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
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
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DOI：
10.1016/j.cct.2015.11.011
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发表时间：
2016-01-01
影响因子：
2.2
通讯作者：
Dupont, Danielle
中科院分区：
文献类型：
--
作者：
Beresniak, Ariel;Schmidt, Andreas;Dupont, Danielle
电子健康记录（EHR）的广泛采用为提高临床研究效率提供了新的机会。欧洲EHR 4CR（临床研究电子健康记录）4年项目开发了一个创新技术平台，可以在临床研究中重复使用EHR数据。这种成本效益评估（CBA）的目的是评估EHR4CR解决方案的价值相比，目前的做法，从赞助商的临床试验的角度来看，Materials and Methods：CBA模型开发使用先进的建模方法。在当前和EHR4CR条件下，估计了应用于假设II期或III期肿瘤临床试验工作流程（参考病例）的三种临床研究场景（S）的成本，即方案可行性评估（S1）、招募患者识别（S2）和临床研究执行（S3）。考虑到执行EHR 4CR S1、S2和S3的实际人员时间和成本的估计减少将加快上市时间（TTM），计算了潜在受益。使用蒙特卡罗模拟进行概率敏感性分析，以管理不确定性。如果EHR4CR平台实现的估计效率增益转化为更快的TTM，全球药物肿瘤学部门的预期收益估计为（原文如此）161.5 m（S1），（原文如此）45.7 m（S2），（原文如此）204.5 m（S1 + S2），结论：结果表明，优化临床试验设计和执行与EHR4CR平台将产生大量的附加值制药行业，在欧洲和超越临床试验的主要赞助商。(C)2015 Elsevier Inc. All rights reserved.
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 (sic)161.5 m (S1), (sic)45.7 m (S2), (sic)204.5 m (S1 + S2), (sic)1906 m (S3), and up to (sic)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. (C) 2015 Elsevier Inc. All rights reserved.