Evidence map›Paper›PMID 28252213›Full record

ArticleBritish journal of clinical pharmacology2017

Defining the noninferiority margin and analysing noninferiority: An overview.

Turki A Althunian, Anthonius de Boer, Rolf H H Groenwold, Olaf H Klungel

2 registry-linked trialsAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in British journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 92 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
92citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04189133 phase2unknown statusnot on this mapstarted 2022, after this paper: background citation

Pharmacodynamics and Safety of Human Recombinant Luteinising Hormone in Hypogonadotropic Hypogonadal Men

TypeinterventionalSponsorAzienda Ospedaliero-Universitaria di ModenaRan2022 to 2026Enrolled32ConditionsAcquired Hypogonadotropic HypogonadismArmsLutropin alfa, Human chorionic gonadotropin
NCT06452134 phase4unknown statusnot on this mapstarted 2024, after this paper: background citation

Evaluation the Effect of Coenzyme Q10 on Tissue Healing Process in Patients Undergoing Wisdom Tooth Extraction in the City of Sanandaj-Iran in 1402: a Double-blinded Clinical Trial Study

TypeinterventionalSponsorZahra NejatiRan2024 to 2025Enrolled70ConditionsMolar, Third, Temporomandibular Joint Disorders, Dry Socket, Coenzyme Q10ArmsCoenzyme Q10 100 MG Oral Tablet, Placebo
3 · Its place in the literature

Who cites it

92 citing papers in PubMed, 5 syntheses or guidelines pooled it.

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  9. Immunogenicity and safety of co-administeredFrontiers in immunology · 2026
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  13. Addressing Mental Health Symptoms Among COVID-19 Healthcare Workers: A Heart Rate Variability Biofeedback Pilot Study.Stress and health : journal of the International Society for the Investigation of Stress · 2024
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32 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

Turki A AlthunianDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, P.O.Box 80082, 3508, TB, Utrecht, The Netherlands.
Anthonius de BoerDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, P.O.Box 80082, 3508, TB, Utrecht, The Netherlands.
Rolf H H GroenwoldDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, P.O.Box 80082, 3508, TB, Utrecht, The Netherlands.
Olaf H KlungelDivision of Pharmacoepidemiology and Clinical Pharmacology, Utrecht University, P.O.Box 80082, 3508, TB, Utrecht, The Netherlands.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Noninferiority trials are used to assess whether the effect of a new drug is not worse than an active comparator by more than a noninferiority margin. If the difference between the new drug and the active comparator does not exceed this prespecified margin, noninferiority can be concluded. This margin must be specified based on clinical and statistical reasoning; however, it is considered as one of the most challenging steps in the design of noninferiority trials. Regulators recommend that the margin should be defined based on the historical evidence of the active comparator (the latter is often the well-established standard treatment of the disease), which can be performed by different approaches. There are several factors and assumptions that need to be accounted for during the process of defining the margin and during the analysis of noninferiority. Three methods are commonly used to analyse noninferiority trials: the fixed-margin method; the point-estimate method; and the synthesis method. This article provides an overview of analysing noninferiority and choosing the noninferiority margin.

Indexed as

Equivalence Trials as TopicModels, StatisticalResearch DesignDrug TherapyHumansTreatment Outcomebiostatisticsclinical trialsdrug regulationmethodologyrandomized controlled trials

Identifiers

PMID28252213
PMCPMC5510081

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.