Two-stage adaptive strategy for superiority and non-inferiority hypotheses in active controlled clinical trials

Statistics in Medicine

Volumn 23, Issue 18, 2004, Pages 2781-2798

  Shih, Weichung J ^a   Quan, Hui ^b   Li, Gang ^c  

^a UNIVERSITY OF MEDICINE AND DENTISTRY OF NEW JERSEY   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

^c Organon Pharmaceuticals USA Inc   (United States)

Author keywords

Active control; Adaptive design; Equivalence; Non inferiority; Sample size

Indexed keywords

CAPECITABINE; FLUOROURACIL; FOLINIC ACID; PLACEBO;

ANALYTICAL ERROR; ARTICLE; CLINICAL TRIAL; COLORECTAL CANCER; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DECISION MAKING; EXPERIMENTAL DESIGN; EXPERIMENTAL THERAPY; HUMAN; HYPOTHESIS; MAJOR CLINICAL STUDY; METHODOLOGY; PRACTICE GUIDELINE; RANDOMIZED CONTROLLED TRIAL; RELIABILITY; SAMPLE SIZE; STATISTICAL ANALYSIS; TREATMENT OUTCOME; TREATMENT PLANNING;

CONTROLLED CLINICAL TRIALS; HUMANS; MODELS, STATISTICAL; NEOPLASMS; RESEARCH DESIGN; UNITED STATES;

EID: 4444345588     PISSN: 02776715     EISSN: None     Source Type: Journal    
DOI: 10.1002/sim.1877     Document Type: Article

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