Adaptive Clinical Trials: Overview of Phase III Designs and Challenges

Therapeutic Innovation and Regulatory Science

Volumn 48, Issue 1, 2014, Pages 31-40

  Maca, Jeff ^a   Dragalin, Vladimir ^b   Gallo, Paul ^c  

^a IQVIA   (United States)

^b ICON PLC   (United Kingdom)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

adaptive trial design; confirmatory studies; enrichment design; sample size re estimation; seamless phase II III

Indexed keywords

ADAPTIVE CLINICAL TRIAL; ARTICLE; CLINICAL DEVELOPMENT PLAN; CLINICAL RESEARCH; CLINICAL TRIAL (TOPIC); CONFIDENCE INTERVAL; DRUG MONITORING; EFFECT SIZE; FOLLOW UP; HUMAN; INFORMATION PROCESSING; METHODOLOGY; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRACTICE GUIDELINE; PRIORITY JOURNAL; SAMPLE SIZE; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; STUDY DESIGN;

EID: 84891533066     PISSN: 21684790     EISSN: 21649200     Source Type: Journal    
DOI: 10.1177/2168479013507436     Document Type: Article

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