上海交通大学学报（医学版）

›› 2011, Vol. 31 ›› Issue (11): 1638-.doi: 10.3969/j.issn.1674-8115.2011.11.029

• 论著（卫生事业管理） • 上一篇    下一篇

临床医师对临床试验的认知及教育需求现状分析

鲁 菁1,2, 方红娟2, 陈立章1   

  1. 1.中南大学 公共卫生学院, 长沙 410078； 2.中华医学会北京分会, 北京 100005
  • 出版日期:2011-11-28 发布日期:2011-11-29
  • 作者简介:鲁 菁（1970—）, 女, 编辑, 博士生；电子信箱: lu3012010@163.com。

Analysis of cognition of clinicians on clinical trails and their educational demand

LU Jing1,2, FANG Hong-juan2, CHEN Li-zhang1   

  1. 1.School of Public Health, Central South University, Changsha 410078, China；2.Beijing Branch of the Chinese Medical Association, Beijing 100005, China
  • Online:2011-11-28 Published:2011-11-29

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摘要：

目的 探讨临床医师对临床试验的认知水平和受教育需求，对我国临床试验教育提出合理化建议。方法 从北京、济南、杭州和重庆4个城市的5所三级甲等医院参加过临床试验的医师中随机抽取160名临床医师进行问卷调查，回收问卷141份，回收率为88.1%。问卷内容主要包括被调查者的基本情况、对临床试验知识的认知情况（基本知识的认知和最新进展或相关知识的认知）、临床试验培训现状及影响因素。结果 在临床试验基本知识的试验流程、伦理学、监察知识得分以及总得分方面，参加过培训的临床医师显著高于未参加过培训的临床医师（P<0.05）；但在质量控制和数据管理及统计基本知识方面，两组比较差异无统计学意义（P>0.05）。临床医师对临床试验设计水平、临床试验中最新的应用技术和理念以及科学报告试验结果等方面的知识都处于较低的水平。临床医师掌握临床试验基本知识的影响因素为是否参加过培训、学历和职称；临床医师参加培训的影响因素为是否有接受培训的机会、对培训内容的认可程度和工作繁忙程度。结论 我国临床医师对临床试验的认知水平较低，基本上未获系统培训；目前培训虽然缺乏规范性和系统性，但可在一定程度上提高临床医师的认知水平。建立临床试验职业资格准入制度、专业临床试验医师队伍和高素质的师资队伍是提高我国临床试验水平的有效途径。

关键词: 临床医师, 临床试验, 认知, 教育需求

Abstract:

Objective To investigate the cognition of clinicians on clinical trials and their educational demand, and provide reasonable proposals for clinical trial education. Methods A total of 160 clinicians with experience in clinical trials were randomly selected from 5 upper first-class hospitals in Beijing, Jinan, Hangzhou and Chongqing for questionnaire survey. One hundred and forty-one questionnaires were recovered, with the recovery rate of 88.1%. The questionnaire included the basic information of clinicians, cognition of clinicians on clinical trials (basic knowledge, recent advances or relevant knowledge about clinical trials), current situation on clinical trial taining and influencing factors. Results The scores of trial procedure, ethics and monitor knowledge and total score of basic knowledge in clinicians with training were significantly higher than those in clinicians without training (P<0.05), while there was no significant difference in scores of quality control and data management of basic knowledge between clinicians with and without training (P>0.05). The scores of clinical trial design, new technology and idea in clinical trials, and scientific report of findings were lower in clinicians. The influencing factors for mastery of basic knowledge of clinical trials were training participation, educational degree and technical titles, and the influencing factors for training participation were training opportunity, training content and job involvement. Conclusion Clinicians have a poor cognition on clinical trials, and most clinicians have not received systemic training on clinical trials. The current training is not standardized or systemic, but it can improve the cognition of clinicians to some degree. The establishment of occupation qualification system, professional clinician team and qualified teachers for clinical trials is the effective way to improve the clinical trial levels.

Key words: clinician, clinical trial, cognition, educational demand