Addressing Challenges and Opportunities of “Less Well-Understood” Adaptive Designs

Therapeutic Innovation and Regulatory Science

Volumn 51, Issue 1, 2017, Pages 60-68

  He, Weili ^a   Gallo, Paul ^b   Miller, Eva ^c   Jemiai, Yannis ^d   Maca, Jeff ^e   Koury, Ken ^a   Fan, Xiaoyin Frank ^f   Jiang, Qi ^g   Wang, Cunshan ^h   Lin, Min ⁱ  

^a MERCK RESEARCH LABORATORIES   (United States)

^b NOVARTIS PHARMA AG   (Switzerland)

^c Cytel ^*  (United States)

^d Cytel Corporation   (United States)

^e IQVIA   (United States)

^f NOVARTIS INSTITUTES FOR BIOMEDICAL RESEARCH   (United States)

^g AMGEN INC   (United States)

^h PFIZER INC   (United States)

ⁱ CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

adaptive trials; data monitoring committee; phase II III seamless trial; sample size reassessment; Type I error

Indexed keywords

ANALYTICAL ERROR; ARTICLE; CLINICAL RESEARCH; DECISION MAKING; FOOD AND DRUG ADMINISTRATION; HUMAN; PATIENT SELECTION; PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; SAMPLE SIZE; STATISTICAL BIAS; STUDY DESIGN; ADAPTIVE CLINICAL TRIAL; PROFESSIONAL STANDARD;

EID: 85009444691     PISSN: 21684790     EISSN: 21684804     Source Type: Journal    
DOI: 10.1177/2168479016663265     Document Type: Article

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