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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.

Show MeSH
A forest plot and M1.
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Related In: Results  -  Collection

License
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Figure 3: A forest plot and M1.

Mentions: The typical presentation of a meta-analysis shows a forest plot depicting the results of each trial, and then a summary statistic showing the estimated effect. Having completed this meta-analysis, the investigator calculates the 95% CI and finds what FDA calls M1, the effect size of the control therapy that will be assumed (Figure 3).


Through the looking glass: understanding non-inferiority.

Schumi J, Wittes JT - Trials (2011)

A forest plot and M1.
© Copyright Policy - open-access
Related In: Results  -  Collection

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

Figure 3: A forest plot and M1.
Mentions: The typical presentation of a meta-analysis shows a forest plot depicting the results of each trial, and then a summary statistic showing the estimated effect. Having completed this meta-analysis, the investigator calculates the 95% CI and finds what FDA calls M1, the effect size of the control therapy that will be assumed (Figure 3).

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