Article
Randomized Clinical Trials with Biomarkers for Stratified Oncology
Meeting Abstract
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Authors
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Stefan Michiels
- Department of Biostatistics and Epidemiology Gustave Roussy, Paris-Sud University, Paris, FR
| Published: | August 27, 2013 |
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Outline
Text
With the advent of the targeted therapy era, molecular biomarkers are becoming increasingly important for anticipating the prognosis of individual patients (‘prognostic’ biomarkers) or for predicting how individual patients will respond to specific treatments (‘predictive’ biomarkers, also called ‘effect modifiers’). In this talk, specific 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 strata defined by the presence or absence of the biomarker. An approach for identifying and validating a gene signature within a single trial will be outlined. Contemporary biomarker-based clinical trials in oncology are used as examples.
Literatur
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- 3.
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