Summary
Background: Pharmaceutical clinical trials are primarily conducted across many countries, yet
recruitment numbers are frequently not met in time. Electronic health records store
large amounts of potentially useful data that could aid in this process. The EHR4CR
project aims at re-using EHR data for clinical research purposes.
Objective: To evaluate whether the protocol feasibility platform produced by the Electronic
Health Records for Clinical Research (EHR4CR) project can be installed and set up
in accordance with local technical and governance requirements to execute protocol
feasibility queries uniformly across national borders.
Methods: We installed specifically engineered software and warehouses at local sites. Approvals
for data access and usage of the platform were acquired and terminology mapping of
local site codes to central platform codes were performed. A test data set, or real
EHR data where approvals were in place, were loaded into data warehouses. Test feasibility
queries were created on a central component of the platform and sent to the local
components at eleven university hospitals.
Results: To use real, de-identified EHR data we obtained permissions and approvals from ‘data
controllers‘ and ethics committees. Through the platform we were able to create feasibility
queries, distribute them to eleven university hospitals and retrieve aggregated patient
counts of both test data and de-identified EHR data.
Conclusion: It is possible to install a uniform piece of software in different university hospitals
in five European countries and configure it to the requirements of the local networks,
while complying with local data protection regulations. We were also able set up ETL
processes and data warehouses, to reuse EHR data for feasibility queries distributed
over the EHR4CR platform.
Keywords
Protocol feasibility - clinical trials - electronic health records - secondary use
- clinical research
