Li Shuwen, Li Jianhao, Zeng Wenjing, Li Zhicheng, Zhang Jietong, Wang Siying, Xu Nenggui, Li Zeli
Dongguan Hospital of Guangzhou University of Chinese Medicine, Dongguan Traditional Chinese Medicine Hospital, Dongguan, China.
Clinical Medical College of Acu-Moxi and Rehabilitation, South China Research Center for Acupuncture and Moxibustion, Guangzhou University of Chinese Medicine, Guangzhou, China.
Front Med (Lausanne). 2025 Jan 31;11:1394803. doi: 10.3389/fmed.2024.1394803. eCollection 2024.
To reanalyze and summarize the current status and deficiencies of clinical trial registration in China, based on an analysis of the situation of clinical trial registration in the Chinese Clinical Trial Registry (ChiCTR).
A search was conducted in China National Knowledge Infrastructure (CNKI), Chinese BioMedical Literature Database (CBM), Wangfang Data, VIP Database for Chinese Technical Periodicals (VIP), Web of Science (WoS), PubMed up to December 31, 2023, for literature on the analysis of clinical trial registration based on ChiCTR. NoteExpress software was used for screening, EXCEL for data organization and analysis, the Word Cloud website for constructing word frequency maps, and Origin software for visualization.
Among the 94 articles included, common analysis items included the number of registered projects, types of research, registration time, types of registration institutions, and regional distribution. Most of the included literature was funded. The publishing institutions involved 20 provinces/municipalities across the country, with hospitals being the majority of the publishing units. Most literature was submitted shortly after search completion and published shortly after submission, with more than half of the articles published in high-quality journals. The total average citation count of the literature was 3.34. The sources of clinical trial registration platforms analyzed in the literature were divided into three categories: single platform, dual platform, and multiple platforms.
ChiCTR plays a key role in enhancing transparency in clinical research, promoting standardization and normalization of research, strengthening domestic and international scientific research cooperation, and advancing medical innovation and public health improvement. However, there are still issues with the quality of registration, focus areas, and the evaluation of registration quality.
通过对中国临床试验注册中心（ChiCTR）临床试验注册情况的分析，重新分析并总结我国临床试验注册的现状与不足。
检索中国知网（CNKI）、中国生物医学文献数据库（CBM）、万方数据、维普中文科技期刊数据库（VIP）、Web of Science（WoS）、PubMed截至2023年12月31日的基于ChiCTR的临床试验注册分析文献。使用NoteExpress软件进行筛选，EXCEL进行数据整理与分析，利用词云网站构建词频图，Origin软件进行可视化处理。
纳入的94篇文献中，常见分析项目包括注册项目数量、研究类型、注册时间、注册机构类型及地区分布。纳入文献大多有基金资助。发文机构涉及全国20个省/直辖市，其中医院为主要发文单位。多数文献在检索完成后不久提交，提交后不久发表，超半数文章发表于高质量期刊。文献总平均被引次数为3.34。文献分析的临床试验注册平台来源分为单平台、双平台和多平台三类。
ChiCTR在提高临床研究透明度、促进研究标准化和规范化、加强国内外科研合作以及推动医学创新和改善公众健康方面发挥着关键作用。然而，在注册质量、重点领域以及注册质量评估方面仍存在问题。
