Development of common data elements: the experience of and recommendations from the early detection research network
Development of common data elements: the experience of and recommendations from the early detection research network
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DOI：
10.1016/s1386-5056(03)00005-4
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发表时间：
2003-04-01
影响因子：
4.9
通讯作者：
Feng, ZD
中科院分区：
文献类型：
--
作者：
Winget, MD;Baron, JA;Feng, ZD
近年来，由美国国家癌症研究所（NCI）资助的大型研究联盟越来越多，以促进多学科，多机构的癌症研究。其中一些联盟有类似于多中心临床试验的中央数据收集计划，而其他联盟则计划在本地存储数据，并在以后共享或共享数据。无论联盟的目标是什么，都需要标准化在所涉及的机构中收集和存储、传输或报告某些数据的方式。这份报告是早期检测研究网络（EDRN）开发通用数据元素（CDE）的过程和现状的报告。CDE的开发涉及几个阶段，每个阶段都需要肿瘤学、流行病学、生物统计学、病理学、信息学和研究协调方面的多学科专家的投入。已努力与开发类似CDE的其他联合体保持一致，并在可用时遵循数据标准。最初的重点是确定收集所有EDRN研究参与者和EDRN标本所需的最低数据。目前，8个不同器官部位和13种不同类型标本采集的CDE处于开发或试验阶段，并计划开发12种或更多类型标本的CDE。(C)2003爱思唯尔科学爱尔兰有限公司保留所有权利。
There have been an increasing number of large research consortia in recent years funded by the National Cancer Institute (NCI) to facilitate multi-disciplinary, multi-institutional cancer research. Some of these consortia have central data collection plans similar to a multi-center clinical trial whereas others plan to store data Locally and pool or share the data at a later date. Regardless of the goal of the consortium, there is a need to standardize the way certain data are collected and stored, transferred, or reported across the institutions involved. This communication is a report of the process and current status of the development of common data elements (CDEs) by the Early Detection Research Network (EDRN). The development of the CDEs involved several stages with each stage requiring input from multidisciplinary experts in oncology, epidemiology, biostatistics, pathology, informatics, and study coordination. An effort was made to be consistent with other consortia developing similar CDEs and to follow data standards when available. Initial focus was on identifying the minimum data that would be necessary to collect on all EDRN study participants and EDRN specimens. There are currently CDEs in the development or pilot phase for eight different organ sites and 13 different types of specimen procurements and plans to develop CDEs for 12 or more additional types of specimens. (C) 2003 Elsevier Science Ireland Ltd. All rights reserved.