Li Xiaodan, Zhang Shengzhao, Zhou Yiling, Liu Ying, Zhou Youlian, Li Sheyu, Su Na
Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.
Department of Pharmacy, West China Hospital, Sichuan University, Chengdu, China.
Front Med (Lausanne). 2021 Mar 31;8:618185. doi: 10.3389/fmed.2021.618185. eCollection 2021.
The coronavirus disease 2019 (COVID-19) pandemic has affected the world since late 2019. The efforts to control the spread of the virus need to be supported by credible evidence. Therefore, we analyzed the rationality of the timeline and geographic distribution of COVID-19 trial registration in mainland China. We searched the Chinese Clinical Trial Registry (ChiCTR, http://www.chictr.org.cn/) and International Clinical Trials Registry Platform (ICTRP, https://www.who.int/ictrp/en/) using keywords including novel coronavirus, coronavirus pneumonia, 2019-nCoV, COVID-19, and SARS-COV-2 from 1 December 2019 to 27 April 2020 and included interventional randomized and non-randomized trials including patients with confirmed cases of COVID-19 in mainland China. The registered trials were reviewed, and data were independently extracted by two reviewers based on the inclusion criteria. A total of 263 registered interventional trials were included in the study. We defined the sample size index (SI) as the total number of patients needed by the trials divided by the total number of patients diagnosed with COVID-19. A total of 84,341 patients had been diagnosed with COVID-19 in China as of 26 April 2020, and the included trials had a combined sample size of 31,156 patients (SI: 0.37). After control of the COVID-19 epidemic was achieved in China (February 18, 2020), the SI was 1.54, suggesting that the number of patients needed by the trials was greater than the number of newly diagnosed patients. The SIs in 8 out of 26 provinces in mainland China were >1. Our results suggested a clear over registration of COVID-19 trials in China, especially after control of the pandemic was achieved, preventing the generation of high-quality evidence.
自2019年末以来，2019冠状病毒病（COVID-19）大流行已对全球造成影响。控制病毒传播的努力需要可靠证据的支持。因此，我们分析了中国大陆COVID-19试验注册时间线和地理分布的合理性。我们使用包括新型冠状病毒、冠状病毒肺炎、2019-nCoV、COVID-19和SARS-CoV-2等关键词，在2019年12月1日至2020年4月27日期间检索了中国临床试验注册中心（ChiCTR，http://www.chictr.org.cn/）和国际临床试验注册平台（ICTRP，https://www.who.int/ictrp/en/），纳入了中国大陆COVID-19确诊病例患者的干预性随机和非随机试验。对注册试验进行了审查，两名审阅者根据纳入标准独立提取数据。本研究共纳入263项注册干预试验。我们将样本量指数（SI）定义为试验所需患者总数除以COVID-19确诊患者总数。截至2020年4月26日，中国共有84341例患者被诊断为COVID-19，纳入试验的合并样本量为31156例患者（SI：0.37）。在中国实现COVID-19疫情控制后（2020年2月18日），SI为1.54，这表明试验所需患者数量大于新确诊患者数量。中国大陆26个省份中有8个省份的SI>1。我们的结果表明，中国COVID-19试验存在明显的过度注册情况，尤其是在疫情得到控制之后，这阻碍了高质量证据的产生。
