临床试验数据管理培训——现状、经验与展望  

The Current Situation,Experience and Prospect of Clinical Data Management Training

作　　者：吴美京[1] 吴骋[1] 王睿[1] 贺佳[1] 

机构地区：[1]第二军医大学卫生统计学教研室,上海200433

出　　处：《西北医学教育》2009年第5期857-858,919,共3页Northwest Medical Education

基　　金：国家"十一五""重大新药创制科技重大专项"新药临床研究技术平台建设-抗慢性乙型病毒性肝炎新药临床评价研究平台的构筑分题:数据管理和统计分析的平台建设(2008ZX09312-007);第二军医大学卫勤系教学研究与改革项目"公共事业管理本科‘军队卫生管理统计学’专业化双模块改革研究"

摘　　要：随着跨国制药企业在中国的迅猛发展,国内制药公司的快速成长,以及临床试验标准的不断提高,对数据管理人才的需求也日益增长。然而,我国临床数据管理依然缺乏职业性认识,临床数据管理人才的培训现状和水平与国外发达国家相比,相对落后。在简要比较国内外临床数据管理培训现状的基础上,结合我们在举办国内临床数据管理培训班过程中所获得的经验,对我国临床数据管理培训现状进行分析并针对如何更好地培训临床数据管理人才、提高国内临床数据管理质量提出建议。With the expansion of multinational pharmaceutical companies in China, rapid growth of local pharmaceutical industry and increasing standards for clinical trial, demands for data management expertise are expected to be on a sharp rise. However, data management has not yet been recognized as a profession in China, the training of clinical data management right now also remains depressingly far off. Based on the comparison between the domestic and international situation in clinical data management training as well as on our training experience, this paper is to illuminate the current situation of clinical data management training in China and put forward some suggestions on how to provide better training for clinical data management talents and enhance the quality of clinical data management in China.

关 键 词：临床试验 临床数据管理 培训 

分 类 号：G642.45[文化科学—高等教育学]