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. 2022 Aug;28(8):1229-1239.
doi: 10.1111/cns.13867. Epub 2022 Jun 1.

Evolution of ischemic stroke drug clinical trials in mainland China from 2005 to 2021

Chunrui Bo  1   2 , Tianqi Wang  1 , Chengbei Hou  3 , Jinming Han  1 , Lixia Chen  2 , Huixue Zhang  2 , Lihua Wang  2 , Hongyan Li  4
Affiliations

Evolution of ischemic stroke drug clinical trials in mainland China from 2005 to 2021

Chunrui Bo et al. CNS Neurosci Ther. 2022 Aug.

Abstract

Background: To assess the temporal changes in the characteristics of ischemic stroke drug clinical trials conducted in mainland China in 2005-2021.

Methods: A statistical analysis of registered clinical trials on ischemic stroke was performed using the platform of the Center for Drug Evaluation of China National Medical Products Administration, the Chinese Clinical Trial Registry, and ClinicalTrials.gov websites.

Results: From January 1, 2005 to August 1, 2021, a total of 384 registered drug clinical trials on ischemic stroke were identified in mainland China. Over time, the number of trials gradually increased each year, with a significant growth in 2014, from 16 in 2013 to 42 in 2014. Phase IV trials (31.8%) accounted for the majority, followed by phase II (16.4%), phase I (10.9%), and phase III (8.6%). In terms of sponsorship, the proportion of investigator-initiated trials (IITs) (60.7%) was higher than industry-sponsored trials (ISTs) (39.3%). Additionally, trials involving traditional Chinese medicines (TCMs) (36.2%) accounted for the largest proportion, followed by trials involving antithrombotic therapy (19.5%) and cerebral protection agents (16.7%). Furthermore, over the past 17 years, the number of leading drug clinical trial units for ischemic stroke in mainland China has continuously increased. The leading principal units from Beijing, Shanghai, Guangdong, Jiangsu, and Liaoning accounted for the majority of the trials (67.4%).

Conclusion: In the past 17 years, great progress has been made in the research and development (R&D) of drugs and clinical trials for ischemic stroke in mainland China. The most extensive progress was observed in TCMs, antithrombotic therapy, and cerebral protection agents. More clinical trials are needed to confirm whether the newly developed drugs can improve the clinical efficacy of ischemic stroke. Simultaneously, more pharmaceutical R&D efforts of innovative drugs are warranted.

Keywords: drug clinical trials; ischemic stroke; mainland China.

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Conflict of interest statement

The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

FIGURE 1
FIGURE 1
Selection procedure of drug clinical trials for ischemic stroke using three registration platforms
FIGURE 2
FIGURE 2
Annual number of clinical trials of ischemic stroke drugs conducted in mainland China based on study phase from 2005 to 2021
FIGURE 3
FIGURE 3
Annual number of ischemic stroke drug clinical trials based on sponsorship in mainland China from 2005 to 2021
FIGURE 4
FIGURE 4
The proportion of newly tested drugs from ISTs during 2005–2021
FIGURE 5
FIGURE 5
Annual number of newly tested ischemic stroke drugs in ISTs from 2005 to 2021
FIGURE 6
FIGURE 6
Distribution of clinical trials based on drug type or mechanism of action in mainland China between 2005 and 2021. (A) Overview of clinical trials based on drug type. (B) Distribution of antithrombotic therapeutic trials. (C) Distribution of drug trials on controlling risk factors. (D) Distribution of drug trials for improving cerebral circulation. (E) Distribution of trials involving others, including immunomodulating drugs, cellular anti‐ischemic drugs, dehydrant agents, sedative drugs, psychotropic medication, anticholinergic drugs, non‐steroidal anti‐inflammatory drugs (NSAIDs), and four drugs that cannot be categorized. (F) Distribution of trials involving traditional Chinese medicines (TCMs)
FIGURE 7
FIGURE 7
Geographical distribution of trials according to provinces or municipalities that participated in across mainland China in 2005–2021
FIGURE 8
FIGURE 8
Geographical distribution of drug trials based on Chinese provinces or municipalities of the principal investigator from 2005 to 2021
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