Journal
INTERNATIONAL JOURNAL OF BIOSTATISTICS
Volume 10, Issue 1, Pages 99-121Publisher
WALTER DE GRUYTER GMBH
DOI: 10.1515/ijb-2012-0052
Keywords
treatment selection marker; predictive marker; prescriptive marker; randomized trial; interaction
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Despite the heightened interest in developing biomarkers predicting treatment response that are used to optimize patient treatment decisions, there has been relatively little development of statistical methodology to evaluate these markers. There is currently no unified statistical framework for marker evaluation. This paper proposes a suite of descriptive and inferential methods designed to evaluate individual markers and to compare candidate markers. An R software package has been developed which implements these methods. Their utility is illustrated in the breast cancer treatment context, where candidate markers are evaluated for their ability to identify a subset of women who do not benefit from adjuvant chemotherapy and can therefore avoid its toxicity.
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