This paper examines 83 medical device noninferiority clinical trials published in the New England Journal of Medicine,the Lancet,and Journal of the American Medical Association over the past 20 years.It introduces and analyzes the current status of noninferiority margin setting.The paper recommends a straightforward way of setting the noninferiority margin using a percentage of the positive control group's expectation,with the percent margin not exceeding 50%.This is especially crucial when the expectation in the control group is greater than 10%,and if exceeded,there should be sufficient justification.
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