Assay sensitivity is a property of a clinical trial defined as the ability of a trial to distinguish an effective treatment from a less effective or ineffective intervention. Without assay sensitivity, a trial is not internally valid and is not capable of comparing the efficacy of two interventions.
Lack of assay sensitivity has different implications for trials intended to show a difference greater than zero between interventions (superiority tr...
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Assay sensitivity is a property of a clinical trial defined as the ability of a trial to distinguish an effective treatment from a less effective or ineffective intervention. Without assay sensitivity, a trial is not internally valid and is not capable of comparing the efficacy of two interventions.
Lack of assay sensitivity has different implications for trials intended to show a difference greater than zero between interventions (superiority trials) and trials intended to show non-inferiority. Non-inferiority trials attempt to rule out some margin of inferiority between a test and control intervention i.e rule out that the test intervention is no worse than the control intervention by a chosen amount.
If a trial intended to demonstrate efficacy by showing superiority of a test intervention to control lacks assay sensitivity, it will fail to show that the test intervention is superior and will fail to lead to a conclusion of efficacy.
In contrast, if a trial intended to demonstrate...
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