From darkness to light with biomarkers in early clinical trials of cancer drugs

Clin Pharmacol Ther. 2009 Feb;85(2):131-3. doi: 10.1038/clpt.2008.223.


Compared with conventional chemotherapy, rationally designed molecularly targeted agents may be more likely to have antitumor activity in selected tumor subgroups driven by the oncogenic signals targeted by these compounds and a different side-effect profile. The use of biomarkers in the early clinical trials of these new anticancer agents has the potential to increase study participants' benefit from early clinical trials, accelerate the drug development process, maximize the ability to generate important biological information about human cancer, and decrease the risk of late and costly drug attrition.

Publication types

  • Research Support, Non-U.S. Gov't
  • Review

MeSH terms

  • Animals
  • Antineoplastic Agents / therapeutic use*
  • Biomarkers, Tumor* / metabolism
  • Clinical Trials as Topic / methods
  • Clinical Trials as Topic / trends*
  • Darkness
  • Humans
  • Light
  • Neoplasms / drug therapy*
  • Neoplasms / genetics
  • Neoplasms / metabolism*
  • Time Factors


  • Antineoplastic Agents
  • Biomarkers, Tumor