A review of phase II trial designs for initial marker validation

Contemporary Clinical Trials

Volumn 36, Issue 2, 2013, Pages 597-604

  Mandrekar, Sumithra J ^a   An, Ming Wen ^b   Sargent, Daniel J ^a  

^a MAYO CLINIC   (United States)

^b VASSAR COLLEGE   (United States)

Author keywords

Adaptive design; All comers design; Biomarker; Direct assignment; Enrichment design; Interim analysis

Indexed keywords

BIOLOGICAL MARKER; NEW DRUG;

ARTICLE; COLON CANCER; EXPERIMENTAL THERAPY; HISTOLOGY; HUMAN; INDUCTION CHEMOTHERAPY; LUNG NON SMALL CELL CANCER; LUNG SMALL CELL CANCER; MULTICENTER STUDY (TOPIC); PATIENT SAFETY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); RANDOMIZATION; RANDOMIZED CONTROLLED TRIAL (TOPIC); STUDY DESIGN; VALIDATION STUDY; VALIDITY;

ADAPTIVE DESIGN; ALL-COMERS DESIGN; BIOMARKER; DIRECT ASSIGNMENT; ENRICHMENT DESIGN; INTERIM ANALYSIS;

BIOLOGICAL MARKERS; CLINICAL PROTOCOLS; CLINICAL TRIALS, PHASE II AS TOPIC; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS;

EID: 84888132659     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2013.05.001     Document Type: Article

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