Introduction to case-crossover study designs for drug-drug interaction

Abstract

This article introduces the basic concept of a novel 6-parameter model case-crossover study with active comparator design. While case-crossover study design eliminates time-invariant confounding, the 6-parameter model as a modified version also allows studying the effect of drug initiation patterns between two interacting drugs. The implementation of the case-crossover study is illustrated, including the generation of the dataset for data analysis and performing the 6-parameter model using conditional logistic regression. Potential interpretation framework is proposed using eight combinations based on three scenarios shown in the results of the 6-parameters case-crossover study design.