Understanding noninferiority trials

Research output: Contribution to journalReview article

43 Citations (Scopus)

Abstract

Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

Original languageEnglish
Pages (from-to)403-407
Number of pages5
JournalKorean Journal of Pediatrics
Volume55
Issue number11
DOIs
StatePublished - 26 Nov 2012

Fingerprint

Biomedical Technology
Therapeutics
Placebos

Keywords

  • Clinical trials
  • Controlled clinical trials
  • Noninferiority trial
  • Randomized controlled clinical trials

Cite this

@article{873000897ce042cf87b847c8258092a2,
title = "Understanding noninferiority trials",
abstract = "Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.",
keywords = "Clinical trials, Controlled clinical trials, Noninferiority trial, Randomized controlled clinical trials",
author = "Seokyung Hahn",
year = "2012",
month = "11",
day = "26",
doi = "10.3345/kjp.2012.55.11.403",
language = "English",
volume = "55",
pages = "403--407",
journal = "Korean Journal of Pediatrics",
issn = "1738-1061",
publisher = "Korean Pediatric Society",
number = "11",

}

Understanding noninferiority trials. / Hahn, Seokyung.

In: Korean Journal of Pediatrics, Vol. 55, No. 11, 26.11.2012, p. 403-407.

Research output: Contribution to journalReview article

TY - JOUR

T1 - Understanding noninferiority trials

AU - Hahn, Seokyung

PY - 2012/11/26

Y1 - 2012/11/26

N2 - Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

AB - Noninferiority trials test whether a new experimental treatment is not unacceptably less efficacious than an active control treatment already in use. With continuous improvements in health technologies, standard care, and clinical outcomes, the incremental benefits of newly developed treatments may be only marginal over existing treatments. Sometimes assigning patients to a placebo is unethical. In such circumstances, there has been increasing emphasis on the use of noninferiority trial designs. Noninferiority trials are more complex to design, conduct, and interpret than typical superiority trials. This paper reviews the concept of noninferiority trials and discusses some important issues related to them.

KW - Clinical trials

KW - Controlled clinical trials

KW - Noninferiority trial

KW - Randomized controlled clinical trials

UR - http://www.scopus.com/inward/record.url?scp=84869454881&partnerID=8YFLogxK

U2 - 10.3345/kjp.2012.55.11.403

DO - 10.3345/kjp.2012.55.11.403

M3 - Review article

C2 - 23227058

AN - SCOPUS:84869454881

VL - 55

SP - 403

EP - 407

JO - Korean Journal of Pediatrics

JF - Korean Journal of Pediatrics

SN - 1738-1061

IS - 11

ER -