文章摘要
徐超,方丽,李冉,吕允凤.抗肿瘤药物伴随诊断试剂临床试验设计探究及案例分析[J].中国药事,2024,38(1):66-70
抗肿瘤药物伴随诊断试剂临床试验设计探究及案例分析
Analysis and Case Study of the Clinical Trial Design for the Antitumor DrugCompanion Diagnostic Devices
投稿时间:2023-05-05  
DOI:10.16153/j.1002-7777.2024.01.009
中文关键词: 伴随诊断试剂  开发模式  临床试验设计  桥接试验  案例分析
英文关键词: companion diagnostic devices (CDx)  development models  clinical trial design  bridge study  casestudy analysis
基金项目:
作者单位
徐超 国家药品监督管理局医疗器械技术审评中心北京 100081 
方丽 国家药品监督管理局医疗器械技术审评中心北京 100081 
李冉 国家药品监督管理局医疗器械技术审评中心北京 100081 
吕允凤 国家药品监督管理局医疗器械技术审评中心北京 100081 
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中文摘要:
      目的:系统阐述我国伴随诊断试剂临床试验设计原则,为相关伴随诊断试剂产品临床试验提供参考。方法:基于不同伴随诊断试剂的开发模式,介绍我国与抗肿瘤药物同步开发的原研伴随诊断试剂及非原研伴随诊断试剂的临床试验设计,结合相关产品技术审评过程中的考虑,深入分析伴随诊断试剂临床试验设计的科学性与合理性。结果与结论:伴随诊断试剂在抗肿瘤药物临床应用中具有非常重要的作用,伴随诊断试剂的临床试验与抗肿瘤药物的临床试验息息相关,该类产品临床试验有多种设计类型,临床试验主要研究者应结合产品开发模式、产品检测的标志物等具体情况,选择合适的临床试验设计,能够更加科学合理地评价产品临床意义,促进产品尽快上市。
英文摘要:
      Objective: To systematically elucidate the principles of clinical trial design of the companiondiagnostic devices (CDx) in our country, and to provide references for the clinical trials of related CDx. Methods:Based on the diff erent development models of CDx, the clinical trial designs of the original and non-original CDxdeveloped simultaneously with anti-tumor drugs in China were introduced. Combined with the considerationsduring the relevant product technical review, the science and rationality of the clinical trials design of CDx wereanalyzed in depth. Results and Conclusion: The CDx plays a very important role in the clinical application of theanti-tumor drugs. The clinical trials of the CDx and the clinical trials of anti-tumor drugs are closely related. Thereare multiple types of designs for clinical trials of this kind of products. Clinical trial main investigators shouldchoose the appropriate clinical trial designs based on the specifi c conditions of product development mode andproduct detection markers, which could evaluate the clinical signifi cance of the product more scientifi cally andreasonably, and promote the product to market as soon as possible.
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