Methodological issues with pharmacogenomic biomarkers in relation to clinical development and patient selection

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Draft reflection paper

Reference numberEMA/CHMP/446337/2011
Published12/07/2011
KeywordsClinical trial designs, enriched design, genomic biomarkers (GBMS), hybrid design, predictive markers, pharmacogenomics, retrospective data analyses
DescriptionThis document highlights key principles that should be considered by stakeholders with focus on use of genomic biomarkers in relation to patient selection and associated issues with trial methodology.

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