Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study
Comparison of paper-based and electronic data collection process in clinical trials: Costs simulation study
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DOI：
10.1016/j.cct.2009.03.008
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发表时间：
2009-07-01
影响因子：
2.2
通讯作者：
Miklavcic, Damijan
中科院分区：
文献类型：
--
作者：
Pavlovic, Ivan;Kern, Tomaz;Miklavcic, Damijan
临床试验纸质数据收集 (PDC) 的替代方案是基于互联网的电子数据收集 (EDC)，研究人员通过互联网直接在电子数据库中输入数据。在我们的研究中，我们将临床试验视为一个业务流程。我们的目标是对 PDC 和 EDC 流程进行建模，并根据这些模型估计样本临床试验的 PDC 和 EDC 流程成本差异。我们使用扩展事件驱动流程链 (eEPC) 建模技术对 PDC 和 EDC 流程进行建模。为了评估流程的成本，我们将成本函数分配给模型中出现的每个流程函数。这些功能中出现的参数包括工作量、员工价格和数据质量参数。我们估计了所有这些参数的值，并对样本临床试验进行了成本计算。通过分析和建模工作，我们确定了子流程，其中包含影响 PDC 和 EDC 流程的持续时间和成本的主要差异：在研究中心收集数据：监控；和数据管理。 PDC和EDC流程最显着的模型差异出现在数据管理子流程中。对于我们的模拟研究和参数估计中考虑的样本临床试验，EDC 流程将数据收集成本降低了 55%。对于不同的参数变化情况，我们表明，与 PDC 工艺相比，EDC 工艺可节省 49% 到 62% 的成本。 (C) 2009 Elsevier Inc. 保留所有权利。
An alternative to clinical trial paper-based data collection (PDC) is internet based electronic data collection (EDC), where the investigators over the internet enter data directly in the electronic database by themselves. In our study we considered clinical trial as a business process. Our objective was to model PDC and EDC process and to estimate the difference of the costs of PDC and EDC process for a sample clinical trial based on these models.We used Extended Event-driven Process Chains (eEPC) modeling technique to model PDC and EDC process. In order to evaluate the costs of the processes we assigned costs functions to each process function which appears in the model. The parameters which appear in these functions include efforts, staff prices and data quality parameters. We estimated the values of all these parameters and performed costs calculations for a sample clinical trial.Through an analysis and modeling efforts we identified sub-processes which contain main differences affecting duration and costs of the PDC and EDC process: data gathering at the research center: monitoring; and data management. The most significant model difference between PDC and EDC process appeared in data management sub-process. For the sample clinical trial considered in our simulation study and our parameters estimations the EDC process decreased data collection costs for 55%. For different scenarios of parameters variations we show that the EDC process may bring from 49% to 62% of savings when compared to PDC process. (C) 2009 Elsevier Inc. All rights reserved.