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Characterization of Patients in the TriNetX Database

Basic Details
Status
Complete
Last Updated
Wednesday, January 15, 2025
Original Posting Date
Health Outcome(s)
characterization
Purpose
Methods, Characterization, or Development
Meets requirements of FD&C Act Sec 505(o) prior to requiring a PMR
No
Study Summary

The U.S. Food and Drug Administration (FDA) pursued this study to characterize the TriNetX Live™ platform data within the Sentinel System, as these data may be used for future Sentinel studies. FDA sought to better understand attributes of the available data, including the extent to which Health Care Organization (HCO) data had date shifting (a part of data sources’ privacy preserving measures) and whether date shifting may impact future study approaches.

Results provided demographic and geographic patterns of data stratified by whether the data sources underwent date shifting. As the FDA pursued this study for the purpose of methods and development, no regulatory action was needed as a result of this study.