DOI: 10.5061/dryad.dncjsxm81
title: Leveraging a global, rederated, real-world data network to optimize investigator-initiated pediatric clinical trials: The TriNetX Pediatric Collaboratory Network

description: 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. Continued growth of the PCN will advance
 knowledge in pediatric health.
description: <strong>TriNetX platform:</strong> 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 questions and
 gaining access to representative cohorts across diverse care
 settings. <strong>PCN framework and
 infrastructure:</strong> The PCN, founded in 2022, permits federated
 pediatric queries across sites in TriNetX to facilitate collaboration
 between investigators and subject-matter experts with similar interests.
 As active contributors to the network, each PCN member applies a
 data-driven approach to their work, repurposing EHR data for clinical
 investigation. Although aggregated data from member sites is visible in
 the TriNetX Global Health Research Network, the “added value” of the PCN
 master data-use agreement (DUA) is to improve collaborations by making it
 simpler for investigators to meet experts at other PCN member sites. The
 PCN is visible in the global TriNetX portal as a selectable network, and
 results are returned immediately with patient counts and abundant clinical
 data for each participating site (Figure 2; Table 1). A key feature is
 that no additional IRB reviews are needed to participate in or query the
 PCN. However, if a specific collaboration requires the collection and
 sharing of additional data not already provided to TriNetX, IRB approval
 or a letter of exemption is necessary. A steering committee of
 institutionally designated representatives, including biostatistics
 experts, from the four core sites and two TriNetX representatives, meets
 monthly to discuss data governance, coordination efforts, and new site
 engagement. To mitigate barriers to entry, the steering committee designed
 the membership process to be inclusive while ensuring that the structure
 and underlying mission of the PCN are maintained. Steering committee
 members can invite junior faculty to present research concepts and ongoing
 work that could benefit from PCN participation and PCN-based analyses.
 Investigators working under the master DUA can obtain aggregated counts at
 each of the PCN sites and ask the established point of contact at PCN
 sites for introductions to potential collaborators or learn how to share
 additional information unavailable through TriNetX. This might include,
 subject to IRB approval, obtaining de-identified data or validation of
 data at participating sites.
 <strong>RESULTS</strong> By
 relying on the Common Data Model provided by TriNetX, PCN members can
 focus their efforts on data exploration and collaboration. One clear
 advantage is that early-career investigators can design and execute
 single-center and multicenter data queries and out-of-the-box analytics in
 support of their research aims with little to no investment (e.g.,
 research funding, personnel) [Figure 3]. While members of the TriNetX
 Global Health Research Network can execute queries across the entire
 network, the community created by the PCN—which shares a common interest
 in pediatric research to learn from each other’s experiences and
 recommendations—may be of greatest utility. The PCN provides a
 consultative forum in which junior investigators can optimize the design
 of their queries and analytic approaches, as well as obtain guidance in
 preparing IRB protocols where warranted.
description: # 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 the research development lifecycle. ### Files and variables Table 1 - PCN_Table_1.pdf\ Table 1 - PCN_Table_1.csv (PCN_Table_1.pdf in CSV format) Figure 1 - PCN_Fig1.png Figure 2 - PCN_Fig2.png Figure 3 - PCN_Fig3.png ## Code/software This paper describes the creation of a networked collaboratory environment, and no new data were generated or analyzed in support of this research. Access to the TriNetX environment is available from [https://trinetx.com](https://trinetx.com). ## Access information Other publicly accessible locations of the data: * Not Applicable Data was derived from the following sources: * This paper describes the creation of a networked collaboratory environment, and no new data were generated or analyzed in support of this research. Access to the TriNetX environment is available from [https://trinetx.com](https://trinetx.com).