Types of Treatment Comparisons: Superiority vs. Non-Inferiority

Question 1

what are 3 ways to demonstrate efficacy?

Answer 1

superiority of the new treatment to the active control
non-inferiority of the new treatment to the active control
the equivalence of two treatments

Question 2

what is a superiority trial?

Answer 2

determines whether a clinically relevant difference exists between two interventions

Question 3

what is an equivalence trial?

Answer 3

determines whether a new treatment is neither worse nor netter than another established trial

Question 4

what is a non-inferiority trail?

Answer 4

determines whether a new treatment is not inferior to another established treatment

Question 5

how is the boundary between equivalence and inferiority determined?

Answer 5

the minimally clinically important difference between treatments in the primary endpoint, clinical judgement, and statistical considerations