Journal
JOURNAL OF BIOPHARMACEUTICAL STATISTICS
Volume 15, Issue 4, Pages 559-574Publisher
TAYLOR & FRANCIS INC
DOI: 10.1081/BIP-200062852
Keywords
adaptive methods; ancillary statistic; blinding; continuous outcome; clinical trials; conditioning; correlation; dichotomous outcome; independence; internal pilot study; lumping; pooling; power; restricted design; unrestricted design
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Sample size calculations are important and difficult in clinical trails because they depend on the nuisance parameter and treatment effect. Recently, much attention has been focused on two-stage methods whereby the first stage constitutes an internal pilot study used to estimate parameters and revise the final sample size. This paper reviews two-stage methods based on estimation of nuisance parameters in either a continuous or dichotomous outcome setting.
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