The Superiority of Patient Engagement and Shared Decision-Making in Noninferiority Trials

Excerpt

The Users’ Guides to the Medical Literature has been a bible to many general internists seeking to develop skills in critically appraising the medical literature and delivering evidence-based care. However, the most recently published guide on how to use a noninferiority trial struck a discordant note.1 The topic was timely, given the recent spate of noninferiority articles being published in the literature—a PubMed search of “noninferiority” and “clinical trials” identified 126 citations in 2012. Clinicians accustomed to reading studies to determine whether a new treatment is more effective than a standard treatment or placebo in preventing morbid events or death have found the concept of noninferiority to be perplexing. The rationale for conducting noninferiority studies is that a new treatment would be valued if it were not much worse than a standard treatment in preventing adverse clinical outcomes, and was also safer, more convenient, or cheaper. The guide provided a helpful framework for understanding and interpreting these studies, but fell short in addressing applicability. …