Predictive biomarkers for personalised anti-cancer drug use: Discovery to clinical implementation

Nayef A. Alymani, Murray D. Smith, David J. Williams, Russell D. Petty*

*Corresponding author for this work

Research output: Contribution to journalReview Articlepeer-review

43 Citations (Scopus)


A priority translational research objective in cancer medicine is the discovery of novel therapeutic targets for solid tumours. Ideally, co-discovery of predictive biomarkers occurs in parallel to facilitate clinical development of agents and ultimately personalise clinical use. However, the identification of clinically useful predictive biomarkers for solid tumours has proven challenging with many initially promising biomarkers failing to translate into clinically useful applications. In particular, the 'failure' of a predictive biomarker has often only become apparent at a relatively late stage in investigation. Recently, the field has recognised the need to develop a robust clinical biomarker development methodology to facilitate the process. This review discusses the recent progress in this area focusing on the key stages in the biomarker development process: discovery, validation, qualification and implementation. Concentrating on predictive biomarkers for selecting systemic therapies for individual patients in the clinic, the advances and progress in each of these stages in biomarker development are outlined and the key remaining challenges are discussed. Specific examples are discussed to illustrate the challenges identified and how they have been addressed. Overall, we find that significant progress has been made towards a formalised biomarker developmental process. This holds considerable promise for facilitating the translation of predictive biomarkers from discovery to clinical implementation. Further enhancements could eventually be found through alignment with regulatory processes.

Original languageEnglish
Pages (from-to)869-879
Number of pages11
JournalEuropean Journal of Cancer
Issue number5
Early online date05 Feb 2010
Publication statusPublished - 01 Mar 2010
Externally publishedYes


  • Anti-cancer agents
  • Biomarkers
  • Personalised therapy
  • Targeted Agents
  • Drug Discovery/methods
  • Reproducibility of Results
  • Humans
  • Antineoplastic Agents/therapeutic use
  • Neoplasms/drug therapy
  • Biomarkers, Tumor
  • Translational Research, Biomedical/methods
  • Drug Screening Assays, Antitumor/methods
  • Clinical Trials as Topic/methods
  • Precision Medicine


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