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Sample Size Recalculation in Internal Pilot Study Designs: A Review

✍ Scribed by Tim Friede; Meinhard Kieser


Publisher
John Wiley and Sons
Year
2006
Tongue
English
Weight
180 KB
Volume
48
Category
Article
ISSN
0323-3847

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✦ Synopsis


Abstract

The adequacy of sample size is important to clinical trials. In the planning phase of a trial, however, the investigators are often quite uncertain about the sizes of parameters which are needed for sample size calculations. A solution to this problem is mid‐course recalculation of the sample size during the ongoing trial. In internal pilot study designs, nuisance parameters are estimated on the basis of interim data and the sample size is adjusted accordingly. This review attempts to give an overview on the available methods. It is written not only for biometricians who are already familar with the the topic and wish to update their knowledge but also for users new to the subject. (© 2006 WILEY‐VCH Verlag GmbH & Co. KGaA, Weinheim)


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