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2009 年至 2020 年中国大陆药物临床试验趋势。

Trend of drug clinical trials in mainland China from 2009 to 2020.

机构信息

Clinical Trials Center, The Affiliated Hospital of Qingdao University, Qingdao, Shandong, China.

Center of Laboratory Medicine, Fujian Medical University Union Hospital, Fuzhou, Fujian, China.

出版信息

Curr Med Res Opin. 2022 Sep;38(9):1499-1507. doi: 10.1080/03007995.2022.2103960. Epub 2022 Jul 29.

Abstract

With the development of linnovative regulations on drug clinical trials in mainland China, the quantity and quality of drug clinical trials have gradually improved over the past decade. Based on the information of the clinical trials from the online drug clinical trial registration platform of National Medical Products Administration, we reviewed the data of drug clinical trials in mainland China from 2009 to 2020. A total of 8,593 clinical trials have been conducted during this period. The annual number of clinical trials has been increasing gradually, and peaked in 2017. There were 2,127, 1,051, 1,551, and 156 phases I, II, III, and IV clinical trials respectively. In addition, there were 3,441 bioequivalence studies. Trials for anti-tumor drugs ranked the highest (19.45%), followed by trials of drugs for infections and infestations (12.96%) and those for cardiovascular diseases (9.00%). Meanwhile the number of the clinical trial sites also increased annually. However, there were only 116 and 130 clinical trials of drugs for children and rare diseases respectively. The geographical distribution of the sites was uneven. This mapping review provides an overall look of clinical trials in China, which may be useful for domestic and international sponsors.

摘要

随着中国内地创新药物临床试验法规的发展,过去十年中药物临床试验的数量和质量逐渐提高。我们基于国家药品监督管理局在线药物临床试验登记平台的临床试验信息,回顾了 2009 年至 2020 年中国内地的药物临床试验数据。在此期间共开展了 8593 项临床试验。临床试验的年数量逐渐增加,并在 2017 年达到峰值。分别有 2127、1051、1551 和 156 项 I、II、III 和 IV 期临床试验,此外还有 3441 项生物等效性研究。抗肿瘤药物的试验数量最高(19.45%),其次是感染和寄生虫病药物(12.96%)和心血管疾病药物(9.00%)。同时,临床试验点的数量也逐年增加。然而,儿童和罕见病药物的临床试验分别仅有 116 项和 130 项。试验点的地理分布不均。本图谱回顾提供了中国临床试验的全貌,这可能对国内外申办者有用。

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