A clinician’s guide to the assessment and interpretation of noninferiority trials for novel therapies
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A new paper published today in Open Medicine offers a guide to clinicians who need to evaluate the results of noninferiority trials. A noninferiority trial is an increasingly common type of study that seeks to demonstrate that an experimental therapy is not worse than an active control. However, clinicians and residents accustomed to interpreting conventional superiority trial results may not even notice that they are dealing with a different type of trial. The present work aims to provide some guidance to clinicians and residents alike.
The paper by Simon Oczkowski appears online on Open Medicine.
“I think for clinicians on the frontlines and for residents, who are all very comfortable interpreting randomized trials for superiority, noninferiority trials can be tricky. You’re at risk of being misled or misleading your patients. You need to recognize that a trial has a noninferiority design.”
Key to properly interpreting results from such a trial for patients is looking carefully at the numbers before recommending a similar but perhaps more convenient treatment or one that may have fewer side-effects: the “noninferior” therapy.
“A noninferiority trial is trying to show that the new treatment is not worse than a certain amount [the noninferiority margin],” Oczkowski explains. Since the therapy might in fact be worse by that percentage loss of efficacy, it is important for clinicians to look carefully at the margins used. They must also pay close attention to the outcomes that “noninferiority” margins actually represent in a given study. These can range from relatively minor worsened outcomes to outcomes such as death. Without looking carefully at the numbers, clinicians may simply note that a treatment was found to be “noninferior”, and miss the actual risk that exists from the novel therapy.
“It can be falsely reassuring.”
Simon J.W. Oczkowski, MD, FRCPC, is an internal medicine specialist and critical care fellow training in the Division of Critical Care at McMaster University, Hamilton, Ontario.
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