Blinded sample size re-estimation raises the type I error rate in equivalence and non-inferiority tests, with peaks around 6.3 percent for small interim samples, and can be controlled by minimum and maximum sample size caps.
Sample size reassessment in non-inferiority trials: internal pilot study designs with ANCOVA
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Blinded sample size re-estimation in equivalence testing
Blinded sample size re-estimation raises the type I error rate in equivalence and non-inferiority tests, with peaks around 6.3 percent for small interim samples, and can be controlled by minimum and maximum sample size caps.