Consistency of Treatment Effect across Regions in Multiregional Clinical Trials, Part 1: Design Considerations

Drug Information Journal

Volumn 45, Issue 5, 2011, Pages 595-602

  Chen, Joshua ^a   Quan, Hui ^b   Gallo, Paul ^c   Menjoge, Shailendra ^c   Luo, Xiaolong ^c   Tanaka, Yoko ^c   Li, Gang ^c   Ouyang, S Peter ^c   Binkowitz, Bruce ^a   Ibia, Ekopimo ^a   Talerico, Steven ^c   Ikeda, Kimitoshi ^c  

^a MERCK RESEARCH LABORATORIES   (United States)

^b Global Health Outcomes and Market Access   (United States)

^c Novartis ^*  (Japan)

Author keywords

Consistency; Multiregional clinical trial; PhRMA; Study design

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL (TOPIC); FALSE POSITIVE RESULT; HEALTH CARE ORGANIZATION; HEALTH CARE SYSTEM; HUMAN; HYPOTHESIS; MEDICAL DOCUMENTATION; MULTICENTER STUDY (TOPIC); NULL HYPOTHESIS; PRIORITY JOURNAL; QUALITATIVE RESEARCH; QUANTITATIVE ANALYSIS; RANDOMIZATION; REGIONALIZATION; RISK; RISK FACTOR; SAMPLE SIZE; STATISTICAL ANALYSIS; STRATIFIED SAMPLE; STUDY DESIGN; TREATMENT OUTCOME; TREATMENT PLANNING;

EID: 84862241734     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286151104500609     Document Type: Article

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