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"Studies need to be conducted to determine the optimal design for using genome-wide profiling to identify putative biomarkers of drug response. To date, most biomarkers of drug response identified through genome-wide profiling have occurred through retrospective analysis of available tissue. To really progress this field, realistic planning for biomarker discovery and validation in clinical trials needs to be conducted. We, as clinical scientists, need to progress from only using convenient clinical cohorts to identify biomarkers to actually planning and following through with prospective clinical trials whose aims are to discover and/or validate putative biomarkers of drug response. To initiate a study without a realistic plan for discovery and validation reflects a lack of serious desire to find robust clinical predictors..... Until this becomes more commonplace, the genomic revolution will be focused on manuscript generation and investigator career development, leaving the benefit to patients nothing more than an unrealized dream."
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