Back to Search Start Over

Cost-benefit assessment of using electronic health records data for clinical research versus current practices: Contribution of the Electronic Health Records for Clinical Research (EHR4CR) European Project.

Authors :
Beresniak, Ariel
Schmidt, Andreas
Proeve, Johann
Bolanos, Elena
Patel, Neelam
Ammour, Nadir
Sundgren, Mats
Ericson, Mats
Karakoyun, Töresin
Coorevits, Pascal
Kalra, Dipak
De Moor, Georges
Dupont, Danielle
Source :
Contemporary Clinical Trials. Jan2016, Vol. 46, p85-91. 7p.
Publication Year :
2016

Abstract

Introduction The widespread adoption of electronic health records (EHR) provides a new opportunity to improve the efficiency of clinical research. The European EHR4CR ( Electronic Health Records for Clinical Research ) 4-year project has developed an innovative technological platform to enable the re-use of EHR data for clinical research. The objective of this cost–benefit assessment (CBA) is to assess the value of EHR4CR solutions compared to current practices, from the perspective of sponsors of clinical trials. Materials and methods A CBA model was developed using an advanced modeling approach. The costs of performing three clinical research scenarios (S) applied to a hypothetical Phase II or III oncology clinical trial workflow (reference case) were estimated under current and EHR4CR conditions, namely protocol feasibility assessment (S1), patient identification for recruitment (S2), and clinical study execution (S3). The potential benefits were calculated considering that the estimated reduction in actual person–time and costs for performing EHR4CR S1, S2, and S3 would accelerate time to market (TTM). Probabilistic sensitivity analyses using Monte Carlo simulations were conducted to manage uncertainty. Results Should the estimated efficiency gains achieved with the EHR4CR platform translate into faster TTM, the expected benefits for the global pharmaceutical oncology sector were estimated at €161.5 m (S1), €45.7 m (S2), €204.5 m (S1 + S2), €1906 m (S3), and up to €2121.8 m (S1 + S2 + S3) when the scenarios were used sequentially. Conclusions The results suggest that optimizing clinical trial design and execution with the EHR4CR platform would generate substantial added value for pharmaceutical industry, as main sponsors of clinical trials in Europe, and beyond. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
15517144
Volume :
46
Database :
Academic Search Index
Journal :
Contemporary Clinical Trials
Publication Type :
Academic Journal
Accession number :
111823873
Full Text :
https://doi.org/10.1016/j.cct.2015.11.011