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The increasing interest in subpopulation analysis has led to the development of various new trial designs and analysis methods in the fields of personalized medicine and targeted therapies. In this paper, subpopulations are defined in terms of an accumulation of disjoint population subsets and will therefore be called composite populations. The proposed trial design is applicable to any set of composite...
The formula of Fleiss and Cuzick (1979) to estimate the intraclass correlation coefficient is applied to reduce the task of sample size calculation for clustered data with binary outcome. It is demonstrated that this approach reduces the complexity of sample size calculation to the determination of the null and alternative hypothesis and the formulation of the quantitative influence of the belonging...