Statistical and Practical Considerations for Clinical Evaluation of Predictive Biomarkers
作者： M.-Y. C. Polley , B. Freidlin , E. L. Korn , B. A. Conley , J. S. Abrams
DOI: 10.1093/JNCI/DJT282
关键词: Randomized controlled trial 、 Predictive biomarker 、 Immunology 、 Predictive value of tests 、 Intensive care medicine 、 Biology 、 Clinical evaluation 、 Precision medicine 、 Biomarker (medicine) 、 Sample size determination 、 Personalized medicine
摘要: Predictive biomarkers to guide therapy for cancer patients are a cornerstone of precision medicine. Discussed herein considerations regarding the design and interpretation such predictive biomarker studies. These important both planning interpreting prospective studies using specimens collected from completed randomized clinical trials. Specific issues addressed differentiation between qualitative quantitative effects, challenges due sample size requirements assessment, consideration additional factors relevant utility as toxicity cost new therapies well costs potential morbidities associated with routine use biomarker-based tests.
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