Two-stage group sequential design of the study. The null hypothesis and the alternative hypothesis were set at H0: P ≤ P0 ( = 0.3) vs. H1: P ≥ P1 (= 0.5). Since 18 of the 30 initial subjects showed responses, the clinical study was terminated at the first stage with the conclusion that Genexol-PM was effective
The study used a two-stage group sequential design [ 14 ], with 90%
power to detect a response rate of 50% and <5% chance of
continuing the trial if the response was <30% (Fig. 1 ).
The current study used a two-stage group sequential design for
sample size calculation (Fig. 1 ) [ 14 ].
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