Genomic classifier for patient enrichment: Misclassification and type I error issues in pharmacogenomics noninferiority trial

Statistics in Biopharmaceutical Research

Volumn 3, Issue 2, 2011, Pages 310-319

  Wang, Sue Jane ^a   Hung, H M James ^a   O'Neill, Robert T ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

Biomarker qualification; Disease prevalence; False positive classification; Nondifferential misclassification; Noninferiority; Positive predictive value; Type I error probability

Indexed keywords

BIOLOGICAL MARKER; HEMOGLOBIN A1C; K RAS PROTEIN; PANITUMUMAB;

ARTICLE; BAYES THEOREM; CANCER PALLIATIVE THERAPY; COLORECTAL CANCER; DIAGNOSTIC ERROR; GENOMICS; HUMAN; METASTASIS; NON INSULIN DEPENDENT DIABETES MELLITUS; PATIENT SELECTION; PHARMACOGENOMICS; PHASE 3 CLINICAL TRIAL (TOPIC); PHENOTYPE; PREDICTIVE VALUE; PREVALENCE; PROBABILITY; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL (TOPIC); RISK; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY;

EID: 84867133480     PISSN: None     EISSN: 19466315     Source Type: Journal    
DOI: 10.1198/sbr.2010.10012     Document Type: Article

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