A regulatory view on adaptive/flexible clinical trial design

Biometrical Journal

Volumn 48, Issue 4, 2006, Pages 565-573

  James Hung, H M ^a   O'Neill, Robert T ^a   Wang, Sue Jane ^a   Lawrence, John ^a  

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

Author keywords

Adaptive information design; Dropping a treatment arm; Non inferiority; Regulatory evaluation; Statistical efficiency; Statistical information; Superiority

Indexed keywords

PRODUCT DESIGN;

ADAPTIVE INFORMATION; ADAPTIVE INFORMATION DESIGN; CLINICAL TRIAL DESIGNS; DROPPING A TREATMENT ARM; INFORMATION DESIGN; NON-INFERIORITY; REGULATORY EVALUATION; STATISTICAL EFFICIENCY; STATISTICAL INFORMATION; SUPERIORITY;

EFFICIENCY;

EID: 33748519263     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200610229     Document Type: Review

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