美国国立药物滥用研究所临床试验网络的集中式信息学基础设施。

A centralized informatics infrastructure for the National Institute on Drug Abuse Clinical Trials Network.

作者信息

Pan Jeng-Jong, Nahm Meredith, Wakim Paul, Cushing Carol, Poole Lori, Tai Betty, Pieper Carl F

机构信息

Veterans Health Administration, Washington, DC, USA.

出版信息

Clin Trials. 2009 Feb;6(1):67-75. doi: 10.1177/1740774508100983.

DOI:10.1177/1740774508100983

PMID:19254937

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2962616/

Abstract

BACKGROUND

Clinical trial networks (CTNs) were created to provide a sustaining infrastructure for the conduct of multisite clinical trials. As such, they must withstand changes in membership. Centralization of infrastructure including knowledge management, portfolio management, information management, process automation, work policies, and procedures in clinical research networks facilitates consistency and ultimately research.

PURPOSE

In 2005, the National Institute on Drug Abuse (NIDA) CTN transitioned from a distributed data management model to a centralized informatics infrastructure to support the network's trial activities and administration. We describe the centralized informatics infrastructure and discuss our challenges to inform others considering such an endeavor.

METHODS

During the migration of a clinical trial network from a decentralized to a centralized data center model, descriptive data were captured and are presented here to assess the impact of centralization.

RESULTS

We present the framework for the informatics infrastructure and evaluative metrics. The network has decreased the time from last patient-last visit to database lock from an average of 7.6 months to 2.8 months. The average database error rate decreased from 0.8% to 0.2%, with a corresponding decrease in the interquartile range from 0.04%-1.0% before centralization to 0.01-0.27% after centralization. Centralization has provided the CTN with integrated trial status reporting and the first standards-based public data share. A preliminary cost-benefit analysis showed a 50% reduction in data management cost per study participant over the life of a trial.

LIMITATIONS

A single clinical trial network comprising addiction researchers and community treatment programs was assessed. The findings may not be applicable to other research settings.

CONCLUSIONS

The identified informatics components provide the information and infrastructure needed for our clinical trial network. Post centralization data management operations are more efficient and less costly, with higher data quality.

摘要

背景

临床试验网络（CTNs）的建立是为开展多中心临床试验提供持续的基础设施。因此，它们必须经受住成员变化的影响。临床研究网络中基础设施的集中化，包括知识管理、项目组合管理、信息管理、流程自动化、工作政策和程序，有助于实现一致性并最终推动研究工作。

目的

2005年，美国国立药物滥用研究所（NIDA）临床试验网络从分布式数据管理模式转变为集中式信息学基础设施，以支持该网络的试验活动和管理工作。我们描述了这种集中式信息学基础设施，并讨论了我们所面临的挑战，以便为其他考虑进行此类工作的人提供参考。

方法

在一个临床试验网络从分散式数据中心模式向集中式数据中心模式迁移的过程中，收集了描述性数据并在此呈现，以评估集中化的影响。

结果

我们展示了信息学基础设施的框架和评估指标。该网络已将从最后一名患者最后一次访视到数据库锁定的时间从平均7.6个月缩短至2.8个月。平均数据库错误率从0.8%降至0.2%，四分位距也相应从集中化前的 0.04% - 1.0%降至集中化后的0.01% - 0.27%。集中化使临床试验网络能够进行综合试验状态报告，并实现了首个基于标准的公共数据共享。初步成本效益分析表明，在一项试验的整个周期内，每位研究参与者的数据管理成本降低了50%。