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OA

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.