Exploring different objectives in non-inferiority trials

Non-inferiority clinical trials conventionally try to show that a new treatment is not appreciably worse than an existing treatment (as the control arm) by a specific amount, known as the non-inferiority margin.1 Non-inferiority trials have become more common because the emphasis is on finding new treatments that overcome drawbacks, such as side effects or length of treatment, that could make these new treatments attractive to clinicians managing patients. The additional benefits are frequently not directly assessed as part of the trial,2 however, and are more commonly implicit rather than clearly articulated.Not considering these additional benefits as part of designing an adequately powered trial has two related risks. Firstly, a new intervention with substantial additional benefits that only just fails to achieve conventional non-inferiority compared with the standard of care could be dismissed by policy makers without any consideration of these benefits and how they would translate into real world use….
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