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Characteristics analysis of clinical trial registration for CDK4/6 inhibitors based on the ClinicalTrials.gov and ChiCTR databases
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Juan ZHANG1, Xue-yan LIU1, *, Gui-sen YIN2, Si-tong YANG3
Chinese Journal of New Drugs | 2026, 35(13) : 1409 - 1416
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Chinese Journal of New Drugs | 2026, 35(13): 1409-1416
Characteristics analysis of clinical trial registration for CDK4/6 inhibitors based on the ClinicalTrials.gov and ChiCTR databases
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Juan ZHANG1, Xue-yan LIU1, *, Gui-sen YIN2, Si-tong YANG3
Affiliations
  • 1Department of Pharmacy, Yantai Yuhuangding Hospital, Yantai 264000, China
  • 2Department of Clinical Pharmacy, Yantai Hospital of Traditional Chinese Medicine, Yantai 264000, China
  • 3Taibai Lake Campus of Jining Medical University, Jining 272000, China
Published: 2026-07-15 doi: 10.20251/j.cnki.1003-3734.2026.13.010
Outline
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Objective:

To investigate the registration status of clinical trials on CDK4/6 inhibitors in ClinicalTrials.gov and the Chinese Clinical Trial Registry (ChiCTR), analyze their registration characteristics and development trends, and provide a reference for clinical research.

Methods:

All clinical trials on CDK4/6 inhibitors registered in ClinicalTrials.gov and ChiCTR from the establishment of the database to April 17, 2025 were retrieved. Information including registration date, clinical phase, sample size, indication, registration status, country/region, and study type was extracted. Descriptive statistical analysis was performed using Excel.

Results:

A total of 765 clinical trials on CDK4/6 inhibitors were registered in the two databases, including 698 in ClinicalTrials.gov and 67 in ChiCTR. These trials involved more than 40 countries, with the top three being the United States (397 trials), China (69 trials), and France (22 trials). The number of registrations peaked in 2020. Most trials were interventional studies, with breast cancer as the primary indication. The main endpoints were core clinical indicators of efficacy and safety. However, there were significant differences between the two databases in terms of coverage breadth and research depth.

Conclusion:

This study is the first to summarize the registration status of CDK4/6 inhibitor clinical trials and analyze the registration characteristics in ClinicalTrials.gov and ChiCTR. Internationally, research and development started early with wide coverage, while domestic research mainly focuses on follow-up innovation and post-marketing studies, providing a reference for the direction of clinical research and resource allocation related to CDK4/6 inhibitors.

CDK4/6 inhibitors  /  ClinicalTrials.gov  /  ChiCTR  /  clinical trial  /  registration feature
张娟, 刘雪艳, 尹桂森, 杨斯童. 基于ClinicalTrials.gov和ChiCTR数据库对CDK4/6抑制剂临床试验注册特点分析. 中国新药杂志, 2026 , 35 (13) : 1409 -1416 . DOI: 10.20251/j.cnki.1003-3734.2026.13.010
Juan ZHANG, Xue-yan LIU, Gui-sen YIN, Si-tong YANG. Characteristics analysis of clinical trial registration for CDK4/6 inhibitors based on the ClinicalTrials.gov and ChiCTR databases[J]. Chinese Journal of New Drugs, 2026 , 35 (13) : 1409 -1416 . DOI: 10.20251/j.cnki.1003-3734.2026.13.010
Year 2026 volume 35 Issue 13
51
10
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Article Info
doi: 10.20251/j.cnki.1003-3734.2026.13.010
  • Online Date:2026-10-26
  • Published:2026-07-15
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History
  • Accepted:2025-09-18
Affiliations
    1Department of Pharmacy, Yantai Yuhuangding Hospital, Yantai 264000, China
    2Department of Clinical Pharmacy, Yantai Hospital of Traditional Chinese Medicine, Yantai 264000, China
    3Taibai Lake Campus of Jining Medical University, Jining 272000, China
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表12种不同金属材料的力学参数
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Family
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Number of
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Number of
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Number of
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鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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