Integrating biomarkers in clinical trials

Marc Buyse; Stefan Michiels; Daniel J. Sargent; Axel Grothey; Alastair Matheson; Aimery De Gramont

doi:10.1586/erm.10.120

Integrating biomarkers in clinical trials

Marc Buyse, Stefan Michiels, Daniel J. Sargent, Axel Grothey, Alastair Matheson, Aimery De Gramont

Research output: Contribution to journal › Review article › peer-review

90 Scopus citations

Abstract

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.

Original language	English (US)
Pages (from-to)	171-182
Number of pages	12
Journal	Expert Review of Molecular Diagnostics
Volume	11
Issue number	2
DOIs	https://doi.org/10.1586/erm.10.120
State	Published - Mar 2011

Keywords

biomarker
predictive marker
prognostic marker
trial design
validation

ASJC Scopus subject areas

Pathology and Forensic Medicine
Molecular Medicine
Molecular Biology
Genetics

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10.1586/erm.10.120

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AU - Matheson, Alastair

AU - De Gramont, Aimery

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AB - 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.

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Integrating biomarkers in clinical trials

Abstract

Keywords

ASJC Scopus subject areas

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