National Library of Medicine, National Institutes of Health, Department of Health and Human Services, Bethesda MD 20894, USA.
National Library of Medicine, National Institutes of Health, Department of Health and Human Services, Bethesda MD 20894, USA
BMJ. 2018 May 25;361:k1452. doi: 10.1136/bmj.k1452.
ClinicalTrials.gov, a repository of information about clinical studies and their results, together with specialised search tools, provides a unique window into the clinical research enterprise, which includes all initiated, ongoing, and completed or terminated clinical studies. Researchers are increasingly using information from the database to assess research reporting practices, or to characterise the clinical research enterprise. Conducting valid analyses requires an understanding of both the capabilities and limitations of the database (that is, intrinsic factors) as well as reporting policies and other factors external to the database that influence the types of studies in ClinicalTrials.gov in a specified time. This article discusses 10 key issues that researchers need to consider when using the database to conduct research.
ClinicalTrials.gov 是一个临床研究及其结果信息库,配有专业的搜索工具,为临床研究领域提供了一个独特的窗口,囊括了所有已启动、正在进行、已完成或已终止的临床研究。研究人员越来越多地利用数据库中的信息来评估研究报告的实践情况,或描述临床研究领域的情况。要进行有效的分析,需要了解数据库的功能和局限性(即内在因素),以及影响特定时间内 ClinicalTrials.gov 中研究类型的报告政策和数据库以外的其他因素。本文讨论了研究人员在使用该数据库进行研究时需要考虑的 10 个关键问题。