15.11 - Analysis - More Complex Designs

The analysis of continuous, binary, and time-to-event outcome data from a design more complex than the 2 × 2 crossover is not as straightforward as that for the 2 × 2 crossover design.

With respect to a continuous outcome, the analysis involves a mixed-effects linear model (SAS PROC MIXED) to account for the repeated measurements that yield period, sequence, and carryover effects and to model the various sources of intra-patient and inter-patient variability.

With respect to a binary outcome, the analysis involves generalized estimating equations (SAS PROC GENMOD) to account for the repeated measurements that yield period, sequence, and carryover effects and to model the various sources of intra-patient and inter-patient variability.

In either case, with a design more complex than the 2 × 2 crossover, extensive modeling is required.