Considerations for crossover design in clinical study

Abstract

This article introduces a crossover design that is often used in clinical studies, with the advantage of comparing treatment effects within one study subject. In particular, the advantages and disadvantages of the two-period, two-sequence crossover design (2 × 2 or AB/BA crossover design), which is widely used in clinical practice, are identified, and the elements necessary for analysis are introduced. This article explains the carryover effect, period effect, sequence effect, and period-by-treatment interaction in a crossover design and examines the analysis commands of SAS along with example data. After confirming the carryover effect using a general linear model, the treatment effect is analyzed using a linear mixed effect model.

Keywords

• biomedical research
• carryover effect
• crossover design
• linear mixed effect model
• statistics
• washout period