It has power advantage or sample size saving over the traditional group sequential test designed for testing either superiority only or non-inferiority only. Group sequential test procedures offer the.
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The proposed adaptive test strategy is valid in terms of having the type I error probability maintained at the targeted α level for both superiority and non-inferiority. Based on the concept of repeated significance tests, an empirical study may be planned in subsequent stages. When it is necessary to plan for testing the superiority and the non-inferiority hypotheses, we propose an adaptive group sequential closed test strategy by which the sample size is planned for testing superiority and is to be increased for showing non-inferiority given that it is deemed more plausible than superiority based on the observed sample path during the course of the trial. The difference is due in part to the fact that the sequential test ignores the total number of failures that occurred in each group, which the traditional \(Z\) test makes use of.
#GROUP SEQUENTIAL TESTING PDF#
maximized sequential probability ratio test (MaxSPRT PDF 22.
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![group sequential testing group sequential testing](http://ecx.images-amazon.com/images/I/41HKzZM%2BTqL._SY344_BO1,204,203,200_.jpg)
In a group sequential active controlled clinical trial, the study hypothesis may be a superiority hypothesis that an experimental treatment is more effective than the active control therapy or a non-inferiority hypothesis that the treatment is no worse than the active control within some non-inferiority range. If adaptation has occurred at an analysis <, replace +1,( ) in () by the new ෨ ( +1),, ෨( ) and apply the original group sequential testing boundary. The sequential test performs less efficiently at higher conversion rates, as demonstrated in the table below. than among the comparison group, the vaccine may be associated with an adverse event.