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

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.

Keywords:

• China
• clinical trial
• drug registration
• review process

Transparency

Declaration of funding

This work was supported by grants from the National Science and Technology Major Project of China: 2020ZX09201-018, 2020ZX09201-017.

Declaration of financial/other relationships

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Yu Cao, Xin Liu and Lianming Liao planned and drafted the paper, and contributed to data quality control, analysis, and interpretation. Hongxia Liu contributed to data quality control and interpretation. Qingshan Zheng provided methodological guidance and support with data interpretation. Yu Cao, Zhongyuan Xu, provided administrative, technical, and material support. Yu Cao, Xin Liu, Zhongyuan Xu, contributed to planning and data interpretation. Yu Cao, Zhongyuan Xu, and Haitao Niu led the overall planning and data interpretation. All authors reviewed and revised the manuscript.

Acknowledgements

None.