A multistage analysis strategy for a clinical trial to assess successively more stringent criteria for a primary endpoint with a low event rate

Pharmaceutical Statistics

Volumn 12, Issue 2, 2013, Pages 65-73

  Li, Siying ^a   Hussey, Michael A ^a   Schwartz, Todd A ^a   Koch, Gary G ^a  

^a The University of North Carolina at Chapel Hill   (United States)

Author keywords

adaptive design; interim analyses; multiple comparisons; noninferiority; Poisson sample size method

Indexed keywords

ANTIDIABETIC AGENT;

ALTERNATIVE HYPOTHESIS; ANALYTICAL ERROR; ARTICLE; BINOMIAL DISTRIBUTION; CARDIOVASCULAR RISK; CLINICAL ASSESSMENT; CLINICAL TRIAL (TOPIC); CLUSTER ANALYSIS; CRITERION VARIABLE; DISEASE SIMULATION; DRUG EFFICACY; HEART DISEASE; HUMAN; NON INSULIN DEPENDENT DIABETES MELLITUS; NORMAL DISTRIBUTION; NULL HYPOTHESIS; PRACTICE GUIDELINE; RISK ASSESSMENT; SAMPLE SIZE;

ENDPOINT DETERMINATION; HUMANS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; SAMPLE SIZE; TREATMENT OUTCOME;

EID: 84874971690     PISSN: 15391604     EISSN: 15391612     Source Type: Journal    
DOI: 10.1002/pst.1554     Document Type: Article

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