Noninferiority trials imply a trade-off between a loss in efficacy of a standard treatment in exchange for other benefits of a new therapy (eg, easier to use, less costly, fewer adverse effects). Noninferiority studies are increasingly used for comparisons of novel treatments with standard active controls. However, this design is complex; clinicians, patients, and even investigators often have difficulty fully grasping this methodology. The importance of anticipated benefits is often not explicitly characterized, and the threshold for the necessary trade-off, called the noninferiority margin (ΔNI), is sometimes chosen arbitrarily without integrating patient values and preferences.
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Acuna SA, Chesney TR, Baxter NN. Incorporating Patient Preferences in Noninferiority Trials. JAMA. 2019;322(4):305–306. doi:10.1001/jama.2019.7059
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