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This document reviews internal pilot study designs for recalculating sample size during clinical trials. It discusses how initial sample size is calculated based on estimates of nuisance parameters like variance. During the trial, data from an internal pilot sample is used to re-estimate nuisance parameters and recalculate the required sample size. Methods that require unblinding treatment groups to recalculate sample size are described, as are blinded methods. The document provides analytical results on ho

Author

nelson huayta

Language

EN