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. 2024 Sep 2;7(3):ooae077.
doi: 10.1093/jamiaopen/ooae077. eCollection 2024 Oct.

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

Jurran L Wilson  1 , Marisol Betensky  2   3 , Sharda Udassi  4 , Pavithra R Ellison  5 , Richard Lilienthal  6 , Lindsay R Stahl  6 , Matvey B Palchuk  6 , Ayesha Zia  7 , Deborah A Town  8 , Wes Kimble  9 , Neil A Goldenberg  3   10 , Hiroki Morizono  11
Affiliations

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

Jurran L Wilson et al. JAMIA Open. .

Abstract

Objective: Clinical research networks facilitate collaborative research, but data sharing remains a common barrier.

Materials and methods: The TriNetX platform provides real-time access to electronic health record (EHR)-derived, anonymized data from 173 healthcare organizations (HCOs) and tools for queries and analysis. In 2022, 4 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-approved transfer of complete datasets for further analyses on a per-protocol basis.

Results and discussion: Of the 41.2 million children with TriNetX records, the PCN represents nearly 10%. The PCN assisted several early-career investigators to bring study concepts from conception to an international scientific meeting presentation and journal submission.

Conclusion: 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.

Keywords: electronic health record; pediatric; real-world data.

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Conflict of interest statement

A.Z. has received honoraria from Sanofi and Takeda for her role as an advisory board member for scientific advisory boards in the past 3 years. N.A.G. has received or has recently received consultancy fees from Anthos Therapeutics, Bayer, Boehringer-Ingelheim, Daiichi Sankyo, and the University of Colorado-affiliated Academic Research Organization CPC Clinical Research for roles in clinical trial planning or oversight committees (eg, advisory committee; steering committee; data and safety monitoring committee) in pharmaceutical industry-sponsored pediatric clinical trials of antithrombotics. All other authors have indicated they have no financial relationships or potential conflicts of interest relevant to this article to disclose.

Figures

Figure 1.
Figure 1.
Map of current PCN member healthcare organizations (HCO). Tan: Children’s National Hospital; Yellow: West Virginial University Medicine Children’s; Red: Children’s Health; Blue: Johns Hopkins All Children’s Hospital/Johns Hopkins Children’s Center.
Figure 2.
Figure 2.
Number of unique pediatric patients contributing data to PCN member healthcare organizations (HCOs).
Figure 3.
Figure 3.
Representation of 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.
See this image and copyright information in PMC

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