The hypotheses of the noninferiority test are
However, we do want to say a few more things about non-inferiority trials based on some recent questions and readings.
The hypotheses for this noninferiority study are
The following examples illustrate designing noninferiority studies and conducting noninferiority tests. Further in-depth discussion of noninferiority and equivalence testing, and several examples, can be found in .
“An equivalence/noninferiority study should be designed to minimize the possibility that a new therapy that is found to be equivalent/noninferior to the current therapy can be nonsuperior to a placebo.”
to prove the null hypothesis of non-inferiority, ..
Confidence intervals (CIs) should be evaluated to determine superiority. Some evaluators seem to suggest that superiority can be declared only if the CIs are wholly above the Delta. Schumi et al. express their opinion that you can declare superiority if the confidence interval for the new treatment is above the line of no difference (i.e.., is statistically significant). They state, “The calculated CI does not know whether its purpose is to judge superiority or non-inferiority. If it sits wholly above zero [or 1, depending upon the measure of outcome], then it has shown superiority.” EMA would seem to agree. We agree as well. If one wishes to take a more conservative approach, one method we recommend is to judge whether the Delta seems clinically reasonable (you should always do this) and if not, establishing your own through clinical judgment. Then determine if the entire CI meets or exceeds what you deem to be clinically meaningful. To us, this method satisfies both approaches and makes practical and clinical sense.
Is it acceptable to claim non-inferiority trial superiority? It depends. This area is controversial with some saying no and some saying it depends. However, there is agreement amongst those on the “it depends” side that it generally should not be done due to validity issues as described above.
Superiority, Equivalence and Non-Inferiority - ASQ
i) State the null alternative hypotheses, explaining your choice.
ii)Calculate the P-value
iii)Represent your results on a graph that marks clearly the rejection and non rejection regions. What do you concludes.
iv) Construct a 90% confidence interval around the March sample mean. Comment on the, relative to your conclusion in part (iii)
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hypothesis of non-inferiority ..
Evaluating Equivalence and Noninferiority Trials
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use
Hypothesis Testing in Equivalence and Noninferiority Trials
30/11/2017 · Testing Superiority and Non-Inferiority Hypotheses in Active Controlled ..
Non Inferiority & Equivalence Testing - Scribd
Non Inferiority & Equivalence Testing - Download as PDF File (.pdf), Text File (.txt) or read online.
Understanding the null hypothesis (H 0) in non-inferiority ..
US Department of Health and Human Services, Food and Drug Administration: Guidance for Industry Non-Inferiority Clinical Trials (DRAFT). 2010.
Can we accept the null in noninferiority tests
European Agency for the Evaluation of Medicinal Products Committee for Proprietary Medicinal Products (CPMP): Points to Consider on Switching Between Superiority and Non-Inferiority. 2000.
Noninferiority hypotheses and choice of noninferiority …
For studies with two independent samples of normally distributed data, you can use the TWOSAMPLEMEANS statement in PROC POWER to compute the power or sample size needed for a noninferiority test. For example, suppose a new, less expensive treatment is designed to lower blood pressure. Two groups of patients with similar demographics will be randomly assigned to receive either the standard treatment or the new treatment. The mean blood pressure is expected to be 120 in the standard treatment group, and 120 or less under the new treatment. A difference in mean blood pressure of 5 or less is considered clinically unimportant for this comparison. The expected common standard deviation in the groups is 12. You want to determine the required sample size in each group for a range of average blood pressure values under the new treatment in order to conclude that the new treatment is not inferior to the standard at α=0.05 and with power=0.9.
Hypothesis: One-Sided Non-Inferiority / Superiority
PROC TTEST is used to conduct the noninferiority test. These statements produce a lower-sided, 95% confidence interval for the difference in mean blood pressure. If the upper confidence limit is below the noninferiority margin, then the null hypothesis of inferiority is rejected. This upper limit is equivalent to the upper limit of a two-sided, 90% confidence interval. The PLOTS= option produces a graph of the lower-sided confidence interval and includes a vertical reference line at the inferiority margin, 5.
δ=-10%, to test for non-inferiority.
The results indicate that the drug is not substantially inferior to the target (p=0.0005). The significance of the test is verified by the lower limit of the 90% confidence interval (0.9178) being greater than the noninferiority limit (0.9 = 0.91 - .01).
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