医药导报2026，Vol.45Issue(6)：1044-1050,7.DOI:10.3870/j.issn.1004-0781.2026.06.015
精准医疗下药物临床试验中伴随诊断试剂研究的管理与实践
Management and Practice of Companion Diagnostic Reagents Research in Drug Clinical Trials Within the Framework of Precision Medicine
摘要
Abstract
Objective From the perspective of clinical trial institutions,to analyzes the multiple compliance challenges associated with the research and application of companion diagnostic reagents in drug clinical trials within the framework of preci-sion medicine,and proposes targeted management strategies.Methods Through literature review and interpretation of relevant regulations and policies,this study compared the differences in the supervision model of companion diagnostic reagent clinical tri-als between China and other countries.Furthermore,combined with practical experiences,the pivotal compliance challenges ex-isting in companion diagnostic reagent clinical trials in China were summarized.Results Within the distinctive"dual-track"supervision model of clinical trials in China,the traditional management approach"separate management of drugs and devices"has had obvious conflicts with the"cross domain"attribute of companion diagnostic reagents.Based on the current management system,compliance risks of companion diagnostic reagents clinical trials may arise in three key aspects:approval path,use of tri-al participants' biological samples and personal information disclosure,and human genetic resources management.Conclusions Clinical trial institutions should establish an"identification"mechanism for the full life cycle of companion diagnostic reagents clinical trials,construct a"separate project approval"mode,and carry out"intensive"management.By implementing the core strategy of"one set of materials,separate submission and integrated management",clinical trial institutions can strictly control risk points,so as to achieve the dual objectives of normative supervision and efficient operation.关键词
精准医疗/药物临床试验/伴随诊断试剂/集约化管理Key words
Precision medicine/Drug clinical trial/Companion diagnostic reagent/Intensive management分类
医药卫生引用本文复制引用
冯钰,储天晴,颜波,陈仲林..精准医疗下药物临床试验中伴随诊断试剂研究的管理与实践[J].医药导报,2026,45(6):1044-1050,7.基金项目
2023年上海申康医院发展中心《促进市级医院临床技能与临床创新三年行动计划》研究型医师创新转化能力培训项目(SHDC2023CRS046). （SHDC2023CRS046）
