节点文献
北京市某三甲医院医务人员参与临床试验现状调查分析及改进策略研究
Study of investigation and analysis of the current situation of medical personnel participating in clinical trials in a tertiary hospital in Beijing and improvement strategies
【摘要】 目的 了解医务人员参与临床试验的现状、认知及理解,剖析制约因素与潜在需求,从机构建设层面提出改进措施,为提升其认知和主动参与度提供参考。方法 选取首都医科大学附属北京地坛医院2019年12月至2025年4月在相关平台备案的临床试验专业的医务人员为研究对象,以便利抽样法发放电子问卷,分别用Microsoft Excel 2019和SPSS 27.0进行数据整理和统计分析。结果 本调查共发放292份问卷,回收有效问卷292份,有效回收率为100.0%。分析结果显示,95.2%的医务人员认为临床试验的要求比临床诊疗更严格,91.1%的人员有参与临床试验的意愿。参与动机方面,发表文章和职称晋升占比最高(74.6%),其次为启发科研思路(64.0%)和获得研究者报酬(52.7%)。制约参与临床试验的因素主要包括临床工作繁忙(62.0%)、团队人力紧张(56.5%)。对于医生群体,年龄和职称是影响其参与临床试验的重要因素。结论 医务人员对临床试验的认知与参与意愿受政策导向、职业需求和资源配置等多重因素影响,存在群体差异及认知盲点,时间冲突和培训不足是主要制约因素。通过构建分层分类培训体系、完善激励保障机制及创新管理模式,可有效提升临床试验质量与效率,为创新药械临床研究提供支撑。
【Abstract】 Objective To investigate the current status, cognition, and understanding of medical staff in participating in clinical trials, analyze the restrictive factors and potential needs, propose improvement measures from the perspective of institutional construction, and to provide references for enhancing their cognition and active participation. Methods Professional medical personnel engaged in clinical trials who had registered on relevant platforms in the Beijing Ditan Hospital, Captial Medical University from December 2019 to April 2025 were selected as the research subjects. Electronic questionnaires were distributed using the convenience sampling method. Microsoft Excel 2019 and SPSS 27.0 were used for data collation and statistical analysis, respectively. Results A total of 292 questionnaires were valid distributed in this study,292 valid questionnaires were recovered, with an effective rate of 100.0%. The analysis showed that 95.2% of the respondents believed that the requirements for clinical trials were stricter than those for clinical diagnosis and treatment, and 91.1% had the willingness to participate. Amongthe motives for participation, publishing articles and professional title promotion accounted for the highest proportion(74.6%), followed by inspiring scientific research ideas(64.0%) and obtaining researchers’ remuneration(52.7%). The main restrictive factors included heavy clinical workload(62.0%) and insufficient team manpower(56.5%). The most demanded training by the respondents was practical training on clinical trials(67.1%). For the physician group, age and professional title were important factors affecting their participation in clinical trials. Conclusion The cognition and willingness of medical staff to participate in clinical trials are affected by multiple factors such as policy orientation, professional needs, and resource allocation, with existing group differences and cognitive blind spots. Time conflicts and insufficient training are the main restrictive factors. By establishing a hierarchical and classified training system, improving incentive and guarantee mechanisms, and innovating management models, the quality and efficiency of clinical trials can be effectively enhanced, thereby providing support for clinical research on innovative drugs and medical devices.
【Key words】 Clinical trials; Investigation; Willingness; Improvement strategies;
- 【文献出处】 中国医药导报 ,China Medical Herald , 编辑部邮箱 ,2026年04期
- 【分类号】R197.3
- 【下载频次】2