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Analysis and intervention strategies for 528 cases of serious adverse events in tumor drug clinical trials based on ethical review
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Shu-hao KOU1, 2, 3, 4, Qin XIAO1, 3, Ya-ting LIU1, 2, 3, 4, Pei-jun XIAO1, 3, Yan-hong LUO1, 3, Jia ZHOU1, 2, 3, 4, Bin-yu ZENG1, 2, 3, 4, Qun QIN1, 2, 3, 4, Xin ZHANG1, 3
Chinese Journal of Clinical Pharmacology | 2025, 41(20) : 2976 - 2981
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Chinese Journal of Clinical Pharmacology | 2025, 41(20): 2976-2981
• Special Column of Clinical Trials Administration •
Analysis and intervention strategies for 528 cases of serious adverse events in tumor drug clinical trials based on ethical review
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Shu-hao KOU1, 2, 3, 4, Qin XIAO1, 3, Ya-ting LIU1, 2, 3, 4, Pei-jun XIAO1, 3, Yan-hong LUO1, 3, Jia ZHOU1, 2, 3, 4, Bin-yu ZENG1, 2, 3, 4, Qun QIN1, 2, 3, 4, Xin ZHANG1, 3
Affiliations
  • 1.Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
  • 2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
  • 3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
  • 4.Hunan Provincial International Science and Technology Innovation Cooperation Base for Early Clinical Trials of Biological Products, Changsha 410008, Hunan Province, China
Published: 2025-10-28 doi: 10.13699/j.cnki.1001-6821.2025.20.021
Outline
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Objective

To track and follow up serious adverse event (SAE) occurring at a tertiary hospital clinical trial institution in Hunan province, analyze and summarize the occurrence and outcomes of SAEs, and propose interventions and improvement measures to standardize the handling of SAE, report them promptly, protect the safety of research participants, ensure the reliability of clinical trial data, and improve the level of clinical trials.

Methods

A total of 528 SAEs related to cancer drugs were collected from this clinical trial institution from January 2020 to December 2024 and analyzed using SPSS 25.0 software.

Results

The results showed that the main departments where SAEs occurred were oncology (35.25%), pulmonology (21.21%), and hematology (10.04%). SAEs were mainly concentrated in phase III clinical trials, accounting for 69.51% of the total SAE cases. The SAE predominantly affected the respiratory system, hematologic system, and gastrointestinal system, with grade 3 severity being most common (46.02%). The outcomes for research participants were generally favorable, 39.77% fully recovered and 25.00% improved.

Conclusion

Clinical trial institutions need to strengthen drug safety monitoring, promptly evaluate SAE, enhance supervision over SAEs, and safeguard the rights and safety of research participants.

clinical trial  /  serious adverse events  /  safety monitoring
Shu-hao KOU, Qin XIAO, Ya-ting LIU, Pei-jun XIAO, Yan-hong LUO, Jia ZHOU, Bin-yu ZENG, Qun QIN, Xin ZHANG. Analysis and intervention strategies for 528 cases of serious adverse events in tumor drug clinical trials based on ethical review[J]. Chinese Journal of Clinical Pharmacology, 2025 , 41 (20) : 2976 -2981 . DOI: 10.13699/j.cnki.1001-6821.2025.20.021
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Year 2025 volume 41 Issue 20
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Article Info
doi: 10.13699/j.cnki.1001-6821.2025.20.021
  • Receive Date：2025-05-14
  • Online Date：2026-08-05
  • Published：2025-10-28
Article Data
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History
  • Received：2025-05-14
Funding
Affiliations
    1.Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
    2.Department of Pharmacy, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
    3.National Clinical Research Center for Geriatric Diseases, Xiangya Hospital, Central South University, Changsha 410008, Hunan Province, China
    4.Hunan Provincial International Science and Technology Innovation Cooperation Base for Early Clinical Trials of Biological Products, Changsha 410008, Hunan Province, China
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