Blinded sample size reestimation in non-inferiority trials with binary endpoints

Biometrical Journal

Volumn 49, Issue 6, 2007, Pages 903-916

  Friede, Tim ^a   Mitchell, Charles ^b   Müller Velten, Günther ^c  

^a UNIVERSITY OF WARWICK   (United Kingdom)

^b ETH ZURICH   (Switzerland)

^c NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Clinical trials; Internal pilot study; Non inferiority study; Nuisance parameter; Sample size reestimation

Indexed keywords

ERROR ANALYSIS; PARAMETER ESTIMATION;

CLINICAL TRIAL; INTERNAL PILOT STUDY; NON-INFERIORITY; NON-INFERIORITY STUDY; NUISANCE PARAMETER; PILOT STUDIES; POWER; SAMPLE SIZE REESTIMATION; SAMPLE SIZES; SIZE CALCULATIONS;

UNCERTAINTY ANALYSIS;

EID: 38049151165     PISSN: 03233847     EISSN: 15214036     Source Type: Journal    
DOI: 10.1002/bimj.200610373     Document Type: Article

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