par Buyse, Marc;Michiels, Stefan 
;Sargent, Daniel D.J.;Grothey, Axel;Matheson, Alastair;de Gramont, Aimery
Référence Expert review of molecular diagnostics, 11, 2, page (171-182)
Publication Publié, 2011-03
;Sargent, Daniel D.J.;Grothey, Axel;Matheson, Alastair;de Gramont, AimeryRéférence Expert review of molecular diagnostics, 11, 2, page (171-182)
Publication Publié, 2011-03
Article révisé par les pairs
| Résumé : | 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 III 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. © 2011 Expert Reviews Ltd. |
