Namiot Eugenia D, Smirnovová Diana, Sokolov Aleksandr V, Chubarev Vladimir N, Tarasov Vadim V, Schiöth Helgi B
Department of Surgical Sciences, Division of Functional Pharmacology and Neuroscience, Uppsala University, Uppsala, Sweden.
Advanced Molecular Technology, Limited Liable Company (LLC), Moscow, Russia.
Front Pharmacol. 2023 Sep 18;14:1228148. doi: 10.3389/fphar.2023.1228148. eCollection 2023.
Clinical trials are the gold standard for testing new therapies. Databases like ClinicalTrials.gov provide access to trial information, mainly covering the US and Europe. In 2006, WHO introduced the global ICTRP, aggregating data from ClinicalTrials.gov and 17 other national registers, making it the largest clinical trial platform by June 2019. This study conducts a comprehensive global analysis of the ICTRP database and provides framework for large-scale data analysis, data preparation, curation, and filtering. The trends in 689,793 records from the ICTRP database (covering trials registered from 1990 to 2020) were analyzed. Records were adjusted for duplicates and mapping of agents to drug classes was performed. Several databases, including DrugBank, MESH, and the NIH Drug Information Portal were used to investigate trends in agent classes. Our novel approach unveiled that 0.5% of the trials we identified were hidden duplicates, primarily originating from the EUCTR database, which accounted for 82.9% of these duplicates. However, the overall number of hidden duplicates within the ICTRP seems to be decreasing. In total, 689 793 trials (478 345 interventional) were registered in the ICTRP between 1990 and 2020, surpassing the count of trials in ClinicalTrials.gov (362 500 trials by the end of 2020). We identified 4 865 unique agents in trials with DrugBank, whereas 2 633 agents were identified with NIH Drug Information Portal data. After the ClinicalTrials.gov, EUCTR had the most trials in the ICTRP, followed by CTRI, IRCT, CHiCTR, and ISRCTN. CHiCTR displayed a significant surge in trial registration around 2015, while CTRI experienced rapid growth starting in 2016. This study highlights both the strengths and weaknesses of using the ICTRP as a data source for analyzing trends in clinical trials, and emphasizes the value of utilizing multiple registries for a comprehensive analysis.
临床试验是测试新疗法的金标准。像ClinicalTrials.gov这样的数据库提供试验信息的访问,主要覆盖美国和欧洲。2006年,世界卫生组织推出了全球国际临床试验注册平台(ICTRP),汇总了ClinicalTrials.gov和其他17个国家注册机构的数据,使其在2019年6月成为最大的临床试验平台。本研究对ICTRP数据库进行了全面的全球分析,并为大规模数据分析、数据准备、管理和筛选提供了框架。分析了ICTRP数据库中689,793条记录的趋势(涵盖1990年至2020年注册的试验)。对记录进行了重复项调整,并对药物进行了药物类别映射。使用了几个数据库,包括DrugBank、医学主题词表(MESH)和美国国立卫生研究院药物信息门户,来研究药物类别的趋势。我们的新方法揭示,我们识别出的试验中有0.5%是隐藏的重复项,主要源自欧盟临床试验注册数据库(EUCTR),该数据库占这些重复项的82.9%。然而,ICTRP中隐藏重复项的总数似乎在减少。1990年至2020年期间,ICTRP总共注册了689793项试验(478345项干预性试验),超过了ClinicalTrials.gov中的试验数量(截至2020年底为362500项试验)。我们在使用DrugBank的试验中识别出4865种独特的药物,而使用美国国立卫生研究院药物信息门户数据识别出2633种药物。在ClinicalTrials.gov之后,EUCTR在ICTRP中的试验最多,其次是印度临床试验注册平台(CTRI)、伊朗临床试验注册中心(IRCT)、中国临床试验注册中心(CHiCTR)和国际标准随机对照试验编号注册库(ISRCTN)。CHiCTR在2015年左右试验注册量显著激增,而CTRI从2016年开始经历快速增长。本研究突出了将ICTRP用作分析临床试验趋势数据源的优势和劣势,并强调了利用多个注册机构进行全面分析的价值。