Piloting the EHR4CR feasibility platform across Europe

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.