Adaptive enrichment with subpopulation selection at interim: Methodologies, applications and design considerations

Contemporary Clinical Trials

Volumn 36, Issue 2, 2013, Pages 673-681

  Wang, Sue Jane ^a   Hung, H M James ^a  

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

Author keywords

Biomarker; Dual composite null hypothesis; Flexible dual independent null hypothesis; Pharmacogenomics; Rigorous dual independent null hypothesis

Indexed keywords

BIOLOGICAL MARKER;

ADAPTATION; ADAPTIVE ENRICHMENT; ARTICLE; CLINICAL TRIAL (TOPIC); DRUG APPROVAL; HUMAN; INFORMATION PROCESSING; LITERATURE; METHODOLOGY; MIGRAINE; NULL HYPOTHESIS; PERSONALIZED MEDICINE; POPULATION RESEARCH; SAMPLE SIZE; STUDY DESIGN; TREATMENT OUTCOME;

BIOMARKER; DUAL-COMPOSITE NULL HYPOTHESIS; FLEXIBLE DUAL-INDEPENDENT NULL HYPOTHESIS; PHARMACOGENOMICS; RIGOROUS DUAL-INDEPENDENT NULL HYPOTHESIS;

ADOLESCENT; CHILD; CLINICAL PROTOCOLS; DATA INTERPRETATION, STATISTICAL; DRUG APPROVAL; DRUG THERAPY; HUMANS; INDIVIDUALIZED MEDICINE; MIGRAINE DISORDERS; PHARMACOGENETICS; SAMPLE SIZE; TREATMENT OUTCOME;

EID: 84888132560     PISSN: 15517144     EISSN: 15592030     Source Type: Journal    
DOI: 10.1016/j.cct.2013.09.008     Document Type: Article

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