Evidence map›Paper›PMID 40193075›Full record

SynthesisJAMA network open2025

Reporting of Noninferiority Margins on ClinicalTrials.gov: A Systematic Review.

Camille Reinaud, Sandra Mavoungou, David Hajage, Chloé Lieng, Deivanes Rajendrabose, Diane Ferreira, Jules Blanchard, Agathe Turpin, Agnès Dechartres

Abstract readSystematic Review
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in JAMA network open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

Camille ReinaudSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
Sandra MavoungouSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
David HajageSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
Chloé LiengSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
Deivanes RajendraboseSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
Diane FerreiraSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
Jules BlanchardSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
Agathe TurpinSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.
Agnès DechartresSorbonne Université, Institut National de la Santé et de la Recherche Médicale, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Pitié-Salpêtrière, Département de Santé Publique, Centre de Pharmacoépidémiologie de l'AP-HP (Cephepi), Paris, France.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Importance: The noninferiority margin is a key methodological parameter in noninferiority trials that affects both sample size calculation and interpretation of results. Objective: To assess (1) the reporting of the noninferiority margin on ClinicalTrials.gov, including when it was reported; (2) the consistency of the noninferiority margin between registration and publication; and (3) the reporting of the noninferiority margin at registration in a sample of recent trials. Evidence Review: This systematic review was conducted in 2 stages. Stage 1 involved identifying all noninferiority trials registered on ClinicalTrials.gov with a primary completion date of January 1, 2010, to January 1, 2015, and searching for corresponding publications. Stage 2 included all noninferiority trials registered between January 1, 2022, and June 30, 2023. Two reviewers independently and manually extracted methodological characteristics related to the noninferiority design for each trial at registration and, when available, in results posted on ClinicalTrials.gov and in publications. The time points for reporting the noninferiority margin were at registration, during the patient enrollment phase (between start date and primary completion date), after the primary completion date, or in results posted. Findings: Among the 266 trials completed between 2010 and 2015, only 8 (3.0%) reported the noninferiority margin at registration. The noninferiority margin was reported after registration for 31 of 266 trials (11.7%), with 11 (4.1%) reporting it during the patient enrollment phase and 20 (7.5%) reporting it after the primary completion date. Of the 132 trials with results posted on ClinicalTrials.gov, 79 (59.8%) reported the noninferiority margin. A corresponding publication was found for 208 trials, with 196 (94.2%) reporting the noninferiority margin. For 5 trials reporting the margin at both registration and in publication, the noninferiority margin was consistent in both sources. Among the 327 noninferiority trials first posted between 2022 and 2023, 30 (9.2%) reported the noninferiority margin at registration. Conclusions and Relevance: In this systematic review, the reporting of the noninferiority margin on ClinicalTrials.gov was low. Mandatory reporting of the design and the noninferiority margin at registration could enhance the transparency and favor more reliable results.

Indexed as

Clinical Trials as TopicEquivalence Trials as TopicRegistriesResearch DesignHumansSample Size

Identifiers

PMID40193075
PMCPMC11976490

What OpenQuestion holds

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Registered trials

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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.