updated, anonymized electronic health records (EHR) data, including demographics, encounters, diagnoses, procedures, medications, laboratory values, vitals, and genomics. TriNetX provides sites with mapping to their common data model, which reduces onboarding burden. Compared to other popular data models such as i2b2 or OMOP, HCOs with limited IT and data resources benefit from the data harmonization and TriNetX’s EHR-agnostic infrastructure, which allows secure access to information shared from their data warehouses and EHRs. The TriNetX platform includes self-service tools that allow patient data to be aggregated and queried based on the inclusion/exclusion criteria for a given research project. Users can perform cohort comparison and analysis across clinical profiles and longitudinal measures. Publications drawing on TriNetX have demonstrated utility in answering research questio..., , # Leveraging a global, rederated, real-world data network to optimize investigator-initiated pediatric clinical trials: The TriNetX Pediatric Collaboratory Network

[https://doi.org/10.5061/dryad.dncjsxm81](https://doi.org/10.5061/dryad.dncjsxm81)

## Description of the data and file structure

This paper describes the creation of a networked collaboratory environment, and no new data were generated or analyzed in support of this research. Table 1 represents an overview of the salient standards used in the TriNetX Pediatric Collaboratory Network, including associated sources and quantity of clinical observations (as of June 15th, 2023). Figure 1 is designed to depict the geographical location of PCN founding members. Figure 2 depicts the number of patients in the network at PCN member healthcare organizations  (as of June 15th, 2023). Figure 3 represents the investigator’s path of inquiry to inform the development of a clinical trial and the utility of TriNetX during specific stages of ...,