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Describe when a NI study is appropriate
•Equivalence Trial: Designed to show if a new therapy is similar to a control therapy
Non inferiority trial: Designed to show a new therapy is not worse than the control therapy by more than an acceptable amount
•Use when unethical to compare to a palcebo
What is Hh and Ha in Non inferiority
H0: New therapy- Control therapy >= Margin
HA:New therapy- control therapy < Margin
Margin is what would be unacceptably worse
What is a type 1 error in non inferiority
Found new agent to be non inferior when it actually is inferior
If Upper bound of 95% confidence interval crosses margin….
then it is unacceptably worse
Is ITT or Per protovol less conservative in NI
ITT is less conservative in NI, and we look at per protocol first
Can NI be interpreted to mean “the same” “equivalent” “ no difference”
NO! >:(
six supplemental CONSORT questions used to evaluate an NI trial
1)Non inferiority margin
2)Control
3)Sample size
4)Confidence Interval
5)Analysis of the results
6)Conclusion
Non inferiority margin considerations
What is the non inferiority margin ?
Was it established a priori?
Is it justified as being clinicallt relevant and sensible?
Control
What is the control?
Has the control been proven to be efficacious vs placebo?
Confidence interval
Is a two sided confidence interval presented around the difference between the intervention and control and presented in relationship to the non inferiority margin
Analysis of the results
Is it presented for both per protocol and ITT?
Conclusion
Does it reference the non inferiority margin?
FACTS eval for NI studies
1)Formualte null hypothesis
2)Assess the NI margin
3)Compare the ITT and PP analysis
4)Translate CIs graphically
5)Summarize the clinical relevance of results
Translate CIs graphicallt
1)NI margin
2)Type of CIs assocaited with primary endpoint
3)Numerical results of primary endpoint
Proper phrasing for non inferiority
“Met the criteria for non inferiority because the upper bound of the 95% confidence interval did not cross the non inferiority margin of ___”