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Through the looking glass: understanding non-inferiority.

Schumi J, Wittes JT - Trials (2011)

Bottom Line: Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use.This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.

View Article: PubMed Central - HTML - PubMed

Affiliation: Statistics Collaborative, Inc, Washington DC 20036, USA. jennifer@statcollab.com

ABSTRACT
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.

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The role of Δ in superiority, equivalence and non-inferiority trials.
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Figure 1: The role of Δ in superiority, equivalence and non-inferiority trials.

Mentions: A non-inferiority experiment, by contrast, tries to show that the new intervention is not 'inferior' to the previous one, or, more precisely, that the new intervention is 'not unacceptably worse' than the intervention used as the control. Thus the hypothesis seems backwards, in a sense, as this hypothesis is not '' at all. Instead, it states that the new treatment is worse than the old by more than -Δ, where -Δ is the 'non-inferiority margin'. The alternative hypothesis states that the difference in the effect between the new and old interventions is less than -Δ (Figure 1). In the inverted world of non-inferiority, the alternative hypothesis seems '', whereas the hypothesis includes a specified treatment difference of -Δ. Here, -Δ is an integral part not only of the design, as with γ in superiority trials, but of the analysis as well, a role that γ does not play in superiority trials.


Through the looking glass: understanding non-inferiority.

Schumi J, Wittes JT - Trials (2011)

The role of Δ in superiority, equivalence and non-inferiority trials.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3113981&req=5

Figure 1: The role of Δ in superiority, equivalence and non-inferiority trials.
Mentions: A non-inferiority experiment, by contrast, tries to show that the new intervention is not 'inferior' to the previous one, or, more precisely, that the new intervention is 'not unacceptably worse' than the intervention used as the control. Thus the hypothesis seems backwards, in a sense, as this hypothesis is not '' at all. Instead, it states that the new treatment is worse than the old by more than -Δ, where -Δ is the 'non-inferiority margin'. The alternative hypothesis states that the difference in the effect between the new and old interventions is less than -Δ (Figure 1). In the inverted world of non-inferiority, the alternative hypothesis seems '', whereas the hypothesis includes a specified treatment difference of -Δ. Here, -Δ is an integral part not only of the design, as with γ in superiority trials, but of the analysis as well, a role that γ does not play in superiority trials.

Bottom Line: Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use.This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.

View Article: PubMed Central - HTML - PubMed

Affiliation: Statistics Collaborative, Inc, Washington DC 20036, USA. jennifer@statcollab.com

ABSTRACT
Non-inferiority trials test whether a new product is not unacceptably worse than a product already in use. This paper introduces concepts related to non-inferiority, and discusses the regulatory views of both the European Medicines Agency and the United States Food and Drug Administration.

Show MeSH