Subgroup identification for treatment selection in biomarker adaptive design
作者: Tzu-Pin LuJames J. Chen
作者单位: 1Food and Drug Administration
2National Taiwan University
3China Medical University
刊名: BMC Medical Research Methodology, 2015, Vol.15 (1)
来源数据库: Springer Nature Journal
DOI: 10.1186/s12874-015-0098-7
关键词: Adaptive signature designClassificationPersonalized medicinePredictive classifierSubgroup analysisSubgroup selection
原始语种摘要: Abstract(#br) Background(#br)Advances in molecular technology have shifted new drug development toward targeted therapy for treatments expected to benefit subpopulations of patients. Adaptive signature design (ASD) has been proposed to identify the most suitable target patient subgroup to enhance efficacy of treatment effect. There are two essential aspects in the development of biomarker adaptive designs: 1) an accurate classifier to identify the most appropriate treatment for patients, and 2) statistical tests to detect treatment effect in the relevant population and subpopulations. We propose utilization of classification methods to identity patient subgroups and present a statistical testing strategy to detect treatment effects.(#br) Methods(#br)The diagonal linear discriminant...
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影响因子:2.211 (2012)

  • identification 辨认
  • biomarker 生物标志化合物
  • adaptive 适应的
  • treatment 处理
  • selection 选择
  • design 设计