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Blinded Sample Size Reestimation in Non‐Inferiority Trials with Binary Endpoints
Author(s) -
Friede Tim,
Mitchell Charles,
MüllerVelten Günther
Publication year - 2007
Publication title -
biometrical journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.108
H-Index - 63
eISSN - 1521-4036
pISSN - 0323-3847
DOI - 10.1002/bimj.200610373
Subject(s) - sample size determination , statistics , type i and type ii errors , binary number , mathematics , statistical power , sample (material) , outcome (game theory) , econometrics , chemistry , chromatography , arithmetic , mathematical economics
Sample size calculations in the planning of clinical trials depend on good estimates of the model parameters involved. When the estimates of these parameters have a high degree of uncertainty attached to them, it is advantageous to reestimate the sample size after an internal pilot study. For non‐inferiority trials with binary outcome we compare the performance of Type I error rate and power between fixed‐size designs and designs with sample size reestimation. The latter design shows itself to be effective in correcting sample size and power of the tests when misspecification of nuisance parameters occurs with the former design. (© 2007 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)