ABSTRACT

In the previous chapter, formulas for sample size calculation for comparing proportions were derived based on asymptotic approximations. In practice, sample sizes for some clinical trials such as phase II cancer trials are usually small and, hence, the formulas given in the previous chapter may not be useful. In this chapter, our primary focus is placed on procedures for sample size calculation based on exact tests for small samples. Unlike the tests based on asymptotic distribution, the power functions of the exact tests usually do not have explicit forms. Hence, exact formulas for sample size calculation cannot be obtained. However, the sample size can be obtained numerically by greedy search over the sample space.