title: 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.
abstract: BACKGROUND
  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.
  
  
  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 €161.5m (S1), €45.7m (S2), €204.5m (S1+S2), €1906m (S3), and up to €2121.8m (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.
authors.affiliation: Data Mining International, Route de l'Aéroport, 29-31, CP 221, Geneva CH-1215, Switzerland.
authors.forename: Ariel
authors.initials: A
authors.lastname: Beresniak
authors.affiliation: F Hoffmann-La Roche Ltd, Grenzacherstrasse 124, Basel 4070, Switzerland.
authors.forename: Andreas
authors.initials: A
authors.lastname: Schmidt
authors.affiliation: Bayer Healthcare, Building K9, Leverkusen 51368, Germany.
authors.forename: Johann
authors.initials: J
authors.lastname: Proeve
authors.affiliation: Eli Lilly and Company, Avenida de la Industria, n 30, Alcobendas 28108, Spain.
authors.forename: Elena
authors.initials: E
authors.lastname: Bolanos
authors.affiliation: Eli Lilly and Company (Until December 2013), Erl Wood Manor, Windlesham, Surrey, United Kingdom.
authors.forename: Neelam
authors.initials: N
authors.lastname: Patel
authors.affiliation: Sanofi-Aventis R&D, 1 avenue Pierre Brossolette, Chilly-Mazarin F-91380, France.
authors.forename: Nadir
authors.initials: N
authors.lastname: Ammour
authors.affiliation: AstraZeneca, Karragatan 1, Mölndal SE 431 83, Sweden.
authors.forename: Mats
authors.initials: M
authors.lastname: Sundgren
authors.affiliation: Amgen, 62, Boulevard Victor Hugo, Neuilly-sur-Seine 92523, France.
authors.forename: Mats
authors.initials: M
authors.lastname: Ericson
authors.affiliation: Heinrich-Heine-Universität Düsseldorf, Germany (Until March 2015), Moorenstraße 5, 40225 Düsseldorf, Deutschland.
authors.forename: Töresin
authors.initials: T
authors.lastname: Karakoyun
authors.affiliation: The European Institute for Health Records (EuroRec), De Pintelaan 185, Ghent 9000, Belgium; Ghent University, Department of Public Health, Unit of Medical Informatics and Statistics, De Pintelaan 185, Ghent B9000, Belgium.
authors.forename: Pascal
authors.initials: P
authors.lastname: Coorevits
authors.affiliation: The European Institute for Health Records (EuroRec), De Pintelaan 185, Ghent 9000, Belgium.
authors.forename: Dipak
authors.initials: D
authors.lastname: Kalra
authors.affiliation: Ghent University, Department of Public Health, Unit of Medical Informatics and Statistics, De Pintelaan 185, Ghent B9000, Belgium.
authors.forename: Georges
authors.initials: G
authors.lastname: De Moor
authors.affiliation: Data Mining International, Route de l'Aéroport, 29-31, CP 221, Geneva CH-1215, Switzerland. Electronic address: ddupont@datamining-international.com.
authors.forename: Danielle
authors.initials: D
authors.lastname: Dupont
mesh_terms: D035843:Biomedical Research / Q000191:economics* / Q000379:methods; D002986:Clinical Trials as Topic / Q000191:economics* / Q000379:methods; D017322:Clinical Trials, Phase II as Topic / Q000191:economics / Q000379:methods; D017326:Clinical Trials, Phase III as Topic / Q000191:economics / Q000379:methods; D003198:Computer Simulation; D003362:Cost-Benefit Analysis; D057286:Electronic Health Records; D005060:Europe; D005240:Feasibility Studies; D006801:Humans; D009010:Monte Carlo Method
keywords: Clinical trials; Cost–benefit analyses; Electronic health records