The aim of a non-inferiority study is to prove that a new (generic) drug is NOT WORSE THAN the classic treatment (the brand). Fulfilling non-inferiority should never be interpreted those treatments are equal. An equivalence study is analyzed as TWO NON-INFERIORITY STUDIES; each aiming to prove that one treatment is not worse than the other.
Workshop items:
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Understand the difference between the superiority, the non-inferiority & the equivalence study
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Calculate the unilateral 95% & the bilateral 90% confidence intervals
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Choose the non-inferiority margin & the equivalence limit
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Calculate sample size
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Analyze by Intention to treat & per protocol
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Interpret the results & appreciate limitations
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