Fast-tracking drug development with biomarkers and companion diagnostics  

作　　者：Noreen McBrearty Devika Bahal Suso Platero 

机构地区：[1]Discovery Life Sciences,Newtown,PA 18940,USA

出　　处：《Journal of Cancer Metastasis and Treatment》2024年第1期321-331,共11页癌症转移与治疗(英文版)

摘　　要：To fully implement precision medicine,a deeper understanding of biomarkers,companion diagnostics,and their use in clinical trials is needed.Here,we describe key events in biomarker discovery and clinical trial design,and how those stages may be streamlined to fast-track approval of companion diagnostics(CDx).We discuss crucial qualities of a successful CDx that include understanding the prevalence of the marker in the intention to treat population,careful consideration of the scoring scheme that will be used in later clinical trial stages,and reliability of the performance of the CDx,in addition to other necessary features.

关 键 词：Biomarkers companion diagnostics ONCOLOGY personalized medicine drug development clinical trials regulatory approval 

分 类 号：R73[医药卫生—肿瘤]