The impact of companion diagnostic device measurement performance on clinical validation of personalized medicine

Statistics in Medicine

Volumn 34, Issue 14, 2015, Pages 2222-2234

  Li, Meijuan ^a   Yu, Tinghui ^a   Hu, Yun Fu ^a  

^a CENTER FOR DEVICES AND RADIOLOGICAL HEALTH   (United States)

Author keywords

Analytical accuracy; Biomarker; Clinical validation trial; Companion diagnostic device; Imprecision; Positive and negative percentage agreements; Positive and negative predictive values

Indexed keywords

APOLIPOPROTEIN E; BIOLOGICAL MARKER; APOLIPOPROTEIN E4; GENETIC MARKER;

ALZHEIMER DISEASE; ARTICLE; COMPANION DIAGNOSTIC DEVICE; CONTROLLED STUDY; DEVICE MEASUREMENT PERFORMANCE; DIAGNOSTIC EQUIPMENT; HUMAN; MEASUREMENT ACCURACY; MEASUREMENT PRECISION; PERSONALIZED MEDICINE; PREDICTIVE VALUE; QUALITATIVE ANALYSIS; SAMPLE SIZE; STATISTICAL ANALYSIS; THERAPY EFFECT; TREATMENT OUTCOME; VALIDATION STUDY; VARIANCE; CLINICAL TRIAL (TOPIC); EARLY DIAGNOSIS; GENETIC MARKER; GENETIC PREDISPOSITION; GENETICS; MOLECULAR BIOLOGY; OUTCOME ASSESSMENT; PROCEDURES; REPRODUCIBILITY; RISK FACTOR; SECONDARY PREVENTION; STATISTICAL MODEL; STATISTICS AND NUMERICAL DATA;

ALZHEIMER DISEASE; APOLIPOPROTEIN E4; CLINICAL TRIALS AS TOPIC; EARLY DIAGNOSIS; GENETIC MARKERS; GENETIC PREDISPOSITION TO DISEASE; HUMANS; LIKELIHOOD FUNCTIONS; MOLECULAR BIOLOGY; OUTCOME ASSESSMENT (HEALTH CARE); PRECISION MEDICINE; REPRODUCIBILITY OF RESULTS; RISK FACTORS; SECONDARY PREVENTION;

EID: 84930180871     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.6476     Document Type: Article

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