TIAN Min 1,2,3,4 , ZHENG Qingyong 2,3 , WEN Shiqi 5 , HAN Xue 5 , XU Zhuoxin 6 , GAO Bei 1,4 , LEI Wenjuan 1,4 , DU Li 7 , GE Bin 1,4 , MENG Min 2,3,4,8 , TIAN Jinhui 2,3
  • 1. Department of Pharmacy, Gansu Provincial Hospital, Lanzhou 730000, P. R. China;
  • 2. Evidence-Based Medicine Center, School of Basic Medical Sciences, Lanzhou University, Lanzhou 730000, P. R. China;
  • 3. Key Laboratory of Evidence-Based Medicine of Gansu Province, Lanzhou 730000, P. R. China;
  • 4. Gansu Provincial Clinical Comprehensive Evaluation Technology Center for Pharmaceuticals, Gansu Provincial Health Commission, Lanzhou 730000, P. R. China;
  • 5. The First School of Clinical Medicine, Lanzhou University, Lanzhou 730000, P. R. China;
  • 6. College of Pharmacy, Gansu University of Chinese Medicine, Lanzhou 730000, P. R. China;
  • 7. The Third People's Hospital of Lanzhou, Lanzhou 730000, P. R. China;
  • 8. Department of Medical, Gansu Provincial Hospital, Lanzhou 730000, P. R. China;
MENG Min, Email: min_pharmacy@163.com; TIAN Jinhui, Email: tjh996@163.com
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Objective To review the current status of case studies on drug comprehensive clinical evaluation published in China in the past decade, providing references for the standardized implementation of evaluation. Methods A scoping review was conducted on the published cases of drug comprehensive clinical evaluation in China. The analysis was carried out from themes, dimensions, methods, and quality control. Descriptive analysis was used to analyze the evaluation themes, dimension, method, and quality control of the included studies. Meanwhile, VOSviewer 1.6.20 software was used to conduct co-occurrence network analysis of author's affiliation and evaluation dimensions. Results The research on comprehensive drug clinical evaluation has developed the fastest in Beijing. Medical institutions, universities, and scientific institutions are the main research institutions. Universities and their affiliated hospitals have stronger collaboration, while some local hospitals show research isolation. The evaluation themes focus on chronic diseases and cancer, with some repetitions. The evaluation methods mainly rely on descriptive analysis. In nearly half of the cases, evidence-based medicine methods are inadequately applied. Only about 5% of the cases have conducted real-world research. For cases with the same theme, results may conflict due to differences in methods or data sources. The value integration mainly relies on quantitative scoring, which is lacking in 37.05% cases. Only 14.03% of the cases report quality control. In 31.87% of cases, the data provided by pharmaceutical companies were used, with a lack of conflict-of-interest disclosures. Conclusion Although the comprehensive clinical evaluation of drugs in China has developed rapidly, there are problems such as non-standardized methods and differences in data sources. It is necessary to improve the scientificity and decision-making value of evaluation results by coordinating theme selection, strengthening quality control, and developing reporting guideline.

Citation: TIAN Min, ZHENG Qingyong, WEN Shiqi, HAN Xue, XU Zhuoxin, GAO Bei, LEI Wenjuan, DU Li, GE Bin, MENG Min, TIAN Jinhui. The current situation of comprehensive clinical evaluation cases of drugs in China. Chinese Journal of Evidence-Based Medicine, 2026, 26(7): 827-833. doi: 10.7507/1672-2531.202508013 Copy

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