Applications of noninferiority trials in interventional pulmonology

Noninferiority trials are a potentially powerful study design in interventional pulmonology (IP). These studies are an extension of the randomized control trial, but, instead of seeking to establish the superiority of a novel intervention, the goal is to demonstrate that the efficacy of the new intervention is "similar enough" to an established therapy to be clinically useful.1 Because of this more limited goal, these studies have been maligned as contributing to the approval of "me-too" drugs-newer, more expensive, therapies that are no more efficacious than an established therapy.2 However, noninferiority designs may be very effective for addressing specific types of research questions encountered in IP. The goal of this article is to outline the basic construction of a noninferiority trial and address several situations, with examples, where noninferiority designs may be a good choice.