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Piloting the EHR4CR feasibility platform across Europe.

J Doods1, R Bache, M McGilchrist

  • 1Justin Doods, Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, Gebäude A11, 48149 Münster, Germany,

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Summary

The Electronic Health Records for Clinical Research (EHR4CR) platform enables uniform protocol feasibility queries across European hospitals. This system successfully re-uses electronic health records data for clinical research, overcoming cross-border data challenges.

Keywords:
Protocol feasibilityclinical researchclinical trialselectronic health recordssecondary use

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Area of Science:

  • Clinical Research Informatics
  • Health Data Science
  • Pharmacovigilance

Background:

  • Pharmaceutical clinical trials face recruitment challenges due to international complexities.
  • Electronic Health Records (EHR) contain valuable data for improving clinical research processes.
  • The EHR4CR project focuses on leveraging EHR data for clinical research.

Purpose of the Study:

  • To assess the feasibility of deploying the EHR4CR protocol feasibility platform across diverse European healthcare systems.
  • To evaluate the platform's ability to execute uniform protocol feasibility queries internationally.
  • To ensure compliance with local technical and governance requirements for cross-border research.

Main Methods:

  • Installation of specialized software and data warehouses at local hospital sites.
  • Obtaining necessary data access and usage approvals from relevant authorities.
  • Performing terminology mapping to standardize local site codes.
  • Loading test or de-identified EHR data into data warehouses.
  • Creating and distributing feasibility queries via the EHR4CR platform to multiple university hospitals.

Main Results:

  • Permissions were secured from data controllers and ethics committees for using de-identified EHR data.
  • The platform facilitated the creation and distribution of feasibility queries to eleven university hospitals.
  • Aggregated patient counts were successfully retrieved from both test and real EHR data.

Conclusions:

  • A standardized software solution can be successfully implemented across multiple European university hospitals.
  • The EHR4CR platform can be configured to meet local technical and data protection regulations.
  • ETL processes and data warehouses were established to enable EHR data reuse for distributed feasibility queries.