Abstract

Because one excludes in the sequential parallel comparison design (SPCD) both placebo responders and patients assigned to the experimental treatment in period 1 from comparison in period 2, test procedures for the SPCD may lose efficiency. Assuming a random effects logistic regression model, we evaluate the loss of efficiency by comparing power of the SPCD with those for the parallel groups design with repeated measurements (PGDRM), simple crossover design (SCD), and parallel group design (PGD). Based on Monte Carlo simulations, we find that the increase in efficiency of the SPCD by use of the PGDRM and SCD can be significant, especially when the variation of responses between patients is large. The SPCD can be, however, of use if the relative treatment effect on placebo non-responders is of our primary interest.

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