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Questions tagged [non-inferiority]

A non-inferiority study is designed to test whether one treatment is not worse than another.

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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 ...
Mathemagician777's user avatar
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Account for prevalence in sample size calculations?

I want to calculate the sample size for a retrospective non-inferiority study. I want to test if methodB has a sensitivity that is non-inferior to methodA in regards to detecting head traumas on ...
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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-...
user12541161's user avatar
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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 ...
Kate Atkinson's user avatar
4 votes
1 answer
99 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 ...
Kate Atkinson's user avatar
1 vote
0 answers
101 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 ...
Adrián Valls Carbó's user avatar
3 votes
2 answers
106 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 ...
user387320's user avatar
4 votes
2 answers
739 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-...
Seydou GORO's user avatar
3 votes
1 answer
3k 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 ...
Seydou GORO's user avatar
1 vote
0 answers
83 views

Sample size calculation for non-inferiority prospective observational study with paired nominal data?

I'm doing a diagnostic observational study, where doctors in two different fields (emergency physicians vs radiologists) try to diagnose same patient (paired sample). The question we are trying to ...
user375530's user avatar
1 vote
1 answer
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Stability of results in non-inferiority test in small sample size with rare events

I am working with a dataset including 65 participants, 35 in the control group and 30 in the experimental group. The objective is to assess wether the experimental group is non-inferior to the control ...
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Confidence level and alpha with two one-sided t-tests (TOST)

I'm making a non-inferiority study: two groups complete a test (where it is possible to score 0-30 points). I already have the test results for groupB. I want to investigate if groupA performs non-...
user12541161's user avatar
1 vote
0 answers
65 views

Do multiple measurements on each patient require mixed effect methods if the number of measurements per patient is the same?

For the purposes of this question, let's acknowledge that accuracy is not the best way to measure a model's performance, and that a proper scoring rule is best. However, the decision to use accuracy ...
Demetri Pananos's user avatar
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1 answer
266 views

Noninferiority test for nonparametric distributions -- which statistical test to use?

I'm trying to conduct a noninferiority test to determine whether one treatment is no worse than another. The distributions of the two populations are likely not normal, so I want to use a non-...
RedoxRxn's user avatar
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When switching from non-inferiority to superiority - is the adjustment for significance needed (confusion)?

On this blog: http://onbiostatistics.blogspot.com/2012/06/switching-from-non-inferiority-to.html which also cites the opinion of FDA and EMA we can read, that no adjustment is necessary. Could anyone ...
ContrarioAdAbs's user avatar
2 votes
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123 views

Sample size calculation for a non-inferiority RCT

I am planning to test the non-inferiority of a new resistance training program compared to the standard training program. The primary outcome will be maximal muscle strength that will be measured pre ...
Hadar Schwartz's user avatar
2 votes
1 answer
76 views

In clinical trials, why do we not always use Equivalence trials instead of superiority and non-inferiorty?

So I understand what these three types are aimed for, I know they answer different questions. However, why wouldn't we always use equivalence trials? I mean if for example were are comparing two drugs ...
Ammar Aldawoodyeh's user avatar
1 vote
1 answer
130 views

Non-inferiority test for Spearman correlation

Let's say I have the following data and want to test whether the Spearman's correlation is > 0.5 ...
thc's user avatar
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1 vote
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277 views

Sample size for non-Inferiority Tests for Two Survival Curves Using Cox’s Proportional Hazards, parameter specification of actual hazard ratio

I am looking into at trying to understand the parameter, "Actual Hazard Ratio", used in the following sample size calculation. Example 1 in the following pdf. https://ncss-wpengine.netdna-...
E_J's user avatar
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1 answer
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Best method for paired survival/time-to-event non-inferiority sample size calculation (using median survival time)?

I am trying to design a theoretical study in which one group of patients uses two wearable devices (i.e., every participant uses both devices) that gather information about their vitals, which is then ...
sceyence's user avatar
2 votes
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Non-inferiority testing for a $2 \times 2$ design when assay sensitivity is not achieved

Suppose we are testing the hypothesis: $$\mathcal{H}_0 : \pi_1 < \pi_0 + \delta$$ versus $$\mathcal{H}_0 : \pi_1 > \pi_0 + \delta$$ where $\delta$ is the non-inferiority margin. $\pi_1$ and $\...
AdamO's user avatar
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1 vote
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Defining terms in the specifications of a non-inferiority test

We wish to test the hypothesis that a treatment has efficacy $\pi_t$ that is non-inferior to control $\pi_c$. What do we call the non-inferiority boundary, call this $\pi_{t0}$, the threshold given by ...
AdamO's user avatar
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1 vote
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Cox proportional hazard (non-inferiority hypothesis testing) in R

I have researched this question for hours. Any help is appreciated. I am using the "survival package" in R with coxph function. I will illustrate with this example ...
AA AA's user avatar
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2 votes
0 answers
207 views

Non Parametric Multi-Group Non-Inferiority Testing

I have an experiment with 3 conditions. I am interested in showing evidence that the mean of one group is no worse than another. I believe this is called a multi-group non-inferior test. My data is ...
Wynand's user avatar
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2 votes
1 answer
173 views

Should we do a meta-analysis of non-inferiority trials?

Since non-inferiority trials are designed meticulously to achieve an effect size demonstrating no significant difference between treatments, so there may be certain essential differences in design of ...
Prabhakar's user avatar
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1 vote
1 answer
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Interpretations of Non-Inferiority

I'm having some trouble really groking non-inferiority for risk difference in a two sample binary proportion. Let $p_1$ be the risk of the outcome from the standard of care and let $p_2$ be the risk ...
Demetri Pananos's user avatar
2 votes
0 answers
171 views

help determining ROPE for bayesian multilevel probit model

I am having difficulty determining a justifiable region of practical equivalence (ROPE) for a parameter from a multilevel probit model Below is the posterior distribution for the fixed-effect of ...
bag2's user avatar
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3 votes
1 answer
353 views

Power analysis for non-inferiority study

I'm doing a power analysis for a non-inferiority study based on this calculation from "Sample size calculations in clinical research" by Chow, Shao, Wang, and Lokhnygina: $$ n = \frac{(z_{\alpha}+z_{\...
ved's user avatar
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Why does a non-inferiority design require a smaller sample size than a superiority design?

I understand that theoretically, because a non-inferiority design has a wider range of successful outcomes (equivalence or superiority) vs. a superiority design which only has one successful outcome, ...
Dylan Russell's user avatar
1 vote
1 answer
656 views

Non-inferiority margin and minimum detectable effect vs sample size

I am trying to understand why testing for non-inferiority requires pretty much the same sample size as testing for superiority (I assume the latter is the same as a one-sided test for a given MDE). I ...
iggy's user avatar
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3 votes
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88 views

Is there a less arbitrary way define the margin in non-inferiority and/or equivalence trials?

In a typical equivalence trial, the researcher defines some threshold below which the difference between two means is not considered practically meaningful. In a non-inferiority trial, the same kind ...
dmacfour's user avatar
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0 answers
101 views

Noninferiority in a multilevel model

I am working on a randomized trial in which patients were randomized to one of two groups and followed over time, they were assessed at 5 time points including baseline. The outcomes include ...
Peter Flom's user avatar
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1 vote
0 answers
304 views

Sample size estimation for superiority/non-inferiority study

I am trying to estimate sample size for a superiority/non-inferiority study between two diagnostic tests. I have the AUCs of Model0 (standard test) and Model1 (new test), and other required parameters....
nafs_nafs's user avatar
1 vote
0 answers
318 views

Sample size calculation for 3 arm study "non-inferiority design" and continuous endpoints

I need to do a sample size calculation for a 3 arm study. Something like mentioned HIER! The endpoint is a severity score. The score can take integer values from 0 to 100 points. (i would consider ...
Andre Elrico's user avatar
2 votes
1 answer
266 views

Inconclusive results in non-inferiority design

I am interested in how an inconclusive result occurs given the formal null and alternative hypotheses required for non-inferiority testing. I have pre-specified a noninferiority design comparing ...
Todd D's user avatar
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1 vote
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760 views

How to perform multiple noninferiority tests with linear mixed models?

I want to test a theory that predicts that certain measures are greater than or equal than others. Consequently, I want to perform noninferiority tests. Furthermore, I want to get rid of some ...
Tobias B.'s user avatar
  • 105
1 vote
1 answer
2k views

Determining Non-Inferiority with a 95% Confidence Interval

I have a sample of 1000 observations, divided into 2 groups: treatment and control (500 in each group). Each observation is dichotomous: 1 if an event occurred (bad event), and 0 if no event occurred. ...
user3275222's user avatar
4 votes
1 answer
201 views

Non-inferiority test and bootstrapping

Background: I am trying to show that my method is as good as or better than a previously published work in the field of Automatic Speech Recognition. Usually, in the literature people usually report ...
joapuipe's user avatar
11 votes
2 answers
565 views

Can we accept the null in noninferiority tests?

In a usual t-test of means, using the usual hypothesis testing methods, we either reject the null or fail to reject the null but we never accept the null. One reason for this is that if we got more ...
Peter Flom's user avatar
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1 vote
1 answer
72 views

Testing equivalence (mean stayed the same)

We have an app, where you post projects and we'll be running A/B test on new version of posting page. How do we ensure that the new version is not worse? We have 14 days of time to decide that. And ...
Matjaz Muhic's user avatar
9 votes
1 answer
2k views

Noninferiority Using Logistic Regression

From the paper Equivalence and Noninferiority Testing in Regression Models and Repeated-Measures Designs the following graphic is taken. I am interested in a non-inferiority test between two ...
B_Miner's user avatar
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7 votes
1 answer
423 views

Determine if two distributions are the same

I develop GNU Parallel. For each release I would like to test whether the version I am about to release has a memory leak. I can measure the memory usage. Unfortunately the usage varies slightly ...
Ole Tange's user avatar
  • 171
2 votes
1 answer
119 views

Estimating non-inferiority sample size

I'm projecting the number of patients needed for a clinical trial. Specifically, I'm using this model (https://www.sealedenvelope.com/power/binary-noninferior), and setting the variables as: (1) alpha ...
user90761's user avatar
5 votes
1 answer
4k views

Does statistically insignificant difference of means imply equality of means?

Suppose I have sets A and B of normally distributed data so that: A: mean=250, SD=200, N=25 B: mean=248, SD=200, N=20 Clearly, there is no statistically ...
numentar's user avatar
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2 votes
0 answers
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How to use a meta-analysis to assess the equivalence of two different procedures?

I'm making a comparison of two surgical procedures, and I want to know how I can analyze the data I have for a meta-analysis. The overall surgical procedure is the same, but some authors choose to ...
user20996's user avatar
1 vote
0 answers
135 views

Non-inferiority testing without normal approximation

I am performing a non-inferiority test on two binomial trials. I want to determine if my test proportion, pT, is not worse than my control, pC, by more than an amount d. Assuming nT trials of my test ...
Zapadus's user avatar
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5 votes
2 answers
16k views

One-sided Fisher's exact test and its complement

If a one-sided Fisher's exact test testing the null hypothesis that A is not superior to B has a p-value of 0.98, is it true that the Fisher's exact test p-value for the null hypothesis that B is not ...
pmgjones's user avatar
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