中医临床研究中数据管理电子化应用的探索

中医药走向国际化存在着较大困难,这与中医药临床研究的质量普遍偏低有关,而其中重要的原因是研究的数据质量不高,数据管理不完善密切相关。目前国内普遍的数据管理模式是通过纸质CRF的记录,研究结束后进行汇集整理的终点管理模式,这导致了数据时效性降低,也带来了监察的难度,以及数据原始性丧失的可能性。本文就晚期肠癌中医综合治疗验证方案的多中心前瞻性队列研究中实施建立基于互联网技术的数据管理系统,实现数据的实时动态管理,中医药临床试验数据管理的电子化,从而大幅提高临床研究效率进行了讨论。

Exploration of Application Status in Electronic Data Management of TCM Clinical Studies

The internationalization process of traditional Chinese medicine (TCM) still faces considerable difficulties.It is due to low quality of general TCM clinical research, and mostly low quality of research data and imperfect datamanagement. Currently, the common data management in China is destination mode which records, collects and analyzes clinical papers after research. This leads to low data timeliness, makes monitoring difficult and increases possibilities of losing data primitiveness. The Department of Oncology, Xi Yuan Hospital, China Academy of Chinese Medical Sciences has been assigned to the project supported by the State Administration of TCM, named the "multicenter prospective cohort study validation protocols in advanced colorectal cancer using TCM combined therapy." By discovering development of electronic data management system based on the Internet technology, the data dynamic management has been realized. And this is the beneficial exploration and experiment for the realization of electronic data management within TCM clinical trials.