Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2021 Oct 4:8:745676.
doi: 10.3389/fmed.2021.745676. eCollection 2021.

Pediatric Clinical Trials in Mainland China Over the Past Decade (From 2009 to 2020)

Wen-Wen Wu  1 , Xing Ji  1 , Hao Wang  2 , Feng Chen  1 , Qian Ding  3 , Guan-Dong Zhang  4 , Man Li  1 , Shan-Shan Wang  1 , Ming-Ming Ni  1 , Qing-Qing Liu  1 , Jing Xu  1 , Qian Wang  1
Affiliations

Pediatric Clinical Trials in Mainland China Over the Past Decade (From 2009 to 2020)

Wen-Wen Wu et al. Front Med (Lausanne). .

Abstract

In mainland China, there remains a shortage of pediatric drugs. The Chinese government has recently launched policies and incentives to encourage pediatric drug development and clinical trials. However, data on the characteristics or development trends of these trials are limited. In this review, we extracted source data from the Chinese Clinical Trials Registry and Information Transparency Platform and systematically reviewed the pediatric clinical trials conducted in mainland China from 2009 to 2020, a comprehensive process evaluation of the pediatric drug clinical trials development in the past decade, providing data support to policy makers and industry stakeholders. We included 487 pediatric clinical trials. Over the past decade, the number of pediatric trials has increased, especially since 2016. The most common therapeutic areas were infectious diseases (n = 108, 22.2%), agents for preventive purpose (n = 99, 20.3%), and neurological and psychiatric diseases (n = 71, 14.6%). The number of clinical trials involving epilepsy (39, 10.1%), asthma (33, 8.5%), and influenza (24, 6.2%) were the highest. The distribution of leading institutions is unbalanced in mainland China, with most units in East China (34.0%) and few in Southwest China (6.9%). China has made progress in improving the research and development environment of pediatric drugs and increasing pediatric trials. However, a wide gap in pediatric drug development and clinical trials quality exists between China and the developed countries. The pharmaceutical industry in China has faced grim setbacks, including study duplication, lack of innovation, poor research design, and unbalanced resource allocation. Thus, we suggest that the Chinese government should adjust their policies to improve innovation and clinical design capacity, and optimize resource allocation between regions.

Keywords: Chinese Clinical Trials Registry and Information Transparency Platform; National Medical Products Administration; drug research and development; pediatric clinical trials; pediatric population.

PubMed Disclaimer

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Strategy of retrieval and selection of pediatric clinical trials.
Figure 2
Figure 2
Distribution of pediatric clinical trials by classification of study phases (A) and drug type (B).
Figure 3
Figure 3
Number and initial time of pediatric clinical trials by drug type (A) and study phase (B).
Figure 4
Figure 4
Distribution of pediatric clinical trials by age group.
Figure 5
Figure 5
Distribution of pediatric clinical trials by disease system.
Figure 6
Figure 6
Distribution of chemical drugs by registration classification in pediatric clinical trials.
Figure 7
Figure 7
Distribution of domestic and imported chemical drugs in pediatric clinical trials.
Figure 8
Figure 8
Development trends of different types of chemical drugs in pediatric clinical trials.
Figure 9
Figure 9
Sponsorship of pediatric clinical trials.
Figure 10
Figure 10
Distribution of leading unit institutions in mainland China.
Figure 11
Figure 11
Policies and regulations.
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. White Paper on the Investigation of Pediatric Drug Use Safety . (2016). Available online at: https://www.ruiwen.com/gongwen/diaochabaogao/99076.html (accessed April 30, 2020).
    1. Li J, Yan K, Kong YT, Ye XF, Ge MM, Zhang CF. A cross-sectional study of children clinical trials registration in the world based on ClinicalTrials.gov establishment. Chin J Evid Based Pediatr. (2016) 11:3–7. 10.3969/j.issn.1673-5501.2016.01.002 - DOI
    1. Zhang GD, Yang Y, Zhao RL. Characteristics Analysis of Pediatric Drug Clinical Trials Registered in Chinese Clinical Trial Registry. China Pharmacy. (2020) 31:2055–60. 10.6039/j.issn.1001-0408.2020.17.02 - DOI
    1. Hao GX, Yuan XX, Guo W, Quan XY, Qi XJ, Wang TY, Zhao W. Paediatric drugs trials in China. BMJ Paediatrics Open. (2020) 4:e000618. 10.1136/bmjpo-2019-000618 - DOI - PMC - PubMed
    1. National Health Commission of the People's Republic of China . Chinese National Formulary. (2010). Available online at: http://www.nhc.gov.cn/cms-search/xxgk/getManuscriptXxgk.htm?id=45875 (accessed April 30, 2020).

Publication types