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JAMA Guide to Statistics and Methods |

Noninferiority Trials Is a New Treatment Almost as Effective as Another?

Amy H. Kaji, MD, PhD1,2,3; Roger J. Lewis, MD, PhD1,2,3,4
[+] Author Affiliations
1Department of Emergency Medicine, Harbor-UCLA Medical Center, Torrance, California
2David Geffen School of Medicine at UCLA, Torrance, California
3Los Angeles Biomedical Research Institute, Los Angeles, California
4Berry Consultants, LLC
JAMA. 2015;313(23):2371-2372. doi:10.1001/jama.2015.6645.
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This Guide to Statistics and Methods describes the reasons for conducting a noninferiority trial and how to analyze and interpret the results from a trial that did.

Sometimes the goal of comparing a new treatment with a standard treatment is not to find an approach that is more effective but to find a therapy that has other advantages, such as lower cost, fewer adverse effects, or greater convenience with at least similar efficacy to the standard treatment. With other advantages, a treatment that is almost as effective as a standard treatment might be preferred in practice or for some patients. The purpose of a noninferiority trial is to rigorously evaluate a new treatment against an accepted and effective treatment with the goal of demonstrating that it is at least almost as good (ie, not inferior).

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Two Different Possible Results of a Noninferiority Trial, Summarized by 1-Tailed Confidence Intervals for the Relative Efficacy of the New and Active-Control Treatments

In the top example, the lower limit of the confidence interval lies to the left of the noninferiority margin, demonstrating that the results are consistent with greater inferiority (worse efficacy) than allowed by the noninferiority margin. Thus, the new treatment may be inferior and noninferiority is not demonstrated. In the lower example, the lower limit of the confidence interval lies to the right of the noninferiority margin, demonstrating noninferiority of the new treatment relative to the active-control treatment. The overall result of the trial is defined by the lower limit of the 1-sided confidence interval rather than by the point estimate for the treatment effect, so point estimates are not shown.

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