super-superiority
Polish translation: super przewaga (ang. super-superiority, istotność kliniczna z dolną granicą przedziału ufności ...
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| 13:40 Jul 26, 2019 |
| English to Polish translations [PRO] Medical - Medical: Pharmaceuticals | |||||||
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|  Selected response from: Frank Szmulowicz, Ph. D. United States Local time: 08:14 | ||||||
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| 2 | super przewaga (ang. super-superiority, istotność kliniczna z dolną granicą przedziału ufności ... |
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Answers
11 hrs confidence: 
super przewaga (ang. super-superiority, istotność kliniczna z dolną granicą przedziału ufności ... Explanation: super przewaga (ang. super-superiority, istotność kliniczna z dolną granicą przedziału ufności efektu leczenia większą od minimalnie znaczącej różnicy klinicznej) Większość badań klinicznych, w tym również prób w dziedzinie onkologii, projektowana jest w celu wykazania przewagi (superiority) ocenianej interwencji nad obecnie stosowanymi terapiami lub brakiem leczenia https://journals.viamedica.pl/oncology_in_clinical_practice/... W odpowiedzi na to pytanie należy odnieść się do hipotezy badawczej sformułowanej w badaniu i wynikającej z niej kalkulacji wielkości próby. Po pierwsze badania mogą dowodzić wyższości (ang. superiority), równoważności (ang. equivalence) lub faktu, iż oceniana technologia nie jest gorsza niż porównywana (ang. non-inferiority) https://eu.cmkp.edu.pl/css_bart/dok_eu/Elementy oceny organi... |
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Reference comments
1 hr peer agreement (net): +1 |
| Reference: super-superiority Reference information: In the planning of a superiority trial, it is very important to calculate the sample size of the study to ensure adequate power with appropriate control of the Type I error to detect a statistical significant difference that is also clinically significant. However, clinical significance is often not clearly defined. Additionally, sometimes the observed treatment effect is statistically significant but the difference (and its confidence interval estimate) might not be clinically meaningful. In an effort to avoid different interpretations of the study results later in the review process, some clinical trials (i.e., some medical device trials) require super-superiority, that is, the lower bound of the confidence interval for the treatment effect has to be greater than a minimal clinically meaningful difference. To meet this requirement, the sample size of the clinical trial might have to increase substantially. Clinicians consider super-superiority trials as problem solvers. Interestingly, statisticians might have different view of its use. This roundtable will discuss the super-superiority trial, its implication and alternative approaches. - https://ww2.amstat.org/meetings/fdaworkshop/index.cfm?fuseac... |
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1 hr |
| Reference: super-superiority Reference information: One potential approach to assess clinical relevance is to define a clinically relevant effect, and test the null hypothesis that the true effect is of this size or less versus the hypothesis that the true effect is greater than the clinically relevant effect. For example, suppose that the clinical endpoint is a continuous variable, X, such that larger values represent better efficacy, and that there is interest in the mean difference in this endpoint, μ, between the experimental treatment and the control. Note that X could represent a measurement taken at the conclusion of the trial or a change in that measurement from its baseline value. The typical null hypothesis (assuming one-sided testing) is that of no difference, or μ ≤ 0, versus the alternative hypothesis μ > 0. However, if one were to define a minimum clinically important difference, μ0, then one could test the null hypothesis μ ≤ μ0 versus the alternative hypothesis μ > μ0. This hypothesis is sometimes referred to as "super superiority," and a statistically significant result in this case would imply both statistical significance and clinical relevance. However, the "super superiority" null hypothesis is not frequently used in practice, probably due to concerns with decreased power. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2164942/ |
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