Molecular Oncology
Volume 3, Issue 1 , Pages 24-32, February 2009

Biomarkers in oncology drug development

  • Darren R. Hodgson

      Affiliations

    • Oncology Therapy Area, AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK
    • Corresponding Author InformationCorresponding author. Tel.: +44 (0) 1625 516105; fax: +44 (0) 1625 516563.
    • ,
  • Robin D. Whittaker

      Affiliations

    • Oncology Therapy Area, AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK
    • ,
  • Athula Herath

      Affiliations

    • Statistical Science, AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK
    • ,
  • Dereck Amakye

      Affiliations

    • Oncology Therapy Area, AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK
    • ,
  • Glen Clack

      Affiliations

    • Oncology Therapy Area, AstraZeneca, Alderley Park, Macclesfield, Cheshire SK10 4TG, UK

Received 29 November 2008; accepted 2 December 2008. published online 29 December 2008.

Abstract 

Biomarker measurements have become an essential component of oncology drug development, particularly so in this era of targeted therapies. Such measurements ensure that clinical studies are testing our biological hypotheses and can help make the difficult decisions required to choose which drugs to stop developing or de-prioritise. For those drugs taken forward, biomarker measurements may also help choose the appropriate dose, schedule and patient population. In this review we discuss the intrinsic properties of biological sample based efficacy measurements and how these relate to their implementation in oncology drug development by way of points to consider and examples.

Keywords: Biomarker, Drug, Oncology, Surrogate, Tumour

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PII: S1574-7891(08)00152-X

doi:10.1016/j.molonc.2008.12.002

Molecular Oncology
Volume 3, Issue 1 , Pages 24-32, February 2009

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