Superiority Clinical Trial

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A Superiority Clinical Trial is a Clinical Trial which primary objective is to show that the response to the investigational product (or new treatment) is clinically superior to a comparative agent.



References

2021

2017

$H_0:\mu_1-\mu_0\leq \delta$ vs. $H_1:\mu_1-\mu_0>\delta$

(1)
where $\delta \geq$(...)

The value $\delta$ in (1) is called margin of clinical significance.

2009

Noninferiority designs differ from standard superiority trials in several fundamental ways. The null hypothesis of standard superiority trials is that there is no true difference between the interventions. In other words, unless strong evidence is found indicating the superiority of one intervention over the other, the default conclusion is that no treatment difference exists.