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 Drug Companion Diagnostic Devices

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。

Objective:To systematically elucidate the principles of clinical trial design of the companion diagnostic 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 CDx developed simultaneously with anti-tumor drugs in China were introduced.Combined with the considerations during the relevant product technical review,the science and rationality of the clinical trials design of CDx were analyzed in depth.Results and Conclusion:The CDx plays a very important role in the clinical application of the anti-tumor drugs.The clinical trials of the CDx and the clinical trials of anti-tumor drugs are closely related.There are multiple types of designs for clinical trials of this kind of products.Clinical trial main investigators should choose the appropriate clinical trial designs based on the specifi c conditions of product development mode and product detection markers,which could evaluate the clinical signifi cance of the product more scientifi cally and reasonably,and promote the product to market as soon as possible.