Shmueli-Blumberg Dikla, Hu Lian, Allen Colleen, Frasketi Michael, Wu Li-Tzy, Vanveldhuisen Paul
aNIDA CTN Clinical Coordinating Center, The EMMES Corporation, Rockville, MD, USA.
Clin Trials. 2013;10(6):977-86. doi: 10.1177/1740774513503522. Epub 2013 Oct 1.
There are many benefits of data sharing, including the promotion of new research from effective use of existing data, replication of findings through re-analysis of pooled data files, meta-analysis using individual patient data, and reinforcement of open scientific inquiry. A randomized controlled trial is considered as the 'gold standard' for establishing treatment effectiveness, but clinical trial research is very costly, and sharing data is an opportunity to expand the investment of the clinical trial beyond its original goals at minimal costs.
We describe the goals, developments, and usage of the Data Share website (http://www.ctndatashare.org) for the National Drug Abuse Treatment Clinical Trials Network (CTN) in the United States, including lessons learned, limitations, and major revisions, and considerations for future directions to improve data sharing.
Data management and programming procedures were conducted to produce uniform and Health Insurance Portability and Accountability Act (HIPAA)-compliant de-identified research data files from the completed trials of the CTN for archiving, managing, and sharing on the Data Share website.
Since its inception in 2006 and through October 2012, nearly 1700 downloads from 27 clinical trials have been accessed from the Data Share website, with the use increasing over the years. Individuals from 31 countries have downloaded data from the website, and there have been at least 13 publications derived from analyzing data through the public Data Share website.
Minimal control over data requests and usage has resulted in little information and lack of control regarding how the data from the website are used. Lack of uniformity in data elements collected across CTN trials has limited cross-study analyses.
The Data Share website offers researchers easy access to de-identified data files with the goal to promote additional research and identify new findings from completed CTN studies. To maximize the utility of the website, ongoing collaborative efforts are needed to standardize the core measures used for data collection in the CTN studies with the goal to increase their comparability and to facilitate the ability to pool data files for cross-study analyses.
数据共享有诸多益处，包括通过有效利用现有数据促进新研究、通过对汇总数据文件的重新分析复制研究结果、使用个体患者数据进行荟萃分析以及加强开放的科学探究。随机对照试验被视为确立治疗效果的“金标准”，但临床试验研究成本高昂，而数据共享是以最小成本将临床试验投资扩展至超出其原有目标的契机。
我们描述了美国国家药物滥用治疗临床试验网络（CTN）的数据共享网站（http://www.ctndatashare.org）的目标、发展情况及使用情况，包括经验教训、局限性、重大修订以及对改进数据共享未来方向的考量。
开展数据管理和编程程序，以便从CTN已完成的试验中生成统一且符合《健康保险流通与责任法案》（HIPAA）规定的去标识化研究数据文件，用于在数据共享网站上存档、管理和共享。
自2006年创建至2012年10月，数据共享网站已有来自27项临床试验的近1700次下载，且使用量逐年增加。来自31个国家的个人从该网站下载了数据，并且至少有13篇出版物是通过分析公共数据共享网站上的数据得出的。
对数据请求和使用的控制极少，导致关于网站数据使用方式的信息极少且缺乏控制。CTN各项试验收集的数据元素缺乏一致性，限制了跨研究分析。
数据共享网站为研究人员提供了便捷获取去标识化数据文件的途径，旨在促进更多研究并从已完成的CTN研究中发现新成果。为使该网站的效用最大化，需要持续的协作努力，以规范CTN研究中用于数据收集的核心指标，目标是提高其可比性并便于汇总数据文件进行跨研究分析。
