药品临床试验设计阶段存在的问题及改进措施

首都医科大学学报 ›› 2005, Vol. 26 ›› Issue (6): 687-690.

药品临床试验设计阶段存在的问题及改进措施

彭晓霞¹, 赵亚利², 许颖³, 吴立娟¹, 崔树起², 王嵬¹

1. 首都医科大学公共卫生与家庭医学学院流行病学与卫生统计学系;2. 首都医科大学公共卫生与家庭医学学院全科医学系;3. 北京市延庆区疾病控制中心

收稿日期:2005-11-08 修回日期:1900-01-01 出版日期:2005-12-24 发布日期:2005-12-24

What's Wrong with the Design of Clinical Trials in China

Peng Xiaoxia¹, Zhao Yali², Xu Ying³, Wu Lijuan¹, Cui Shuqi², Wang Wei¹

1. Department of Biostatistics and Epidemiology, School of the Public Health and Family Medicine, Capital University of Medical Science;2. Department of Family Medicine, School of Public Health and Family Medicine, Capital University of Medical Sciences;3. Centre of Disease Control of Yanqing District

Received:2005-11-08 Revised:1900-01-01 Online:2005-12-24 Published:2005-12-24

摘要/Abstract

摘要： 目的了解中国药品临床试验设计阶段存在的问题,探讨解决的方法。方法采取目的抽样方法,以药品临床试验基地为研究现场,以参与过药品临床试验的医务人员为研究对象,采用自填式问卷调查获取相关问题的答案,应用Epidata3.0进行数据录入,用SAS8.0对结果进行统计分析。结果最终纳入148名研究对象,对其中参与过临床试验设计的40名医务人员进行深入调查,发现在药品临床试验设计中存在的主要问题为统计设计中没有恰当的样本量计算,对照药品选用不当,随机、盲法应用不足等。结论周密、科学的统计设计有助于提高研究效率,保证药品临床试验顺利实施,避免搜集资料时的盲目性和分析资料时的困惑感。建议临床医生在进行药品临床试验方案设计时应重视统计设计。

关键词: 临床试验, 现况调查, 统计设计

Abstract: Objective To find out the problems which needed to resolve during the design phase of clinical trials via questionnaire survey.Methods Clinical doctors who have taken part in clinical trials in the bases of Drug's Clinical Trials were surveyed by questionnaire.The data were recorded by software Epidata 3.0 and analyzed by software SAS8.0 Results Forty doctors who have finished protocols of clinical trials were assigned in this survey.We can draw a conclusion that there are many limitations of statistical design of clinical trials, such as improper calculation of sample size, the insufficient utilization of randomization and blinding, the inappropriate use of control drugs.Conclusion There are some problems in the design of clinical trials, which affected the quality of clinical trials.Therefore designer of clinical trials should pay more attention to the problems mentioned above in order to improve the quality of clinical trials.

Key words: clinical trial, cross-sectional study, statistical design

中图分类号:

R195.1

彭晓霞;赵亚利;许颖;吴立娟;崔树起;王嵬. 药品临床试验设计阶段存在的问题及改进措施[J]. 首都医科大学学报, 2005, 26(6): 687-690.

Peng Xiaoxia;Zhao Yali;Xu Ying;Wu Lijuan;Cui Shuqi;Wang Wei. What's Wrong with the Design of Clinical Trials in China[J]. Journal of Capital Medical University, 2005, 26(6): 687-690.

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