Blinded sample size re-estimation in equivalence testing

08/13/2019

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by   Ekkehard Glimm, et al.

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This paper investigates type I error violations that occur when blinded sample size reviews are applied in equivalence testing. We give a derivation which explains why such violations are more pronounced in equivalence testing than in the case of superiority testing. In addition, the amount of type I error inflation is quantified by simulation as well as by some theoretical considerations. Non-negligible type I error violations arise when blinded interim re-assessments of sample sizes are performed particularly if sample sizes are small, but within the range of what is practically relevant.