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Sequential boundaries approach in clinical trials with unequal allocation ratios

Sequential boundaries approach in clinical trials with unequal allocation ratios

Abstract Background In clinical trials, both unequal randomization design and sequential analyses have ethical and economic advantages. In the single-stage-design (SSD), however, if the sample size is not adjusted based on unequal randomization, the power of the trial will decrease, whereas with sequential analysis the power will always remain constant. …