title: Oncology biomarkers: discovery, validation, and clinical use.
abstract: OBJECTIVE
  To discuss the discovery, validation, and clinical use of multiple types of biomarkers.
  
  
  METHODS
  Medical literature and published guidelines.
  
  
  CONCLUSIONS
  Formal validation of biomarkers should include both retrospective analyses of well-characterized samples as well as a prospective clinical trial in which the biomarker is tested for its ability to predict the presence of disease or the efficacy of a cancer therapy.
  
  
  CONCLUSIONS
  Biomarker development is complicated, with very few biomarker discoveries leading to clinically useful tests. Nurses should understand how a biomarker was developed, including the sensitivity and specificity before applying new biomarkers in the clinical setting.
authors.affiliation: Divisionof Cancer Prevention, National Cancer Institute, Bethesda, MD 20892, USA. heckmanbm@mail.nih.gov
authors.forename: Brandy M
authors.initials: BM
authors.lastname: Heckman-Stoddard
mesh_terms: D001681:Biological Assay; D014408:Biomarkers, Tumor; D002986:Clinical Trials as Topic; D006801:Humans; D009369:Neoplasms / Q000235:genetics / Q000473:pathology*; D040901:Proteomics; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D014408:Biomarkers, Tumor