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
Review
. 2021 Apr;9(2):e00729.
doi: 10.1002/prp2.729.

Changes in clinical trials of endocrine disorder and metabolism and nutrition disorder drugs in mainland China over 2010-2019

Xin Liu  1 , Suqin Wu  2 , Jian Sun  3 , Suiqin Ni  4 , Laichun Lu  5 , Wei Hu  6 , Hua Wei  7 , Yanqin Zou  8 , Ting Li  9 , Jintong Li  10 , Bugela Mijiti  11 , PingFei Fang  12 , Limei Zhao  13 , Huan Zhou  14 , Xiaoming Xing  15 , Haitao Niu  15 , Yu Cao  15
Affiliations
Review

Changes in clinical trials of endocrine disorder and metabolism and nutrition disorder drugs in mainland China over 2010-2019

Xin Liu et al. Pharmacol Res Perspect. 2021 Apr.

Abstract

With the improvements in relevant policies, laws, and regulations regarding drug clinical trials in China, the quantity and quality of drug clinical trials have gradually improved, and the development prospects of drug clinical trials for endocrine disorders and metabolism and nutrition disorders are promising. Based on information from the clinical trials from the online drug clinical trial registration platform of the National Medical Products Administration, we aimed to review and evaluate the development of clinical trials of drugs for endocrine disorders and metabolism and nutrition disorders in mainland China from 2010 to 2019, as well as the trends over time. A total of 861 trials were carried out on 254 types of drugs for endocrine disorders and metabolism and nutrition disorders, among which 531 (61.67%) involved endocrine disorders, and 330 (38.33%) addressed metabolism and nutrition disorders. The annual number of clinical trials has been increasing gradually, with a significant increase in 2017. Among them, the proportion of clinical trials with Chinese epidemiological characteristics was relatively large (Wu, Annual Report on Development Health Management and Health Industry in China, 2018). The largest number of trials were for diabetes drugs (55.63%), followed by trials of drugs for hyperlipidemia (19.4%) and those for hyperuricemia (7.9%). It was found that the geographical area of the leading units also showed obvious unevenness according to the analysis of the test unit data. Based on the statistics and evaluation of the data, comprehensive information is provided to support the cooperation of global pharmaceutical R&D companies and research units in China and the development of international multicenter clinical trials in China. This work additionally provides clinical trial units with a self-evaluation of scientific research competitiveness and hospital development strategies. At the same time, it provides a reference with basic data for sponsors and stakeholders in these trials to determine their development strategy goals.

Keywords: China; clinical trial; endocrine disorder; metabolism and nutrition disorder.

PubMed Disclaimer

Conflict of interest statement

No.

Figures

FIGURE 1
FIGURE 1
Number of endocrine disorder and metabolism and nutrition disorder drug trials from 2010 to 2019 in China
FIGURE 2
FIGURE 2
Number of endocrine disorder and metabolism and nutrition disorder drug trials in different phases from 2010 to 2019 in China
FIGURE 3
FIGURE 3
Number of trials classified by indication from 2010 to 2019 in China
FIGURE 4
FIGURE 4
Number of diabetes drug trials from 2010 to 2019 in China
FIGURE 5
FIGURE 5
Number of clinical trials of the top five drugs for hypoglycemic mechanisms from 2010 to 2019 in China
See this image and copyright information in PMC

Similar articles

See all similar articles

Cited by

References

    1. Wu LX. Annual Report on Development Health Management and Health Industry in China. Beijing: Zhongguancun Xinzhiyuan Health Management Institute, Central South University Health Management Research Center and Social Sciences Academic Press; 2018.
    1. Liu M, Liu S‐W, Wang L‐J, et al. Burden of diabetes, hyperglycaemia in China from to 2016: findings from the 1990 to 2016, global burden of disease study. Diabetes Metab. 2019;45(3):286‐293. - PubMed
    1. Zhao S, Lv C, Gong JF, et al. Challenges in anticancer drug R&D in China. Lancet Oncol. 2019;20(2):183‐186. - PubMed
    1. Wang M. Clinical trials and drug approvals continue to accelerate in China. Lancet Oncol. 2017;18(7):855. - PubMed
    1. Zhou Q, Chen X‐Y, Yang Z‐M, et al. The changing landscape of clinical trial and approval processes in China. Nat Rev Clin Oncol. 2017;14(9):577‐583. - PubMed

MeSH terms

LinkOut - more resources