Non-inferiority in survival analysis

[BlueNose]

Dear all,

I am trying to design a study comparing two treatments, an experimental one and a standard of care. The outcome is success / failure, however the status will be checked in various followup times, making the analysis appropriate for survival analysis.

Today I have received some new information, making the primary objective more a non-inferiority one then a superiority. I have found a paper of Jung, Kang, McCall and Blumenstein from 2007, suggesting how to calculate the required sample size. I haven't tried it just yet, but will give it a try manually soon. While thinking about this whole issue, I have realized that even if I will succeed with the sample size calculations, I have no idea how to analyze the data in the future, since I don't know how to perform a non-inferiority test when it comes to the survival analysis.

As far as I understand, if HR denotes the hazard ratio, and HR0 denotes the non-inferiority margin, the null hypothesis is H0: HR>=HR0 vs. H1: HR<HR0

This is as far as I could go. My questions are:

1. Are these the correct hypotheses ?

2. If so, how do I make such an analysis with SAS, is there a special option ? Is there a macro ? In general, is there a guideline of how to analyze non-inferiority studies with SAS ?

Thank you in advance!

[liaot]

I have the syntax question regarding non-inferiority survival design using PROC POWER or PROC SEQDESIGN. The non-inferiority margin for HR should be greater than 1 if lower hazard is better. Can SAS provide an example codes?

[spirto]

Reviving this post from 2013 and 2016 to see if anyone has any updates/suggestions.

Does anyone know if SAS can calculate a non-inferiority sample size (via a proc or macro)?

Thanks

[Stormbreaker]

Hi All,

could someone please respond to the original question from Blue Nose? 

[mkeintz]

There are a couple of SAS papers that have "non-inferiority" in their titles.  I haven't read them.

At PHUSE 2020: 

Assessing Non-Inferiority and Equivalence from Survival Data 

And at SAS Global Forum 2020:

Testing Hypotheses for Equivalence and Non-inferiority with Binary and Survival Outcomes  

[Stormbreaker]

Hi Blue Nose,

Did you find a solution to this answer?