Challenges in implementing adaptive designs: Comments on the viewpoints expressed by regulatory statisticians

Biometrical Journal

Volumn 48, Issue 4, 2006, Pages 591-597

  Gallo, Paul ^a   Maurer, Willi ^a  

^a NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Adaptive designs; Adaptive information design; Adaptive study designs; Biostatistics; Clinical trial simulation; Dropping a treatment arm; Experimental design; FDA critical path; Guidance development; Missing data; Multiple end points; Non inferiority

Indexed keywords

DESIGN OF EXPERIMENTS;

ADAPTIVE DESIGNS; ADAPTIVE INFORMATION; ADAPTIVE INFORMATION DESIGN; ADAPTIVE STUDY DESIGN; BIOSTATISTIC; CLINICAL TRIAL; CLINICAL TRIAL SIMULATION; CRITICAL PATHS; DROPPING A TREATMENT ARM; END-POINTS; FDA CRITICAL PATH; GUIDANCE DEVELOPMENT; INFORMATION DESIGN; MISSING DATA; MULTIPLE END-POINT; NON-INFERIORITY; STUDY DESIGN;

MEDICAL APPLICATIONS;

EID: 33748524529     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200610250     Document Type: Review

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