重新分析中国临床试验注册的现状
Shuwen Li1,2, Jianhao Li3, Wenjing Zeng2
1Dongguan Hospital of Guangzhou University of Chinese Medicine, Dongguan Traditional Chinese Medicine Hospital, Dongguan, China.
Frontiers in medicine
|February 17, 2025
概括
本研究分析了通过中国临床试验注册局 (ChiCTR) 在中国进行的临床试验注册. 虽然ChiCTR提高了研究透明度和合作,但仍然存在注册质量和重点领域的问题.
科学领域:
- 临床研究 临床研究
- 医疗保健服务研究 医疗服务研究
- 生物医学信息学 生物医学信息学
背景情况:
- 临床试验注册对于研究的完整性和透明度至关重要.
- 中国临床试验注册 (ChiCTR) 是中国临床试验注册的主要平台.
- 了解中国临床试验注册的现状和缺陷对于提高研究质量至关重要.
研究的目的:
- 重新分析和总结中国临床试验注册的现状.
- 根据对中国临床试验注册表 (ChiCTR) 的分析,确定临床试验注册的缺陷.
主要方法:
- 在多个数据库 (CNKI,CBM,Wangfang,VIP,WoS,PubMed) 进行了全面的文献搜索,截至2023年12月31日.
- 使用NoteExpress,EXCEL,Word云和Origin软件进行选,数据组织,可视化和分析.
- 这项研究包括了94篇分析基于ChiCTR的临床试验注册的文章.
主要成果:
- 通常分析的项目包括项目号码,研究类型,注册时间,机构类型和区域分布.
- 大多数分析的文献是资助的,医院是20个省份的主要出版单位.
- 大多数研究在提交后不久就在优质期刊上发表,平均引用数为3.34.
结论:
- 中国临床试验注册局 (ChiCTR) 显著提高了临床研究的透明度,标准化和国际合作.
- 尽管它发挥着重要作用,但在注册质量,具体重点领域以及注册质量的评估方面仍然存在挑战.
- 解决这些缺陷对于推动中国医疗创新和公共卫生至关重要.
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