Integrating biomarkers in clinical trials

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

Research output: Contribution to journalReview articlepeer-review

90 Scopus citations


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 languageEnglish (US)
Pages (from-to)171-182
Number of pages12
JournalExpert Review of Molecular Diagnostics
Issue number2
StatePublished - Mar 2011


  • 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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