中国临床试验的质量问题：来自质量相关研究的证据。
Quality problems of clinical trials in China: evidence from quality related studies.
作者信息
Fan Jin, Liu Xiaobo, Li Yuxi, Xia Haisha, Yang Rong, Li Juan, Zhang Yonggang
机构信息
Department of Periodical Press, National Clinical Research Center for Geriatrics, West China Hospital, Sichuan University, Chengdu, China.
School of Health Preservation and Rehabilitation, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
出版信息
Trials. 2022 Apr 23;23(1):343. doi: 10.1186/s13063-022-06281-1.
BACKGROUND
Recently, the quality of clinical trials conducted in China has made considerable progress. However, clinical trials conducted in China still fall below the global average standard. The aim of this systematic review was to assess studies that investigated the quality of clinical trials conducted in China, summarize the issues, and provide suggestions for conducting high-quality clinical trials in China.
METHODS
We comprehensively searched studies that investigated the quality of clinical trials conducted in China in the following databases from inception to December 1, 2021: National Knowledge Infrastructure, the Chinese Science and Technology Periodical Database, WanFang Data, China Biology Medicine, PubMed, and Embase. We then analyzed the issues in clinical trial registration, ethics review, implementation, and reporting. SPSS 25.0 software was used for data analysis. The data synthesis was conducted using summary statistics and a narrative format.
RESULTS
A total of 90 studies were analyzed, there were 50 studies with 0-5 citation counts (55.56%), 18 studies with 5-10 citation counts (20%), 9 studies with 10-15 citation counts (10%), and 13 studies with more than 15 citation counts (14.44%). Eight (8.89%) studies were conducted by a supervision department, 38 (42.22%) by organizations with GCP qualification, and 44 (48.89%) by third parties. Additionally, there were some problems in the ethical review process of clinical trials, clinical trial registration process, clinical trial implementation process, and clinical trial reporting process.
CONCLUSIONS
The current study shows that the quality problems of clinical trials in China still exist. The reported problems are related to the process of clinical trials, including ethical review, registration, implementation, reporting. Due to the limited quantity and quality of included studies, the conclusions of this study need to be verified by high-quality studies.
REVIEW REGISTRATION
Not registerated in PROSPERO.
背景
近年来，中国开展的临床试验质量取得了长足进步。然而，中国开展的临床试验仍低于全球平均标准。本系统评价的目的是评估调查中国开展的临床试验质量的研究，总结问题，并为在中国开展高质量临床试验提供建议。
方法
我们全面检索了从建库至2021年12月1日在以下数据库中调查中国开展的临床试验质量的研究：中国知网、维普中文科技期刊数据库、万方数据、中国生物医学文献数据库、PubMed和Embase。然后我们分析了临床试验注册、伦理审查、实施和报告方面的问题。使用SPSS 25.0软件进行数据分析。采用汇总统计和叙述性格式进行数据合成。
结果
共分析了90项研究，其中被引频次为0 - 5次的有50项研究（55.56%），5 - 10次的有18项研究（20%），10 - 15次的有9项研究（10%），超过15次的有13项研究（14.44%）。8项研究（8.89%）由监管部门开展，38项研究（42.22%）由具有药物临床试验质量管理规范（GCP）资质的机构开展，44项研究（48.89%）由第三方开展。此外，临床试验伦理审查过程、临床试验注册过程、临床试验实施过程和临床试验报告过程中均存在一些问题。
结论
当前研究表明，中国临床试验的质量问题仍然存在。报告的问题与临床试验过程相关，包括伦理审查、注册、实施、报告。由于纳入研究的数量和质量有限，本研究的结论需要通过高质量研究进行验证。
综述注册
未在国际前瞻性系统评价注册库（PROSPERO）注册。
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