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

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...

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Bibliographic Details
Main Author: Shigeyuki Matsui
Format: Article
Language:English
Published: Hindawi Limited 2013-01-01
Series:Computational and Mathematical Methods in Medicine
Online Access:http://dx.doi.org/10.1155/2013/865980
Description
Summary: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.
ISSN:1748-670X
1748-6718