Statistical and practical considerations for clinical evaluation of predictive biomarkers

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

Research output: Contribution to journalReview article

64 Citations (Scopus)

Abstract

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
Volume105
Issue number22
DOIs
StatePublished - Nov 20 2013
Externally publishedYes

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Biomarkers
Costs and Cost Analysis
Precision Medicine
Sample Size
Randomized Controlled Trials
Prospective Studies
Morbidity
Therapeutics
Neoplasms

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Statistical and practical considerations for clinical evaluation of predictive biomarkers. / Polley, Mei-Yin; Freidlin, Boris; Korn, Edward L.; Conley, Barbara A.; Abrams, Jeffrey S.; McShane, Lisa M.

In: Journal of the National Cancer Institute, Vol. 105, No. 22, 20.11.2013, p. 1677-1683.

Research output: Contribution to journalReview article

Polley, Mei-Yin ; Freidlin, Boris ; Korn, Edward L. ; Conley, Barbara A. ; Abrams, Jeffrey S. ; McShane, Lisa M. / Statistical and practical considerations for clinical evaluation of predictive biomarkers. In: Journal of the National Cancer Institute. 2013 ; Vol. 105, No. 22. pp. 1677-1683.
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