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Testing Statistical Hypotheses of Equivalence and Noninferiority
Abstract
While continuing to focus on methods of testing for two-sided equivalence, Testing Statistical Hypotheses of Equivalence and Noninferiority, Second Edition gives much more attention to noninferiority testing. It covers a spectrum of equivalence testing problems of both types, ranging from a one-sample problem with normally distributed observations
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“The non-inferiority margin was defined a priori (in the grant application) by a strict and small margin of tolerance for non-inferiority of 10%, or a ε of 0.36 [53], p.16 which, for example, represents a difference in change between the two conditions of no more than 10% on the primary outcome measure.”
In the citing paper
“The sample size was established a priori based on a power analysis for non-inferiority trials [53,54].”
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“…0 +- 0.3) the observed data can be compared against an equivalence range and researchers can test if a meaningful effect is absent (Hauck & Anderson, 1984; Kruschke, 2018; Rogers, Howard, & Vessey, 1993; Serlin & Lapsley, 1985; Spiegelhalter, Freedman, & Parmar, 1994; Wellek, 2010; Westlake, 1972).”
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“…difference in the number of oocytes (−5) between groups was determined by calculating statistically as recommended for the non-inferiority margin (Wellek, 2010) and the lower limit of the one-sided 97.5% CI for the difference was −0.25, even though the pre-defined margin seemed to be set wider…”
MethodInfluentialBinder, N., Möllenhoff, K., Sigle, A., et al. (2022) · Statistics in Medicine · doi:10.1002/sim.9481 · Cited by 4
“Then, the problem is methodologically related to the meanwhile classical problem of bioequivalence, which aims at demonstrating the similarity between two pharmacokinetic profiles by considering the area under the curve or the maximum concentrations of the two curves (see the monographs Chow and Liu [8], Wellek [9] am…”
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“…them to (1) define the set of effect sizes that are 'practically equivalent' to the null and (2) refute the hypothesis that the population effect size is larger in absolute value than the upper and lower bounds of practical equivalence (Lakens et al., 2018; Weber & Popova, 2012; Wellek, 2010).”
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“Specifically, Wellek [14] proposed n adjustment of the ANOVA F test based on the variance of he standardized means.”
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“change point analysis, where one does not test for exact equality, but only looks for \similarity" or a \relevant" dierence. This concept is well known in biostatistics [see, for example, Wellek (2010)] but has also been used to investigate the similarity of distribution functions [see Alvarez Esteban et al.…”
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“11 The choice of this equivalence margin is in line with the discussion of what a large odds ratio recommended by Chen et al. 12 This equivalence margin was chosen before performing statistical analysis.”
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“The latter often accompany statistical null hypothesis tests; for a detailed discussion of equivalence tests the reader is referred to Wellek (2010), for example.”
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“As this lies below the upper liberal equivalence margin of .85 suggested by Wellek (2010), it is concluded that the preloading rates of males and females are equivalent for meaningful purposes.”
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“noted as "in this paper. If the null hypothesis is rejected one can then claim at a pre-specied signicance level that, in the previous example, the two treatments have an equivalent eect [see Wellek (2010)]. Equivalence testing is often used in regulatory settings because it reverses the burden of proof compared…”
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“ecent literature margins for the survival dierence are frequently chosen between 0:1 and 0:2, for detailed discussions on that topic we refer to D’Agostino Sr et al. (2003); Da Silva et al. (2009); Wellek (2010), who also investigate the correspondence between and the hazard ratio threshold ". We now use the cond…”
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“The noninferiority trials derived predominantly from the field of medication (Kaji & Lewis, 2015; Wellek, 2010).”
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“Based on the interval-inclusion principle [30]”
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“Also notice that this concept is of great relevance in some applications, such as bioequivalence in Biostatistics (see, for example, [29]).”
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Background
Metadata
- Authors
- Wellek, S.
- Corresponding author
- Wellek, Stefan
- ORCID
- Wellek, Stefan
- Venue
- Chapman & Hall/CRC eBooks
- Publisher
- Chapman and Hall/CRC
- Published
- 2010-06-24
- OpenAlex
- W2480935928
- Cited by
- 548
- References
- 0
- Citations by year
- 2026: 23 · 2025: 19 · 2024: 31 · 2023: 30 · 2022: 50 · 2021: 57 · 2020: 69 · 2019: 49 · 2018: 55 · 2017: 30 · 2016: 30 · 2015: 37 · 2014: 19 · 2013: 24 · 2012: 19
- FWCI
- 4.76
- Type
- book
- Language
- en
- Open access
- closed
- Locations
- Chapman & Hall/CRC eBooks (publishedVersion)
- CERN Document Server (European Organization for Nuclear Research) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Physical Sciences › Mathematics › Statistics and Probability › Probability and Statistical Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods and Bayesian Inference
- Keywords
- equivalence testing, non-inferiority testing, hypothesis testing, one-sample problem, clinical trials
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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