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Non-inferiority trials are conducted to demonstrate whether a new treatment is not inferior to an existing treatment by more than a prespecified margin, known as the non-inferiority margin (δ). δ is thus a critical element in these studies and must be justifiable both statistically and clinically.1 We have recently argued that there should be a superiority margin similar to the non-inferiority margin in superiority trials.2 The current practice is that if 95% CI lies within the inferiority margin (δ) of the no-difference line, the drug is considered to be non-inferior. The drug is considered inferior only if the 95% CI lie outside the δ (figure 1).
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