J Doods1, R Bache, M McGilchrist, C Daniel, M Dugas, F Fritz. 1. Justin Doods, Institute of Medical Informatics, University of Münster, Albert-Schweitzer-Campus 1, Gebäude A11, 48149 Münster, Germany, E-mail: Justin.Doods@uni-muenster.de.
Abstract
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 re-use EHR data for feasibility queries distributed over the EHR4CR platform.
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 re-use EHR data for feasibility queries distributed over the EHR4CR platform.
Entities:
Keywords:
Protocol feasibility; clinical research; clinical trials; electronic health records; secondary use
Authors: Jie Xu; Luke V Rasmussen; Pamela L Shaw; Guoqian Jiang; Richard C Kiefer; Huan Mo; Jennifer A Pacheco; Peter Speltz; Qian Zhu; Joshua C Denny; Jyotishman Pathak; William K Thompson; Enid Montague Journal: J Am Med Inform Assoc Date: 2015-07-29 Impact factor: 4.497
Authors: Guoqian Jiang; Richard C Kiefer; Luke V Rasmussen; Harold R Solbrig; Huan Mo; Jennifer A Pacheco; Jie Xu; Enid Montague; William K Thompson; Joshua C Denny; Christopher G Chute; Jyotishman Pathak Journal: J Biomed Inform Date: 2016-07-05 Impact factor: 6.317
Authors: Maryam Y Garza; Michael Rutherford; Sahiti Myneni; Susan Fenton; Anita Walden; Umit Topaloglu; Eric Eisenstein; Karan R Kumar; Kanecia O Zimmerman; Mitra Rocca; Gideon Scott Gordon; Sam Hume; Zhan Wang; Meredith Zozus Journal: AMIA Annu Symp Proc Date: 2021-01-25
Authors: Martin Bialke; Peter Penndorf; Tim Wegner; Thomas Bahls; Christoph Havemann; Jens Piegsa; Wolfgang Hoffmann Journal: J Transl Med Date: 2015-06-04 Impact factor: 5.531
Authors: Iñaki Soto-Rey; Aurèle N'Dja; James Cunningham; Axel Newe; Benjamin Trinczek; Caroline Lafitte; Brita Sedlmayr; Fleur Fritz Journal: Biomed Res Int Date: 2015-10-11 Impact factor: 3.411
Authors: Alexander Kiel; Raphael W Majeed; Julian Gruendner; Noemi Deppenwiese; Michael Folz; Thomas Köhler; Björn Kroll; Hans-Ulrich Prokosch; Lorenz Rosenau; Mathias Rühle; Marc-Anton Scheidl; Christina Schüttler; Brita Sedlmayr; Alexander Twrdik Journal: JMIR Med Inform Date: 2022-05-25