Translational research in phase I trials

Angelica Fasolo, Cristiana Sessa

Research output: Contribution to journalArticlepeer-review


"Translational research" (TR) has the main aim of transferring the results of preclinical research into clinical practice and includes the study of the biology of the disease to provide solid rationales for the development or improvement of new drugs, the evaluation of the biological effects of the drugs in animals to defi ne how to best use those drugs in humans and the study of the biological effects of those drugs in humans. To facilitate the development of new cancer targeted therapies, TR focuses its efforts on the discovery and validation of biomarkers, defi ned as "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes or pharmacologic responses to a therapeutic intervention". Biomarkers could allow a rational development of targeted agents, based on the mechanistic assessment of their effects. This knowledge can then be used during the subsequent steps of drug discovery, screening, preclinical and clinical testing. This review will focus on the contributions provided by biomarkers to facilitate the development of new targeted therapies.

Original languageEnglish
Pages (from-to)580-588
Number of pages9
JournalClinical and Translational Oncology
Issue number9
Publication statusPublished - Sep 2009


  • Biomarkers
  • Drug development
  • Phase I studies
  • Target therapies
  • Translational research

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Medicine(all)


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