Ohrn, F. and Jennison, C., 2010. Optimal group-sequential designs for simultaneous testing of superiority and non-inferiority. Statistics in Medicine, 29 (7-8), pp. 743-759.
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Confirmatory clinical trials comparing the efficacy of a new treatment with an active control typically aim at demonstrating either superiority or non-inferiority. In the latter case, the objective is to show that the experimental treatment is not worse than the active control by more than a pre-specified non-inferiority margin. We consider two classes of group-sequential designs that combine the superiority and non-inferiority objectives: non-adaptive designs with fixed group sizes and adaptive designs where future group sizes may be based on the observed treatment effect. For both classes, we derive group-sequential designs meeting error probability constraints that have the lowest possible expected sample size averaged over a set of values of the treatment effect. These optimized designs provide an efficient means of reducing expected sample size under a range of treatment effects, even when the separate objectives of proving superiority and non-inferiority would require quite different fixed sample sizes. We also present error spending versions of group-sequential designs that are easily implementable and can handle unpredictable group sizes or information levels. We find the adaptive choice of group sizes to yield some modest efficiency gains; alternatively, expected sample size may be reduced by adding another interim analysis to a non-adaptive group-sequential design.
|Item Type ||Articles|
|Creators||Ohrn, F.and Jennison, C.|
|Uncontrolled Keywords||superiority,non-inferiority,clinical trial,adaptive re-design,decision theory,group-sequential test|
|Departments||Faculty of Science > Mathematical Sciences|
|Additional Information||29th Annual Conference of the International Society for Clinical Biostatistics, Aug 17-21, 2008. Copenhagen, Denmark.|
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