Journal of Health & Medical Informatics

ISSN: 2157-7420

Open Access

Assessing the Financial Impact of Reusing Electronic Health Records Data for Clinical Research: Results from the EHR4CR European Project


Danielle Dupont, Ariel Beresniak, Andreas Schmidt, Johann Proeve, Elena Bolanos, Nadir Ammour, Mats Sundgren, Mats Ericson, Dipak Kalra and Georges De Moor

Background: The new technological platform developed by the Electronic Health Records for Clinical Research (EHR4CR) European research project (2011-2016) has been specially designed to enable the trustworthy reuse of health data contained in hospital-based electronic health records (EHR) for enhancing and speeding up clinical research scenarios. In particular, protocol feasibility assessments, patient identification for recruitment, and clinical data exchange for study conduct, in accordance with data privacy, ethical and legal requirements. The objective of our study was to assess the financial impact of adopting these advanced solutions compared to current practices, from the perspective of the primary sponsors of clinical trials in Europe.
Methods: Considering a scalable implementation of EHR4CR solutions in up to 5-10% of Phase II, III and IV clinical trials to be commercially sponsored in Europe over 5 years, two potential market sizes were defined. The first has a European initial scope (i.e., for European clinical trials only), and the second has a European subsequent broader scope (also including European arms of global studies). Based on expert opinions, the EHR4CR initial scope target market was estimated to be 30% of the broader scope. Direct costs to clinical research sponsors were estimated under current practices, and with the EHR4CR platform. Uncertainty was managed using 100,000 Monte Carlo simulations.
Results: Compared to current practices, the potential average 5-year savings with EHR4CR solutions for Phase II, III and IV commercially sponsored clinical trials in Europe were estimated at €175.5 m for the European initial scope market, and at €585.3 m for the European broader scope market. These results were confirmed by robust probabilistic sensitivity analyses.
Conclusions: Compared to current practices, EHR4CR solutions appear cost-saving for primary sponsors of clinical trials. These results suggest that the potential for savings would increase with a broader adoption of EHR4CR solutions in Europe, and beyond.


Share this article

Google Scholar citation report
Citations: 2128

Journal of Health & Medical Informatics received 2128 citations as per Google Scholar report

Journal of Health & Medical Informatics peer review process verified at publons

Indexed In

arrow_upward arrow_upward