Noninferiority Clinical Trial

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A Noninferiority Clinical Trial is a Clinical Trial which primary objective is to show that the response to the investigational product (or new treatment) is not clinically inferior to a comparative agent.



References

2021

2017

$H_0:\mu_1-\mu_0\leq-\delta$ vs. $H_1:\mu_1-\mu_0>-\delta$ (5)
where $\delta \geq 0$ and is also called the margin of clinical significance which is usually small.

The non-inferiority of the treatment to the control can be easily understood form the alternative hypothesis. If the mean difference between the treatment and control group is greater than $\delta$, then the treatment is non-inferior to the control. Unlike the superiority trial, we don’t need the treatment to be better than the control.

2011

  1. Garret AD. Therapeutic equivalence: fallacies and falsification. Statist Med. 2003;22:741–762. doi: 10.1002/sim.1360.

2009