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

Characteristics analysis of clinical trial registration for CDK4/6 inhibitors based on the ClinicalTrials.gov and ChiCTR databases

摘要

目的: 了解CDK4/6抑制剂临床试验在ClinicalTrials.gov和ChiCTR数据库的注册情况,分析CDK4/6抑制剂临床试验的注册特点及发展趋势,为临床研究提供参考。方法: 检索ClinicalTrials.gov和ChiCTR数据库自建库以来至2025年4月17日关于CDK4/6抑制剂注册的所有临床试验,提取其注册时间、临床分期、样本量、适应证、注册状态、国家/地区、研究类型等信息,采用Excel表进行描述性统计分析。结果: 2个数据库中CDK4/6抑制剂临床研究的总注册数为765项,其中ClinicalTrials.gov数据库698项,ChiCTR数据库67项。涉及超过40个国家,排名前3位的分别为美国(397项)、中国(69项)、法国(22项)。2020年注册数量达到峰值,研究设计以干预性研究为主,适应证以乳腺癌研究为主,研究终点以疗效和安全性核心临床指标为主,但2个数据库在覆盖广度与探索深度上存在明显差异。结论: 本研究首次概述了CDK4/6抑制剂临床试验的注册情况,分析了ClinicalTrials.gov和ChiCTR数据库的临床试验注册特点。国际上研发起步早、覆盖广,国内以跟随创新和上市后研究为主,为CDK4/6抑制剂的临床研究方向及资源布局提供了参考。

Abstract

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.

关键词

CDK4/6抑制剂 / ClinicalTrials.gov / ChiCTR / 临床试验 / 注册特点

Key words

CDK4/6 inhibitors / ClinicalTrials.gov / ChiCTR / clinical trial / registration feature

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