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J Biopharm Stat. 2012;22(1):72-92. doi: 10.1080/10543406.2010.504906.

Genomic biomarkers for a binary clinical outcome in early drug development microarray experiments.

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Johnson & Johnson, PRD, Beerse, Belgium.


In this article, we discuss methods to select three different types of genes (treatment related, response related, or both) and investigate whether they can serve as biomarkers for a binary outcome variable. We consider an extension of the joint model introduced by Lin et al. (2010) and Tilahun et al. (2010) for a continuous response. As the model has certain drawbacks in a binary setting, we also present a way to use classical selection methods to identify subgroups of genes, which are treatment and/or response related. We evaluate their potential to serve as biomarkers by applying DLDA to predict the response level.

[Indexed for MEDLINE]

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