Clinical trial designs for predictive biomarker validation: One size does not fit all

Journal of Biopharmaceutical Statistics

Volumn 19, Issue 3, 2009, Pages 530-542

  Mandrekar, Sumithra J ^a   Sargent, Daniel J ^a  

^a MAYO CLINIC   (United States)

Author keywords

Biomarker; Enrichments designs; Predictive marker designs; Unselected designs

Indexed keywords

BIOLOGICAL MARKER; CYCLOPHOSPHAMIDE; DOXORUBICIN; EPIDERMAL GROWTH FACTOR RECEPTOR 2; EPIDERMAL GROWTH FACTOR RECEPTOR KINASE INHIBITOR; ERLOTINIB; GEFITINIB; PACLITAXEL; PANITUMUMAB; TRASTUZUMAB; EGFR PROTEIN, HUMAN; EPIDERMAL GROWTH FACTOR RECEPTOR; ERBB2 PROTEIN, HUMAN; KRAS PROTEIN, HUMAN; MONOCLONAL ANTIBODY; ONCOPROTEIN; RAS PROTEIN; TUMOR MARKER;

ASSAY; BREAST CANCER; CANCER PATIENT; CASE STUDY; CLINICAL TRIAL; COMPARATIVE STUDY; DIFFERENTIAL DIAGNOSIS; DISEASE MARKER; DRUG RESPONSE; GENETICS; GENOTYPE; HAZARD RATIO; KIRSTEN SARCOMA ONCOVIRUS; LUNG CANCER; MEDICINE; METHODOLOGY; PATIENT CARE; PREDICTION; PREVALENCE; PRIORITY JOURNAL; PRODUCTIVITY; REPRODUCIBILITY; REVIEW; RISK ASSESSMENT; SAMPLE SIZE; SENSITIVITY AND SPECIFICITY; STRATIFICATION; STRENGTH; TREATMENT RESPONSE; VALIDATION PROCESS; ARTICLE; BIOASSAY; BIOSYNTHESIS; BREAST TUMOR; COLORECTAL TUMOR; DISEASE FREE SURVIVAL; DRUG EFFECT; HUMAN; LUNG NON SMALL CELL CANCER; LUNG TUMOR; METABOLISM; PREDICTION AND FORECASTING; PROPORTIONAL HAZARDS MODEL; STATISTICS;

ANTIBODIES, MONOCLONAL; BREAST NEOPLASMS; CARCINOMA, NON-SMALL-CELL LUNG; CLINICAL TRIALS AS TOPIC; COLORECTAL NEOPLASMS; DISEASE-FREE SURVIVAL; ENDPOINT DETERMINATION; HUMANS; LUNG NEOPLASMS; PREDICTIVE VALUE OF TESTS; PROPORTIONAL HAZARDS MODELS; PROTO-ONCOGENE PROTEINS; RAS PROTEINS; RECEPTOR, EPIDERMAL GROWTH FACTOR; RECEPTOR, ERBB-2; RESEARCH DESIGN; TUMOR MARKERS, BIOLOGICAL;

EID: 67651030311     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543400902802458     Document Type: Review

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