我国药品临床试验数据清理问题及对策研究  

On Problems and Countermeasures of Drug Clinical Trial Data Cleanup in China

作　　者：韩煦[1] 罗鸿锋 张大为[1] Han Xu;Luo Hongfeng;Zhang Dawei(School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学工商管理学院,沈阳110016

出　　处：《中国药事》2018年第7期853-857,共5页Chinese Pharmaceutical Affairs

摘　　要：目的:分析现阶段我国药物临床试验数据清理存在的问题,在借鉴发达国家经验的基础上,提出我国药物临床试验数据清理的对策和建议。方法:采用文献检索和典型国家经验分析的方法。结果:我国在药品临床试验数据清理法律法规、监督管理以及高素质专业数据清理人才培养等方面亟待发展和完善。结论:应进一步完善药物临床试验数据清理法规;保障EDC系统内的数据安全;CRF设计方案应更加专业化;数据转换实现标准化;加大培养高素质专业化临床试验数据清理人才队伍的力度。Objective： To analyze the existing problems of drug clinical trial data cleanup in China and to put forward countermeasures and suggestions based on the experience of foreign developed countries. Methods： Literature retrieval and typical national empirical analysis were used. Results： The relevant laws and regulations on drug clinical trial data cleanup need to be perfected, the supervision and management should be enhanced, and the high-quality professional talents of data cleanup need to be cultivated. Conclusion： The regulation of drug clinical trial data cleanup should be further improved to ensure the data security in EDC system. CRF design scheme should be more professional to achieve the standardization of data conversion. Moreover, the cultivation of high-quality professional data cleanup talents should be strengthened.

关 键 词：药品临床试验 数据清理 监管 专业人才培养 

分 类 号：R197[医药卫生—卫生事业管理] R95[医药卫生—公共卫生与预防医学]