Biomarkers and surrogate endpoints in clinical trials

Statistics in Medicine

Volumn 31, Issue 25, 2012, Pages 2973-2984

  Fleming, Thomas R ^a   Powers, John H ^b,c,d  

^a UNIVERSITY OF WASHINGTON   (United States)

^b SAIC FREDERICK INC   (United States)

^c NATIONAL INSTITUTES OF HEALTH   (United States)

^d GEORGE WASHINGTON UNIVERSITY SCHOOL OF MEDICINE AND HEALTH SCIENCES   (United States)

Author keywords

Accelerated approval; Clinical efficacy measure; Clinically meaningful endpoint; Correlate; Effect modifiers; Indirect measure; Replacement endpoint; Validation

Indexed keywords

BIOLOGICAL MARKER; CARCINOEMBRYONIC ANTIGEN; PROSTATE SPECIFIC ANTIGEN;

ARTICLE; CD4 LYMPHOCYTE COUNT; CLINICAL EFFECTIVENESS; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); DISEASE COURSE; DISEASE MARKER; HUMAN; OUTCOME ASSESSMENT; PATIENT CARE; PATIENT SAFETY; RELIABILITY; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; STUDY DESIGN; TREATMENT RESPONSE; VALIDATION PROCESS;

BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; ENDPOINT DETERMINATION; HUMANS; OUTCOME AND PROCESS ASSESSMENT (HEALTH CARE); REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN;

EID: 84867466093     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.5403     Document Type: Article

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