临床试验数据质量问题与改进措施  

Analysis of data quality in clinical trials

作　　者：黄傲[1] 孙瑞华[2] 王雨萌[1] 李欢[1] 徐凯[1] 杨存霞[1] 顾泽龙[1] 

机构地区：[1]北京中医药大学管理学院,北京100029 [2]中日友好医院科研与学科建设部,北京100029

出　　处：《中日友好医院学报》2015年第4期224-227,共4页Journal of China-Japan Friendship Hospital

摘　　要：目的:分析临床试验数据管理过程中常见的数据质量问题,探讨问题来源与产生原因,为提高数据质量提供依据。方法:对选取的10项多中心、随机、双盲临床试验的疑问表,按照模块和疑问类型进行分析,从数据管理实际归纳疑问来源,并进行疑问原因总结。结果:按模块划分,疑问主要分布在实验室检查、疗效数据、时间和日期数据3个模块。按疑问类型划分,主要集中于缺失值和逻辑异常两类。病例报告表设计不合理、研究者对试验方案及标准操作规程依从性不高、药物临床试验质量管理规范知识掌握不充分、研究者、临床协调员和监察员未尽责、申办方及合同研究组织向数据管理人员提供信息不充分等是造成缺陷数据的常见原因。结论:在试验研究过程的不同阶段均应重视数据质量,以提高临床试验的数据可靠性。Objective：To analyze the data quality of clinical trials and give recommendation for improvement in the data management.Methods：Questionnaires from ten multicenter, randomized , double -blind clinical trials were collected and analyzed according to the models of case report form （CRF）and types of queries.The sources and causes of queries in the routine data management were summarized.Results：The laboratory test, efficacy data,time ＆ date data were the major sources among the CRF models.And missing data,logistic ab- normal data were the main types of queries.The causes of flawed data included： （1）low compliance of the in- vestigator to the protocol and SOPs; （2）unfamiliar with the knowledge of good clinical practice; （3）irresponsi- bility of the investigator, cooperative research association （CRA）and monitor; （4）insufficient information provided by the sponsor and the contract research organization.Conclusion：To enhance the data quality, more attention should be paid to the common reasons in the different stage of clinical trial.

关 键 词：临床试验 数据质量 疑问来源 缺陷数据 

分 类 号：R95[医药卫生—药学]