Questions tagged [non-inferiority]
A non-inferiority study is designed to test whether one treatment is not worse than another.
53 questions
0 votes
1 answer
142 views
Comparing multiple groups to a reference group
I would like to compare several groups to a reference group, with the main idea being to show that the other groups are not inferior to the reference. Ideally, I would also like to test for ...
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3 votes
1 answer
94 views
Nonparametric test to compare deviation from a constant in a clinical trial
Following up on a previous question, thank you for your great suggestions! First the initial problem, than two curveballs for the wicked. We are currently designing a two-arm randomized clinical trial ...
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1 vote
0 answers
83 views
Are the formulas for non-inferiority trials the same as thise for superiority trials, just changing the denominator and the alpha value?
I have not found a way to perform my non-inferiority power calculations without simulations. Specifically, I'm interested in the within-between interaction parameter in a repeated-measure setting (...
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5 votes
2 answers
277 views
Non-inferiority vs. t-test when benchmarking a new implant to a predicate?
I’m benchmarking a new orthopaedic implant against a predicate device using a mechanical pull-out test. Sample size is small (n = 7 per group), which is common in orthopaedic biomechanics. Instead of ...
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8 votes
1 answer
255 views
Survival non inferiority trial sample size calculation
I have been trying to estimate sample size required for a non - inferiority trial with a survival outcome (time to treatment failure). I am using this online tool; https://riskcalc.org/samplesize/ As ...
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3 votes
2 answers
200 views
Primary outcomes in a non-inferiority clinical trial
Is it possible to have 2 primary outcomes in a non-inferiority clinical trial? And choose the sample size based on the largest one, if we have defined the same non-inferiority margin for both outcomes....
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0 votes
1 answer
121 views
Non-inferiority clinical trial
Based on a previous clinical trial study, we considered the margin of equivalency to be 10% in our non-inferiority clinical trial. The distribution of our primary outcome in non-normal. The ...
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3 votes
1 answer
250 views
How to analyse a non-inferiority trial using GEE in R?
I'm trying to analyse a non-inferiority trial in R. Since there are correlated observations and a population averaged interpretation seems fine, I want to use GEE. To illustrate my problem, I will use ...
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1 vote
0 answers
124 views
Sample size calculation for paired binary proportion - non-inferiority study?
I want to conduct a retrospective study, validating an algorithm. My data will be something like the following: id doctor prediction 1 0 0 2 1 1 ... ... ... n 0 1 My study design is non-inferiority, ...
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0 votes
1 answer
93 views
ANOVA is significant but also demonstrates non-inferiority
I have data that is looking at comparing a cheap (T) to expensive (V) ultrasound device with the hopes that the cheap is the same as expensive. There was 4 different examiners that used 4 different ...
4 votes
1 answer
168 views
Statistical test for nominal data, multiple variables and within-subject design in R
I have run a study comparing if a cheap ultrasound device (T) is as efficient at determining osteophytes as an expensive device (V). There was four examiners who reviewed each participant (ID) and ...
1 vote
0 answers
180 views
How to calculate p-value from non-inferiority study after OR?
I am conducting a study in which I test two different treatments A and B. The outcome is binary (success, fail). We want to demonstrate if treatment B is non-inferior to A with a margin of the ...
3 votes
2 answers
266 views
Is this explanation of a Non-Inferiority Margin Correct?
I'm relatively new to the field of biostats and was reading up on Non-Inferiority Trials and Margins and came across this explanation which is tripping me off a bit. "For example, the oral ...
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4 votes
2 answers
1k views
How to properly analyze a non-inferiority study
In my study I try to show that treatment A is not inferior to treatment B. With a delta margin of tolerance =-2. I had discussed the subject in a previous post, of which here is the link. For two-...
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4 votes
1 answer
4k views
How to calculate p.value for non inferiority study with R?
I'll give a little background on my study. It is a non-inferiority study. We have to show that treatment A is non-inferior to treatment B with a delta acceptability margin of -2 for the outcome. The ...
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