Challenges and regulatory experiences with non-inferiority trial design without placebo arm

Biometrical Journal

Volumn 51, Issue 2, 2009, Pages 324-334

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

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

Author keywords

Conditional type I error rate; Fixed margin method; Non inferiority margin; Synthesis method; Unconditional type I error rate

Indexed keywords

ERRORS;

'CURRENT; CONDITIONAL TYPE I ERROR RATE; FIXED MARGIN METHOD; NON-INFERIORITY; NON-INFERIORITY MARGIN; STATISTICAL INFERENCE; SYNTHESIS METHOD; TYPE I ERROR RATE; UNCONDITIONAL TYPE I ERROR RATE;

STATISTICAL METHODS;

PLACEBO;

ARTICLE; RANDOMIZED CONTROLLED TRIAL; STATISTICAL MODEL; STATISTICS;

MODELS, STATISTICAL; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 66349086534     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200800219     Document Type: Article

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