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| 药物临床试验实施阶段存在问题的问卷调查 |
| Investigation of Problems in Implementing Drug''''s Clinical Trials in China |
| 投稿时间：2006-05-18 修订日期：2006-08-25 |
| DOI： |
| 中文关键词: 药物临床试验 偏倚 质量评价 操作规程 问卷调查 |
| 英文关键词:Clinical trials Implementation Questionnaire survey |
| 基金项目:北京市教委人文社会科学基金 |
| 赵亚利 崔树起 许颖 彭晓霞 |
| [1]首都医科大学公共卫生与家庭医学学院全科医学系,北京100069 [2]北京市延庆县疾病预防控制中心,北京100069 [3]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,北京100069 |
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| 中文摘要: |
| 目的：了解和探讨我国药物临床试验实施阶段存在的主要问题及对策。方法：采取目的抽样方法，以药物临床试验基地为研究现场，以参与过药物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Epidata 3．0录入数据，用SAS8.0软件进行统计分析。结果：148名研究对象中142名参加过药物临床试验的实施，实施中存在的主要问题是向研究对象收取试验用药费用、存在服药的依从性问题、有病例失访或中途退出时增补新病例、试验结果数据较少重复测定、GCP培训力度不够、实施前相关培训效果较低等。结论：培养科学的研究态度、加强培训力度、严格遵守GCP规范、加强质量监督与管理是提高我国药物临床试验实施质量的重要手段与途径。 |
| 英文摘要: |
| Objective:To understand the problems and ways to solve them in the course of drug clinical trials in China.Method:Doctors joining in the clinical trials were asked by questionnaires.The data were recorded by software epi- data 3.0and analyzed by software SAS 8.0.Result:Among 148 responders in this survey,142 doctors took part in the im- plementation of drug's clinical trials.There were some deficiencies during the implementation of clinical trials such as char- ging drug money from patients,patients'bad compliance during taking drugs,addition of new cases when lost cases or drop- ping out cases occurred,few data to be repeatedly measured,low training effect and so on.Conclusion:The important measures of improving the quality of clinical trials include fostering scientific attitudes,enhancing training quality,compl- ying with GCP and strengthening supervision. |
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