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ORIGINAL RESEARCH article
Front. Med.
Sec. Regulatory Science
Volume 11 - 2024 |
doi: 10.3389/fmed.2024.1394803
This article is part of the Research Topic The Integrity of Randomized Clinical Trials View all 4 articles
Re-analysis of the Current Status of Clinical Trial Registration in China
Provisionally accepted- 1 Clinical School of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China
- 2 South China Research Center for Acupuncture and Moxibustion, Medical College of Acu-Moxi and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, Guangdong, China
- 3 Beijing University of Chinese Medicine, Beijing, Beijing Municipality, China
- 4 Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing, Beijing Municipality, China
- 5 Guangzhou University of Chinese Medicine, Guangzhou, Guangdong Province, China
OBJECTIVE: 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). METHODS: A search was conducted in CNKI (China National Knowledge Infrastructure), CBM (Chinese BioMedical Literature Database), Wangfang Data, VIP (VIP Database for Chinese Technical Periodicals), WoS (Web of Science), 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. RESULTS: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. CONCLUSION: 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.
Keywords: Current State of Registration, Chinese Clinical Trial Registry, Evaluation of Registration Quality, Re-analysis, Insufficiency
Received: 23 Mar 2024; Accepted: 21 Nov 2024.
Copyright: © 2024 Zeli, Shuwen, Weiheng, zhicheng, Jietong, Siying, Xu and Dongfeng. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence:
Li Zeli, Clinical School of Acupuncture, Moxibustion and Rehabilitation, Guangzhou University of Chinese Medicine, Guangzhou, China
Chen Weiheng, Beijing University of Chinese Medicine Third Affiliated Hospital, Beijing, 100029, Beijing Municipality, China
Li zhicheng, Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, China
Zhang Jietong, Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, China
Wang Siying, Guangzhou University of Chinese Medicine, Guangzhou, 510006, Guangdong Province, China
Du Dongfeng, Beijing University of Chinese Medicine, Beijing, 100029, Beijing Municipality, China
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