CDISC标准与中医药临床研究数据标准化

临床研究数据标准化越来越受到关注,国际临床研究数据标准主要包括文件格式标准、分析标准、交换标准和术语标准4大类.其中交换标准和分析标准目前备受关注的是CDISC标准.数据管理质量和水平的落后已经成为制约国内临床试验持续、快速和健康发展的桎梏,如何应用国际临床数据标准缩小中医药临床研究与国际先进水平的差距是个不断探索的课题.本文简要就CDISC和其具体的两个标准以及在中医药临床研究数据标准化中的意义进行了较深入的描述和分析,并针对目前中医药临床研究数据全面运用CDISC标准存在的问题进行讨论,提出加强相关中医语义结构及术语标准研究是解决全面应用CIDSC标准问题的关键和必由之路.

CDISC Standards and Clinical Research Data Standardization of Traditional Chinese Medicine

More and more attention has been paid to the standardization of clinical research data. International clinical data standards mainly include four categories, which are file format, analysis standard, exchange standard and terminology standard. CDISC is the main criteria of exchange standard and analysis standard currently. Backwardness of quality and level of the data management has become one of the most important factors that affect the sustained, rapid and healthy development of domestic clinical trial. How to apply international standards of clinical data to narrow the gap of clinical research of Chinese medicine with the international advanced level is a topic which needs to be continuously explored. This paper firstly introduced the CDISC and its two standards, then analyzed the significance of data standardization in clinical research of traditional Chinese medicine (TCM), and finally discussed problems existed in the process of TCM clinical research using CDISC standards. It was suggested that the strengthening on research of relevant TCM semantic structure and its terminology standard is the key problem. The only way to solve this problem is to use the CDISC standards.