Non-inferiority Study Design: Application to Clinical Trials.

Plast Reconstr Surg

Professor of Surgery, Section of Plastic Surgery, Department of Surgery, University of Michigan Medical School, Ann Arbor, MI.

Published: July 2024

Non-inferiority trials, a distinct category within randomized controlled trials, are garnering increased attention in medical research. Their unique and evolving role comes to the forefront in scenarios where new treatments, despite not surpassing the efficacy of an existing standard, bring additional benefits like reduced side effects, enhanced compliance, or cost savings. As the field of surgery witnesses a growing number of published non-inferiority trials, it becomes imperative for surgeons to grasp the intricacies of this trial type to accurately decipher and interpret their outcomes.

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http://dx.doi.org/10.1097/PRS.0000000000011633DOI Listing

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