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.
Contemp Clin Trials
; 46: 85-91, 2016 Jan.
Article
em En
| MEDLINE
| ID: mdl-26600286
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 ANDMETHODS:
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.Palavras-chave
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MEDLINE
Assunto principal:
Simulação por Computador
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Ensaios Clínicos como Assunto
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Análise Custo-Benefício
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Pesquisa Biomédica
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Registros Eletrônicos de Saúde
Idioma:
En
Ano de publicação:
2016
Tipo de documento:
Article