Design and analysis of crossover trials for investigating high-risk medical devices: A review.

Abstract

During evaluation of new investigational medical devices, the FDA recommends that investigators design a crossover clinical trial, in which the patients are arranged to cross over from one treatment arm to another. The FDA annually receives the premarket applications of investigational medical devices, in which sponsors design and conduct crossover trials as their confirmatory clinical trials for evaluating safety and effectiveness of the devices. This article reviews the use of crossover clinic