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• [1] Institute NC. "biomarker". NCI Dictionary of Cancer Terms.
• [2] Colburn W, DeGruttola V, DeMets D, Downing G, Hoth D, Oates J, et al. Biomarkers and surrogate endpoints: preferred definitions and conceptual framework. Biomarkers Definitions Working Group. Clin Pharmacol Ther 2001;69:89-95.
• [3] Jenkins M, Flynn A, Smart T, Harbron C, Sabin T, Ratnayake J, et al. A statistician's perspective on biomarkers in drug development. Pharm Stat 2011;10:494-507.
• [4] Schilsky RL, Halabi S. Oncology Clinical Trials: Successful Design, Conduct and Analysis: Demos Medical Publishing; 2009.
• [5] Mayeux R. Biomarkers: potential uses and limitations. NeuroRx 2004;1:182-8.
• [6] Gosho M, Nagashima K, Sato Y. Study designs and statistical analyses for biomarker research. Sensors (Basel) 2012;12:8966-86.
• [7] Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges. J Clin Oncol 2009;27:4027-34.
• [8] Mandrekar SJ, Sargent DJ. Clinical trial designs for predictive biomarker validation: one size does not fit all. J Biopharm Stat 2009;19:530-42.
• [9] Simon R. Biomarker based clinical trial design. Chin Clin Oncol 2014;3:39.
• [10] Simon R, Maitournam A. Evaluating the efficiency of targeted designs for randomized clinical trials. Clin Cancer Res 2004;10:6759-63.
• [11] Freidlin B, Simon R. Adaptive signature design: an adaptive clinical trial design for generating and prospectively testing a gene expression signature for sensitive patients. Clin Cancer Res 2005;11:7872-8.
• [12] Jiang W, Freidlin B, Simon R. Biomarker-adaptive threshold design: a procedure for evaluating treatment with possible biomarker-defined subset effect. J Natl Cancer Inst 2007;99:1036-43.
• [13] Wang SJ, O'Neill RT, Hung H. Approaches to evaluation of treatment effect in randomized clinical trials with genomic subset. Pharm Stat 2007;6:227-44.
• [14] Zhou X, Liu S, Kim ES, Herbst RS, Lee JJ. Bayesian adaptive design for targeted therapy development in lung cancer--a step toward personalized medicine. Clin Trials 2008;5:181-93.
• [15] Pencina MJ, D'Agostino RB, Steyerberg EW. Extensions of net reclassification improvement calculations to measure usefulness of new biomarkers. Stat Med 2011;30:11-21.
• [16] Pencina MJ, D'Agostino RB, Vasan RS. Evaluating the added predictive ability of a new marker: from area under the ROC curve to reclassification and beyond. Stat Med 2008;27:157-72.