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Non-inferiority trial


A trial design aiming to assess whether a test product is not inferior to a comparator.

Non-inferiority is defined as efficacy that is no lower than a small pre-specified value, known as the non-inferiority margin. This margin must be specified in advance and based on clinical and statistical data; choice of non-inferiority margin can be challenging, and regulatory agencies have published extensive guidance to inform trial design.