| 长三角区域药物临床试验运行管理问题的调查研究 |
| 投稿时间：2023-11-01 修订日期：2023-12-17 点此下载全文 |
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| 中文摘要:目的 分析药物临床试验运行管理中存在的问题,并提出针对性的建议。方法 我们对长三角区域多家医疗机构的医务人员进行电子问卷调查。结果 回收有效问卷606份。71%调查对象表示有兴趣学习并参与药物临床试验工作。不同职业和不同学历人员对药物临床试验工作的认知需求,意愿和工作动机方面存在显著差异(P < 0.05)；在药物临床试验工作运行过程中,研究者报告影响临床试验质量的主要因素包括：研究者GCP意识和主观积极性(响应率27%),监查员和研究协调员的工作稳定性(27%),受试者的依从性(45%),试验药物、医疗器械和生物样本的流转全过程的质量控制(52%)以及临床试验机构的信息化水平(30%)。结论 医院、机构及项目团队可采取一系列措施,包括培养和稳定药物临床试验人才队伍,完善药物临床试验质量管理体系,提升工作效率,推动医疗机构药物临床试验工作的高质量发展。 |
| 中文关键词:医疗机构 药物临床试验 运行管理 医务人员 |
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| A survey and research on the operational management issues of drug clinical trials in the Yangtze River Delta region. |
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| Abstract:Objective In order to analyze the problems in the operation and management of drug clinical trials, put forward targeted opinions. Methods An electronic questionnaire survey was conducted among medical staff in a tertiary hospital in several medical institutions in the Yangtze River Delta region. Results 606 valid questionnaires were received. 71% of the respondents expressed their willingness to study and participate in drug clinical trials. There were significant differences in the cognitive demands, willingness and motivation of the respondents with different occupations and educational backgrounds on the drug clinical trial work (P < 0.05). During the operation of drug clinical trials, researchers report the main factors affecting the quality of clinical trials including GCP awareness and subjective enthusiasm of investigators (response rate 27%), job stability of supervisors and research coordinators (27%), compliance of subjects (45%), quality control of the whole process of the circulation of test drugs, medical devices and biological samples (52%), and the informatization level of clinical trial institutions (30%). Conclusion Hospitals, institutions and project teams can take measures to cultivate and stabilize the drug clinical trial talent team, improve the quality management system of drug clinical trials, improve work efficiency, and promote the high-quality development of drug clinical trials in medical institutions. |
| keywords:Medical institutions drug clinical trials operation management medical staff |
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