Trends of Phase I Clinical Trials of New Drugs in Mainland China Over the Past 10 Years (2011–2020)

作者：Chen Chen, Ning Lou, Xin Zheng, Shasha Wang, Haizhu Chen, Xiaohong Han · 发表于：Frontiers in Medicine · 年份：2021 · DOI：10.3389/fmed.2021.777698 · 被引用次数：20 · 研究领域：Health and Medical Research Impacts、Ethics in Clinical Research、Meta-analysis and systematic reviews

Background: In recent years, the number of clinical trials initiated in China has increased rapidly. The aim of this study was to overview the changing landscape of phase I clinical trials in mainland China from 2011 to 2020. Methods: We analyzed phase I clinical trials registered on 3 websites including the Chinese Clinical Trial Registry, ClinicalTrials.gov , and the China National Medical Products Administration Center for Drug Evaluation platform. Findings: A total of 2,842 phase I clinical trials were posted from January 1, 2011, to December 31, 2020. The overall number of clinical trials for innovative drugs was 1,497, accounting for half of all the phase I clinical trials (53%). Among these 1,486 innovative drug clinical trials, 924 were newly tested drugs with an average annual growth rate of 59%. Biological drug research increased significantly from 22.6% during 2011–2015 to 33.3% during 2016–2020. These principal investigators (PIs) of these clinical trials were mainly from Beijing ( n = 871), followed by Shanghai ( n = 496) and Jiangsu ( n = 281). As for the therapeutic area of phase I clinical trials, cancer took up the most percentage of all the clinical trials (35%), followed by infectious disease (9%), nervous system disease (9%), etc. Most phase I clinical trials are conducted on healthy volunteers ( n = 1,642, 57.8%), some cancer drugs are conducted in patients with cancer ( n = 846, 29.8%), and only a few clinical trials were conducted in the elderly ( n = 7...