摘要
当前我国中医药临床研究质量普遍偏低,其提供的有关中医药有效性和安全性的证据强度较弱。研究过程中缺乏科学管理,尤其在数据管理环节存在较多问题,是导致中医药研究水平较低的原因之一。因此,加强临床研究过程中的数据管理,对提高中医药临床研究质量十分必要。本文结合国家科技攻关计划项目的具体实践,介绍了数据管理中的核查环节,以供参考。
Based on evidence-based medicine （EBM） and from the viewpoint of providing scientific evidence for clinical application, we found that Traditional Chinese Medicine （TCM） was short of adequate evidence to support its therapeutic effects due to lack of high quality clinical research. Data management plays a very important role in clinical research. Lack of adequate data management may leadto low quality clinical research. Thus, it is of great importance to establish a set of standards for data management so as to improve the quality of clinical research. Based on the real practice in Myocardial Infarction Secondary Prevention Study in TCM （MISPS-TCM）, this article introduces methods on data audit in clinical trials of TCM.
出处
《中国循证医学杂志》
CSCD
2007年第3期230-232,共3页
Chinese Journal of Evidence-based Medicine
基金
国家科技攻关支助项目(2004BA716B01)
关键词
数据管理
数据核查
临床试验
Data management
Data audit
Clinical Trial
