Equivalence and noninferiority

Philip McCarthy; Benjamin Acton; Jessica Maxwell

doi:10.1016/B978-0-323-90300-4.00033-1

Equivalence and noninferiority

Philip McCarthy, Benjamin Acton, Jessica Maxwell

Research output: Chapter in Book/Report/Conference proceeding › Chapter

Abstract

Equivalence and noninferiority trials are becoming more common in the medical literature. Because many disease processes have well-established therapeutic regimens, equivalence and noninferiority trials are helpful tools to evaluate novel therapeutics. This allows the researcher to compare to the standard of care rather than placebo, which in many instances would be undesirable or even unethical. Understanding and implementing proper study design, as well as avoiding potential pitfalls, are important to obtain results with clinical relevance and credibility.

Original language	English (US)
Title of host publication	Handbook for Designing and Conducting Clinical and Translational Surgery
Publisher	Elsevier
Pages	339-345
Number of pages	7
ISBN (Electronic)	9780323903004
DOIs	https://doi.org/10.1016/B978-0-323-90300-4.00033-1
State	Published - Jan 1 2023

Keywords

Equivalence
Equivalence margin
Noninferiority
TOST
Two one-sided test

ASJC Scopus subject areas

General Medicine

Access to Document

10.1016/B978-0-323-90300-4.00033-1

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AB - Equivalence and noninferiority trials are becoming more common in the medical literature. Because many disease processes have well-established therapeutic regimens, equivalence and noninferiority trials are helpful tools to evaluate novel therapeutics. This allows the researcher to compare to the standard of care rather than placebo, which in many instances would be undesirable or even unethical. Understanding and implementing proper study design, as well as avoiding potential pitfalls, are important to obtain results with clinical relevance and credibility.

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KW - Equivalence margin

KW - Noninferiority

KW - TOST

KW - Two one-sided test

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PB - Elsevier

ER -

Equivalence and noninferiority

Abstract

Keywords

ASJC Scopus subject areas

Access to Document

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