Integrating biomarkers in clinical trials

被引：0
作者：
Buyse, Marc [1 ]
Michiels, Stefan [2 ]
Sargent, Daniel J. [3 ]
Grothey, Axel [4 ]
Matheson, Alastair [5 ]
de Gramont, Aimery [6 ]
机构：
[1] Int Inst Drug Dev, B-1340 Louvain, Belgium
[2] Inst Jules Bordet, B-1000 Brussels, Belgium
[3] Mayo Clin, Ctr Canc, Div Biomed Stat & Informat, Rochester, MN 55905 USA
[4] Mayo Clin, Coll Med, Dept Med Oncol, Rochester, MN 55905 USA
[5] Fdn ARCAD, F-75004 Paris, France
[6] Hop St Antoine, F-75012 Paris 12, France
来源：
EXPERT REVIEW OF MOLECULAR DIAGNOSTICS | 2011年 / 11卷 / 02期
关键词：
biomarker; predictive marker; prognostic marker; trial design; validation; CELL LUNG-CANCER; GENE-EXPRESSION SIGNATURE; BAYESIAN ADAPTIVE DESIGN; METASTATIC BREAST-CANCER; SURROGATE END-POINTS; ADJUVANT CHEMOTHERAPY; PROGNOSTIC SIGNATURE; MOLECULAR MARKERS; PREDICTIVE MARKER; TARGETED THERAPY;
D O I：
10.1586/ERM.10.120
中图分类号：
R36 [病理学];
学科分类号：
100104 ;
摘要：
Biomarkers have a growing role in clinical trials. With the advent of the targeted therapy era, molecular biomarkers in particular are becoming increasingly important within both clinical research and clinical practice. This article focuses on biomarkers that anticipate the prognosis of individual patients ('prognostic' biomarkers) and on biomarkers that predict how individual patients will respond to specific treatments ('predictive' biomarkers, also called 'effect modifiers'). Specific Phase II and Ill clinical trial designs are discussed in detail for their ability to validate the biomarker and/or to establish the effect of an experimental therapy in patient populations defined by the presence or absence of the biomarker. Contemporary biomarker-based clinical trials in oncology are used as examples.
引用
收藏
页码：171 / 182
页数：12
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