Evidence map›Paper›PMID 39630768›Full record

ArticleRevista da Associacao Medica Brasileira (1992)2024

Conclusions of clinical trials assessing monoclonal antibodies and sponsored by pharmaceutical industry: a meta-research study.

Rachel Campos Ornelas, Débora de Souza Pazini, Rafael Leite Pacheco, Ana Luiza Cabrera Martimbianco, Rachel Riera

Abstract read
In one paragraph

Article in Revista da Associacao Medica Brasileira (1992), 2024. 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

5 authors.

Rachel Campos OrnelasUniversidade Federal de Juiz de Fora - Governador Valadares (MG), Brazil.ORCID http://orcid.org/0000-0003-3878-4720
Débora de Souza PaziniUniversidade Federal de Juiz de Fora - Governador Valadares (MG), Brazil.ORCID http://orcid.org/0000-0003-0595-4420
Rafael Leite PachecoHospital Sírio-Libanês - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-1676-6428
Ana Luiza Cabrera MartimbiancoHospital Sírio-Libanês - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-4361-4526
Rachel RieraHospital Sírio-Libanês - São Paulo (SP), Brazil.ORCID http://orcid.org/0000-0002-9522-1871

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThe objective of this study was to describe and critically appraise the conclusions of randomized clinical trials assessing monoclonal antibodies sponsored by the pharmaceutical industry.

methodsThis is a meta-research study on conclusions' characteristics of randomized clinical trials with monoclonal antibodies as interventions sponsored by the pharmaceutical industry.

resultsA total of 82 publications were considered. Notably, 79.3% (65/82) of the trials were fully funded by the pharmaceutical industry, and sponsors had data and publishing rights in 70.7% (58/82). Among the fully sponsored studies, 78.5% (51/65) presented conclusions with a drug-favorable direction of the effect, and 30.8% (20/65) made some recommendations for clinical practice, of which 95% (19/20) were favorable to the drug. In relation to the partially funded studies, drug-favorable direction of effect was present in 68.8% (11/16) of conclusions, and 18.8% (3/16) recommended the drug for the practice, in which 66.7% (2/3) favored the drug. Positive direction of effect was more present in trials in which the sponsor owned data and publication (81.0%; 47/58), compared to trials where the funder did not (63.3%; 14/22). Only 13.4% (11/82) of included studies recognize the uncertainty in the estimates in the conclusions, and 37.4% (31/82) had a statement regarding the need for future studies.

conclusionsMost of the included randomized clinical trials on monoclonal antibodies funded by the industry concluded a drug-favorable direction of effect. Recommendations for practice were common, while recognition of uncertainty and statements regarding the need for future studies were less frequently present in the conclusion.

Indexed as

Antibodies, MonoclonalDrug IndustryRandomized Controlled Trials as TopicResearch Support as TopicConflict of InterestHumansAntibodies, Monoclonal

Identifiers

PMID39630768
PMCPMC11639547

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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.