Understanding the FDA guidance on adaptive designs: Historical, legal, and statistical perspectives

Journal of Biopharmaceutical Statistics

Volumn 20, Issue 6, 2010, Pages 1178-1219

  Liu, Qing ^a   Chi, George Y H ^a  

^a JOHNSON AND JOHNSON PHARMACEUTICAL RESEARCH AND DEVELOPMENT   (United States)

Author keywords

Adaptive design; Adaptive error spending; Blinding; Conditional power; Design optimization; Dose response; Efficiency; FDA guidance; Group sequential design; Null neutral principle; Sample size adjustment; Sources of bias; Stochastic curtailment; Type I error rate

Indexed keywords

ADAPTIVE DESIGN; CLINICAL RESEARCH; DOSE RESPONSE; FOOD AND DRUG ADMINISTRATION; HISTORY OF MEDICINE; HUMAN; LEGAL ASPECT; MEDICAL LITERATURE; METHODOLOGY; MONITORING; PRIORITY JOURNAL; REVIEW; SAMPLE SIZE; STATISTICAL ANALYSIS; STOCHASTIC MODEL; SYSTEMATIC ERROR; THEORY;

BIAS (EPIDEMIOLOGY); CLINICAL TRIALS AS TOPIC; DATA INTERPRETATION, STATISTICAL; DOSE-RESPONSE RELATIONSHIP, DRUG; DRUG APPROVAL; GOVERNMENT REGULATION; GUIDELINES AS TOPIC; HISTORY, 20TH CENTURY; HISTORY, 21ST CENTURY; HUMANS; MODELS, STATISTICAL; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; SAMPLE SIZE; TREATMENT OUTCOME; UNITED STATES;

EID: 78249264147     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2010.514462     Document Type: Review

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