Zhao Yi, Du Guiping, Luan Xiaofei, Yang Hui, Zhang Qiongguang, Zhang Zhengfu, Wang Subiao
Women's Hospital, School of Medicine, Zhejiang University, Hangzhou, China.
Device Evaluation Center Zhejiang Medical Products Administration, Hangzhou, China.
Front Pharmacol. 2022 Apr 5;13:850080. doi: 10.3389/fphar.2022.850080. eCollection 2022.
In this study, an investigation was conducted on clinical drug trials comprising pregnant women in China that provided data on the quantity, properties, source of funding, and geographical distribution regarding registration and post-marketing studies. We conducted a cross-sectional descriptive study of clinical trials of pregnant women in China on 30 December 2021, and it was registered on the official Drug Clinical Trial Information Management Platform (ChiCTR) (http://www.chinadrugtrials.org.cn) established by the State Food and Drug Administration of China (Chinese FDA). This study encompassed 72 registered trials (0.46%, 72/15,539) for data analysis. Of these trials, 43.1% of trials were started between 2013 and 2016, and nearly half of the trials (48.6%) were completed. Industries were listed as the primary sponsor for 95.8% trials. Economically developed eastern China and northern China, accounting for 69.5% of the 72 registered trials, were the most frequently identified study locations. Regarding study designs of these trials, more than half of the trials (70.8%) were randomized, 61.1% were a parallel assignment, 33.3% were phase 3, and half of the trials (54.2%) were open label. In total, 23 trials met the requirements after excluding trials of cancer and/or of postmenopausal women, accounting for 0.15% of the 15,539 registered trials in the ChiCTR websites. Of the 72 clinical trials, 54 drugs for 18 indications were included. Of these indications, the highest proportion of the trials is osteoporosis (27.8%), followed by cancer (22.2%), assisted reproduction (13.9%), and other indications (13.9%). This survey revealed a significant shortage of the development, evaluation, and safety trials of pregnancy-related drugs in China. Modifying or adding legislation and providing financial incentives may therefore encourage pharmaceutical companies to conduct additional clinical trials on pregnant women.
在本研究中，对中国涉及孕妇的临床药物试验进行了调查，这些试验提供了有关注册和上市后研究的数量、性质、资金来源及地理分布的数据。我们于2021年12月31日对中国孕妇临床试验进行了横断面描述性研究，并在国家药品监督管理局（中国国家药监局）建立的官方药物临床试验信息管理平台（中国临床试验注册中心，ChiCTR）（http://www.chinadrugtrials.org.cn）上进行了注册。本研究纳入72项注册试验（占0.46%，72/15539）进行数据分析。在这些试验中，43.1%的试验于2013年至2016年启动，近一半的试验（48.6%）已完成。95.8%的试验将企业列为主要申办方。经济发达的中国东部和北部是最常确定的研究地点，占72项注册试验的69.5%。关于这些试验的研究设计，超过一半的试验（70.8%）为随机试验，61.1%为平行分组，33.3%为3期试验，一半的试验（54.2%）为开放标签试验。排除癌症和/或绝经后妇女试验后，共有23项试验符合要求，占中国临床试验注册中心网站15539项注册试验的0.15%。72项临床试验中，涉及18种适应症的54种药物被纳入。在这些适应症中，试验比例最高的是骨质疏松症（27.8%），其次是癌症（22.2%）、辅助生殖（13.9%）和其他适应症（13.9%）。这项调查显示中国与妊娠相关药物的研发、评估和安全性试验严重不足。因此，修改或增加立法并提供财政激励措施可能会鼓励制药公司对孕妇开展更多临床试验。
