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Changes in Early-Phase Clinical Trials in China During 2013-2022: A Review
Jianxiong Zhang1, Peng Zhang2, Haixue Wang3
1Research Ward, Beijing Friendship Hospital, Capital Medical University, Beijing, China.
Drugs in R&D
|September 12, 2024
Summary
China
Area of Science:
- Pharmaceutical Science
- Clinical Research
- Drug Development
Background:
- China's pharmaceutical industry is experiencing rapid growth in innovative drug clinical trials.
- Government policies have significantly boosted research and development enthusiasm.
- Early-phase clinical trial data from the Chinese Center for Drug Evaluation (CDE) from 2013-2022 was analyzed.
Purpose of the Study:
- To analyze the trends and characteristics of early-phase clinical trials in China.
- To assess the impact of government policies on drug development.
- To identify key areas for future improvement in clinical trial efficiency.
Main Methods:
- Data from 5336 early-phase clinical trials registered with the CDE were summarized.
- Analysis included trial registration time, drug classification, indications, and trial status.
- Trends in trial quantity, growth rate, drug types, and therapeutic areas were examined.
Main Results:
- A substantial year-on-year increase in the quantity and growth rate of early-phase clinical trials.
- Chemical drugs dominated trials but decreased from 85.7% in 2013 to 59.5% in 2022.
- Oncology drugs showed a significant yearly increase, reaching 49.2% of trials in 2022.
Conclusions:
- Early-phase clinical trial development in China has progressed significantly between 2013-2022, driven by government support and advanced techniques.
- Continued progress necessitates advanced technical support and enhanced standardized supervision systems.
- The rise in oncology drug trials highlights a key focus area for future pharmaceutical innovation.
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