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Review
. 2013;2013:865980.
doi: 10.1155/2013/865980. Epub 2013 Apr 17.

Genomic Biomarkers for Personalized Medicine: Development and Validation in Clinical Studies

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Free PMC article
Review

Genomic Biomarkers for Personalized Medicine: Development and Validation in Clinical Studies

Shigeyuki Matsui. Comput Math Methods Med. .
Free PMC article

Abstract

The establishment of high-throughput technologies has brought substantial advances to our understanding of the biology of many diseases at the molecular level and increasing expectations on the development of innovative molecularly targeted treatments and molecular biomarkers or diagnostic tests in the context of clinical studies. In this review article, we position the two critical statistical analyses of high-dimensional genomic data, gene screening and prediction, in the framework of development and validation of genomic biomarkers or signatures, through taking into consideration the possible different strategies for developing genomic signatures. A wide variety of biomarker-based clinical trial designs to assess clinical utility of a biomarker or a new treatment with a companion biomarker are also discussed.

Figures

Figure 1
Figure 1
Biomarker strategy designs.
Figure 2
Figure 2
Enrichment design.
Figure 3
Figure 3
Randomize-all design with prestratification based on the biomarker.

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