Journal
STATISTICS IN MEDICINE
Volume 34, Issue 2, Pages 317-342Publisher
WILEY-BLACKWELL
DOI: 10.1002/sim.6343
Keywords
biomarker; patient rule induction method (PRIM); patient stratification; predictive signature; subgroup analysis
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Funding
- National Institutes of Health [1R21 GM110450-01]
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Patients often respond differently to a treatment because of individual heterogeneity. Failures of clinical trials can be substantially reduced if, prior to an investigational treatment, patients are stratified into responders and nonresponders based on biological or demographic characteristics. These characteristics are captured by a predictive signature. In this paper, we propose a procedure to search for predictive signatures based on the approach of patient rule induction method. Specifically, we discuss selection of a proper objective function for the search, present its algorithm, and describe a resampling scheme that can enhance search performance. Through simulations, we characterize conditions under which the procedure works well. To demonstrate practical uses of the procedure, we apply it to two real-world data sets. We also compare the results with those obtained from a recent regression-based approach, Adaptive Index Models, and discuss their respective advantages. In this study, we focus on oncology applications with survival responses. (c) 2014 The Authors. Statistics in Medicine published by John Wiley & Sons Ltd.
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