中国中医科学院广安门医院药物临床试验者问卷调查结果分析

Questionnaire Survey for Researchers of Medicine Clinical Trial in Guang'anmen Hospital of China Academy of Chinese Medical Sciences

目的了解中国中医科学院广安门医院(以下简称"广安门医院")临床研究者的状况及需求。方法采用自填式问卷调查方式,以广安门医院临床专业所有持"药物临床试验质量管理规范"(GCP)证书的医护人员为调查对象,就对科室临床试验质量的认可程度、参与的主动性及对GCP知识需求3个方面进行调查。数据采用SPSS11.5统计软件进行分析。结果 95.6%研究者认为临床试验过程规范,89.9%研究者认为临床试验质量高,绝大多数研究者主动参与临床试验(86.9%),认为其有助于提高科研能力和发表学术论文。结论绝大多数研究者熟悉GCP知识,能主动参与临床试验,并希望得到更多培训。

Objective To understand the status and requirement of the clinical researchers in Guang'anmen Hospital of China Academy of Chinese Medical Sciences(hereinafter referred to as Guang'anmen Hospital). Methods Self-filling questionnaire was used. All medical care personnel in the clinical specialty with the GCP qualification were set as respondents. The three aspects of recognition degree of clinical trials quality, initiative of participation and knowledge demand for GCP were investigated. Data were analyzed through SPSS11.5. Results 95.6% of clinical researchers considered that the course of clinical trial was legal;89.9% of clinical researchers believed that the quality of clinical trial was good. Most clinical researchers participated in the clinical trials actively(86.9%) and they considered that the trials were helpful for them to enhance research ability and to issue paper. Conclusion Clinical researchers are familiar with GCP knowledge and can participate in the clinical trials actively. They still expect to learn more.