Statistical and practical considerations for clinical evaluation of predictive biomarkers

Mei Yin C. Polley, Boris Freidlin, Edward L. Korn, Barbara A. Conley, Jeffrey S. Abrams, Lisa M. McShane

Research output: Contribution to journalReview articlepeer-review

89 Scopus citations


Predictive biomarkers to guide therapy for cancer patients are a cornerstone of precision medicine. Discussed herein are considerations regarding the design and interpretation of such predictive biomarker studies. These considerations are important for both planning and interpreting prospective studies and for using specimens collected from completed randomized clinical trials. Specific issues addressed are differentiation between qualitative and quantitative predictive effects, challenges due to sample size requirements for predictive biomarker assessment, and consideration of additional factors relevant to clinical utility assessment, such as toxicity and cost of new therapies as well as costs and potential morbidities associated with routine use of biomarker-based tests.

Original languageEnglish (US)
Pages (from-to)1677-1683
Number of pages7
JournalJournal of the National Cancer Institute
Issue number22
StatePublished - Nov 20 2013

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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