Biomarker Discovery and Validation: Statistical Considerations

Fang Shu Ou, Stefan Michiels, Yu Shyr, Alex A. Adjei, Ann L. Oberg

Research output: Contribution to journalArticlepeer-review


Biomarkers have various applications including disease detection, diagnosis, prognosis, prediction of response to intervention, and disease monitoring. In this era of precision medicine, having validated biomarkers to inform clinical decision making is more important than ever. In this article, we discuss best the practices and potential issues in biomarker discovery and validation. We encourage team science partnerships to bring cutting-edge discovery from bench to bedside, leading to improved patient care and outcomes.

Original languageEnglish (US)
Pages (from-to)537-545
Number of pages9
JournalJournal of Thoracic Oncology
Issue number4
StatePublished - Apr 2021


  • Biomarker
  • Clinical trial
  • Confirmation analysis
  • Exploratory analysis

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine


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