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

Béresniak, Ariel; Schmidt, Andreas; Proeve, Johann; Bolaños, Elena; Patel, Neelam; Ammour, Nadir; Sundgren, Mats; Ericson, Mats; Karakoyun, Toeresin; Coorevits, Pascal; Kalra, Dipak; Moor, Georges De; Dupont, Danielle

doi:10.1016/j.cct.2015.11.011

Cited by 51 publications

(43 citation statements)

References 15 publications

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“…In view of escalating R&D costs [1,2], the biopharmaceutical industry is exploring new ways to enhance R&D platforms and to reduce costs. By enabling the reuse of EHR health data for clinical research, the EHR4CR innovative platform provides a new powerful tool to increase the efficiency of clinical research processes [5,[8][9][10][11]. Importantly, by using advanced interoperable electronic data exchange systems, the EHR4CR platform performs protocol feasibility assessment in a seamless manner, simultaneously in multiple countries, across various hospitals, in a matter of minutes rather than the days or weeks under current conditions.…”

Section: Resultsmentioning

confidence: 99%

“…A recent cost-benefit assessment (CBA) conducted by Beresniak et al has assessed the value of the EHR4CR platform compared to current practices for conducting Phase II and III clinical trials in oncology (as the reference case) [11]. This study has established that the EHR4CR platform provides significant added value to clinical trial sponsors for enabling the trustworthy reuse of EHR hospital-based clinical data for clinical research, in compliance with regulatory, legal, ethical and data privacy protection requirements.…”

Section: Resultsmentioning

confidence: 99%

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

Dupont¹,

Béresniak²

2016

J Health Med Inform

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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

Dupont¹,

Béresniak²

2016

J Health Med Inform

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“…As the pharmaceutical industry is remodelling its R&D platforms to enhance its value chain, reduce costs and improve efficiency [3,[49][50][51][52][53], EHR4CR solutions promise to transform the clinical research landscape by enhancing and speeding up existing clinical research processes. Using a scalable approach, the deployment of EHR-enabled solutions for research will generate new business opportunities with significant growth potential for all stakeholders involved, as well as added value for clinical trial sponsors [52,53], for the benefit of patients, health systems, and society [2].…”

Section: Discussionmentioning

confidence: 99%

“…In particular, a cost-benefit assessment [52,53] and a budget impact analysis [54] were carried out from the perspective of primary sponsors of clinical trials, establishing the added value and the financial impact of using EHR4CR solutions compared to current practices. While these assessments were highly conclusive, they are based on validated assumptions, including market readiness in Europe and a swift adoption of EHR4CR…”

Section: Delivering Valuementioning

confidence: 99%

Business analysis for a sustainable, multi-stakeholder ecosystem for leveraging the Electronic Health Records for Clinical Research (EHR4CR) platform in Europe

Dupont¹,

Béresniak²,

Sundgren

et al. 2017

International Journal of Medical Informatics

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IntroductionThe Electronic Health Records for Clinical Research (EHR4CR) technological platform has been developed to enable the trustworthy reuse of hospital electronic health records data for clinical research. The EHR4CR platform can enhance and speed up clinical research scenarios: protocol feasibility assessment, patient identification for recruitment in clinical trials, and clinical data exchange, including for reporting serious adverse events. Our objective was to seed a multi-stakeholder ecosystem to enable the scalable exploitation of the EHR4CR platform in Europe, and to assess its economic sustainability. Materials and methodsMarket analyses were conducted by a multidisciplinary task force to define an EHR4CR emerging ecosystem and multi-stakeholder value chain. This involved mapping stakeholder groups and defining their unmet needs, incentives, potential barriers for adopting innovative solutions, roles and interdependencies. A comprehensive business model, value propositions, and sustainability strategies were developed accordingly.Using simulation modelling (including Monte Carlo simulations) and a 5-year horizon, the potential financial outcomes of the business model were forecasted from the perspective of an EHR4CR service provider. ResultsA business ecosystem was defined to leverage the EHR4CR multi-stakeholder value chain. Value propositions were developed describing the expected benefits of EHR4CR solutions for all stakeholders. From an EHR4CR service provider's viewpoint, the 3 business model simulation estimated that a profitability ratio of up to 1.8 could be achieved at year 1, with potential for growth in subsequent years depending on projected market uptake. ConclusionsBy enhancing and speeding up existing processes, EHR4CR solutions promise to transform the clinical research landscape. The ecosystem defined provides the organisational framework for optimising the value and benefits for all stakeholders involved, in a sustainable manner. Our study suggests that the exploitation of EHR4CR solutions appears profitable and sustainable in Europe, with a growth potential depending on the rates of market and hospital adoption.

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“…There is now also growing evidence that the reuse of EHRs in this way is cost-beneficial to the pharma industry [8] .…”

Section: Introductionmentioning

confidence: 99%

The launch of the European Institute for innovation through health data

Kalra¹,

Sundgren²,

Claerhout³

et al. 2017

J Med Dev Sci

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Abstract:The European Institute for Innovation through Health Data (i~HD) has been formed as one of the sustainable entities arising from the Electronic Health Records for Clinical Research (EHR4CR) and SemanticHealthNet projects, in collaboration with other European Commission projects and initiatives. The vision of i~HD is to become the European organisation of reference for guiding and catalysing the best, most efficient and trustworthy uses of health data and interoperability, for optimizing health and knowledge discovery. i~HD has been established in recognition that there is a need to tackle areas of challenge in the successful scaling up of innovations that rely on high-quality and interoperable health data, to sustain and propagate the results of eHealth research, and to address current-day obstacles to using health data. i~HD was launched at an inaugural conference in Paris, in March 2016. This was attended by over 200 European clinicians, healthcare providers and researchers, representatives of the pharma industry, patient associations, health professional associations, the health ICT industry and standards bodies. The event showcased issues and approaches, that are presented in this paper to highlight the activities that i~HD intends to pursue as enablers of the better uses of health data, for care and research.

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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

Cited by 51 publications

References 15 publications

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

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

Business analysis for a sustainable, multi-stakeholder ecosystem for leveraging the Electronic Health Records for Clinical Research (EHR4CR) platform in Europe

The launch of the European Institute for innovation through health data

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