Interpreting and Applying Study Results Flashcards
Define Equivalence Trial
Confirm the absence of a meaningful difference between treatments
Define Non-inferiority Trial
Show that one treatment is not worse than a comparator by a pre-specified margin
Define Superiority Trial
Show that one treatment is better than a comparator
Equivalence trial
Objective is to show they are not different
Superiority Trial
Show that the investigational treatment is better than the comparator
Non-inferiority Trial DOES NOT mean
Two treatments are equal
New drug isn’t inferior to the comparator
New drug is efficacious
Non-inferiority Trial DOES mean
it is not worse than the comparatory by a certain pre-specified margin
Considerations
Selection of comparator
Margin of non-inferiority
Sensitivity of the assay/measurements
Data analysis: ITT and PP should suppor the same conclusion
Define Active Comparators
Established efficacy
ID indications/conditions
Widely use
Placebo control
Helps to establish internal validity
Non-inferiority margins
Should be justified by the authors
Should involve FDA consultation
Should be determined a priori
Why use non-inferiority?
Placebo control is not possible at all
Investigators do not expect better efficacy
Non-inferiority to superiority
Trial appropriately designed
Statistical analysis appropriate for both
ITT analysis is used to show superiority
Superiority to non-inferiority
Trail appropriate
Non-inferiority margin predefined and justified
Both ITT and PP analysis support
Sensitive enough to detect a difference if one exists
Evidence to support
