Abstract

With unblinded sample size adaptations the usual estimate such as the overall treatment difference can be biased and the usual confidence intervals may not have correct coverage probabilities. Thus, when providing naive (unadjusted) point estimates and/or confidence intervals in journals or reports, one must be aware of the poor behavior of these quantities. In adaptive designs, this is even more problematic because, for example, the coverage probability of a fixed sample confidence interval can decrease dramatically.

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