Non-inferiority Trial

Background Movie:

Based on my taste, 我不是药神 Drug Deal/Dying to Survive is one of the best movies in 2018. It was based on a true story that some cancer patients use a kind of cheap Indian medicine (Veenat 100) as a substitution of the authentic Novartis Glivec 400 to prolong their lives.
Besides the touching story, Veenat 100 is a textbook sample of Non-Inferiority Trials compared to Glivec400.


While most clinical trials want to demonstrate the superiority of a new treatment compared to a placebo or existing drug, we also have clinical trials called Non-Inferiority Trials( the new treatment is “as good as” the old treatment) has one or more advantages while the efficacy is within the Non-inferiority margin:

-Fewer side effects

-Easier to consume

Less expensive (Veenat 100 vs Glivec 400)

Key Concept:

Non-Inferiority Margin, Risk Ratio

We used 1.1 as the Non-Inferiority Margin, but the specific number would vary in each clinical trial design.

Risk Ratio=New/Old
risk ratio <1: Superiority the New drug is better than the Old drug in efficacy.

risk ratio=1: the New drug is the same as the Old drug in efficacy.

risk ratio>1: the New drug is worse than the Old drug in efficacy.


Happy studying and wish everyone is healthy!

Thanks 77 for sharing the Harvard Catalyst class with me.





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