基于CiteSpace和COOC的中国药物临床试验质量管理的视觉分析
Jiayan Xia1,2, Xuemei Ning1, Lamei Jiang1
1The First Affiliated Hospital of Chengdu Medical College, Clinical Medical College, Chengdu Medical College, Chengdu, China.
Frontiers in medicine
|September 29, 2025
概括
本研究分析了中国的临床试验质量管理 (CTQM),揭示了向人工智能驱动的方法的转变. 未来的发展需要整合政策,技术和伦理,以加强药物研究.
科学领域:
- 临床试验管理 临床试验管理
- 图书统计学 图书统计学
- 卫生政策 卫生政策
背景情况:
- 中国的临床试验质量管理 (CTQM) 取得了进展,但在全球范围内落后.
- 研究旨在绘制中国CTQM热点,合作和趋势的地图.
研究的目的:
- 确定中国CTQM领域的研究热点,协作网络和进化趋势.
- 为优化国内政策提供理论和实践参考.
主要方法:
- 来自中国数据库 (CNKI,万芳,VIP) 的528篇CTQM文章的图书统计和视觉分析.
- 使用CiteSpace和COOC软件进行主题演变分析.
- 在国际数据库 (Scopus,Web of Science,PubMed) 中补充搜索中国学者CTQM出版物.
主要成果:
- 研究经历了三个时期的发展:标准化 (2003-2012),融合 (2013-2019) 和智能转型 (2020-2024).
- 主题从系统本地化转移到风险管理,数据管理和道德治理,由新兴技术驱动.
- 人工智能提高了质量控制的效率,但也引发了数据隐私和伦理方面的担忧;存在强大的政治-学术合作,但跨系统的合作伙伴关系有限.
结论:
- 中国在CTQM中将传统的质量控制与新技术相结合.
- 挑战包括不充分的跨学科合作和缺乏数据治理系统.
- 提出了未来的政策,技术和伦理协同作用的生态系统,以推进药物研究.
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