Adaptive design clinical trials and trial logistics models in CNS drug development

European Neuropsychopharmacology

Volumn 21, Issue 2, 2011, Pages 159-166

  Wang, Sue Jane ^a   Hung, H M James ^a   O'Neill, Robert ^a  

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

Author keywords

Learn and Confirm; Learn versus Confirm; Sample size re estimation; Trial logistics model; Two stage adaptive selection

Indexed keywords

BIOLOGICAL MARKER; CENTRAL NERVOUS SYSTEM AGENTS; PLACEBO;

ADAPTIVE DESIGN; CLINICAL TRIAL (TOPIC); DRUG DOSE REGIMEN; DRUG EFFICACY; DRUG RESEARCH; EXPLORATORY RESEARCH; FOOD AND DRUG ADMINISTRATION; NEUROLOGIC DISEASE; OUTCOME ASSESSMENT; PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; SAMPLE SIZE; SIMULATION; STATISTICAL MODEL; STUDY DESIGN;

CENTRAL NERVOUS SYSTEM AGENTS; CENTRAL NERVOUS SYSTEM DISEASES; CLINICAL TRIALS AS TOPIC; HUMANS; LOGISTIC MODELS; RESEARCH DESIGN; SAMPLE SIZE; TREATMENT OUTCOME;

EID: 78751608557     PISSN: 0924977X     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.euroneuro.2010.09.003     Document Type: Review

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