Group-sequential three-arm noninferiority clinical trial designs

Journal of Biopharmaceutical Statistics

Volumn 27, Issue 1, 2017, Pages 1-24

  Ochiai, Toshimitsu ^a,b   Hamasaki, Toshimitsu ^b,c   Evans, Scott R ^d   Asakura, Koko ^b,c   Ohno, Yuko ^b  

^a SHIONOGI AND CO LTD   (Japan)

^b OSAKA UNIVERSITY GRADUATE SCHOOL OF MEDICINE   (Japan)

^c NATIONAL CEREBRAL AND CARDIOVASCULAR CENTER   (Japan)

^d CENTER FOR BIOSTATISTICS IN AIDS RESEARCH   (United States)

Author keywords

Assay sensitivity; average sample number; Cui Hung Wang statistics; fixed margin approach; fraction approach; maximum sample size; sample size recalculation; Type I error

Indexed keywords

ALGORITHM; ARTICLE; CONTROLLED STUDY; DECISION MAKING; INFORMATION; MATHEMATICAL ANALYSIS; NORMAL DISTRIBUTION; NULL HYPOTHESIS; PRIORITY JOURNAL; REFERENCE VALUE; SAMPLE SIZE; SEQUENTIAL ANALYSIS; SIMULATION; STUDY DESIGN; THREE ARM NONINFERIORITY; VARIANCE; EQUIVALENCE TRIAL (TOPIC); HUMAN; METHODOLOGY;

EQUIVALENCE TRIALS AS TOPIC; HUMANS; RESEARCH DESIGN; SAMPLE SIZE;

EID: 84967139718     PISSN: 10543406     EISSN: 15205711     Source Type: Journal    
DOI: 10.1080/10543406.2016.1148710     Document Type: Article

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