多中心临床研究中集中式与分散式电子数据采集的经济分析。
Economic analysis of centralized vs. decentralized electronic data capture in multi-center clinical studies.
作者信息
Walden Anita, Nahm Meredith, Barnett M Edwina, Conde Jose G, Dent Andrew, Fadiel Ahmed, Perry Theresa, Tolk Chris, Tcheng James E, Eisenstein Eric L
机构信息
Duke University, Durham, North Carolina, USA.
出版信息
Stud Health Technol Inform. 2011;164:82-8.
BACKGROUND
New data management models are emerging in multi-center clinical studies. We evaluated the incremental costs associated with decentralized vs. centralized models.
METHODS
We developed clinical research network economic models to evaluate three data management models: centralized, decentralized with local software, and decentralized with shared database. Descriptive information from three clinical research studies served as inputs for these models.
MAIN OUTCOME MEASURES
The primary outcome was total data management costs. Secondary outcomes included: data management costs for sites, local data centers, and central coordinating centers.
RESULTS
Both decentralized models were more costly than the centralized model for each clinical research study: the decentralized with local software model was the most expensive. Decreasing the number of local data centers and case book pages reduced cost differentials between models.
CONCLUSION
Decentralized vs. centralized data management in multi-center clinical research studies is associated with increases in data management costs.
背景
多中心临床研究中正在出现新的数据管理模式。我们评估了分散式与集中式模式相关的增量成本。
方法
我们开发了临床研究网络经济模型来评估三种数据管理模式：集中式、使用本地软件的分散式以及使用共享数据库的分散式。来自三项临床研究的描述性信息用作这些模型的输入。
主要结局指标
主要结局是数据管理总成本。次要结局包括：各研究点、本地数据中心和中央协调中心的数据管理成本。
结果
对于每项临床研究，两种分散式模式的成本均高于集中式模式：使用本地软件的分散式模式成本最高。减少本地数据中心数量和病例记录页数可缩小各模式之间的成本差异。
结论
多中心临床研究中分散式与集中式数据管理会导致数据管理成本增加。
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