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Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals

BACKGROUND: Publication bias is generally ascribed to authors and sponsors failing to submit studies with negative results, but may also occur after submission. We evaluated whether submitted manuscripts on randomized controlled trials (RCTs) with drugs are more likely to be accepted if they report...

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Autores principales: van Lent, Marlies, Overbeke, John, Out, Henk Jan
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Public Library of Science 2014
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4130599/
https://www.ncbi.nlm.nih.gov/pubmed/25118182
http://dx.doi.org/10.1371/journal.pone.0104846
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author van Lent, Marlies
Overbeke, John
Out, Henk Jan
author_facet van Lent, Marlies
Overbeke, John
Out, Henk Jan
author_sort van Lent, Marlies
collection PubMed
description BACKGROUND: Publication bias is generally ascribed to authors and sponsors failing to submit studies with negative results, but may also occur after submission. We evaluated whether submitted manuscripts on randomized controlled trials (RCTs) with drugs are more likely to be accepted if they report positive results. METHODS: Manuscripts submitted from January 2010 through April 2012 to one general medical journal (BMJ) and seven specialty journals (Annals of the Rheumatic Diseases, British Journal of Ophthalmology, Gut, Heart, Thorax, Diabetologia, and Journal of Hepatology) were included, if at least one study arm assessed the efficacy or safety of a drug and a statistical test was used to evaluate treatment effects. Publication status was retrospectively retrieved from submission systems or provided by journals. Sponsorship and trial results were extracted from manuscripts and classified according to predefined criteria. Main outcome measure was acceptance for publication. RESULTS: Of 15,972 manuscripts submitted, 472 (3.0%) were drug RCTs, of which 98 (20.8%) were published. Among submitted drug RCTs, 287 (60.8%) had positive and 185 (39.2%) negative results. Of these, 60 (20.9%) and 38 (20.5%), respectively, were published. Manuscripts on non-industry trials (n = 213) reported positive results in 138 (64.8%) manuscripts, compared to 71 (47.7%) on industry-supported trials (n = 149), and 78 (70.9%) on industry-sponsored trials (n = 110). Twenty-seven (12.7%) non-industry trials were published, compared to 27 (18.1%) industry-supported and 44 (40.0%) industry-sponsored trials. After adjustment for other trial characteristics, manuscripts reporting positive results were not more likely to be published (OR, 1.00; 95% CI, 0.61 to 1.66). Submission to specialty journals, sample size, multicentre status, journal impact factor, and corresponding authors from Europe or US were significantly associated with publication. CONCLUSIONS: For the selected journals, there was no tendency to preferably publish manuscripts on drug RCTs that reported positive results, suggesting that publication bias may occur mainly prior to submission.
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spelling pubmed-41305992014-08-14 Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals van Lent, Marlies Overbeke, John Out, Henk Jan PLoS One Research Article BACKGROUND: Publication bias is generally ascribed to authors and sponsors failing to submit studies with negative results, but may also occur after submission. We evaluated whether submitted manuscripts on randomized controlled trials (RCTs) with drugs are more likely to be accepted if they report positive results. METHODS: Manuscripts submitted from January 2010 through April 2012 to one general medical journal (BMJ) and seven specialty journals (Annals of the Rheumatic Diseases, British Journal of Ophthalmology, Gut, Heart, Thorax, Diabetologia, and Journal of Hepatology) were included, if at least one study arm assessed the efficacy or safety of a drug and a statistical test was used to evaluate treatment effects. Publication status was retrospectively retrieved from submission systems or provided by journals. Sponsorship and trial results were extracted from manuscripts and classified according to predefined criteria. Main outcome measure was acceptance for publication. RESULTS: Of 15,972 manuscripts submitted, 472 (3.0%) were drug RCTs, of which 98 (20.8%) were published. Among submitted drug RCTs, 287 (60.8%) had positive and 185 (39.2%) negative results. Of these, 60 (20.9%) and 38 (20.5%), respectively, were published. Manuscripts on non-industry trials (n = 213) reported positive results in 138 (64.8%) manuscripts, compared to 71 (47.7%) on industry-supported trials (n = 149), and 78 (70.9%) on industry-sponsored trials (n = 110). Twenty-seven (12.7%) non-industry trials were published, compared to 27 (18.1%) industry-supported and 44 (40.0%) industry-sponsored trials. After adjustment for other trial characteristics, manuscripts reporting positive results were not more likely to be published (OR, 1.00; 95% CI, 0.61 to 1.66). Submission to specialty journals, sample size, multicentre status, journal impact factor, and corresponding authors from Europe or US were significantly associated with publication. CONCLUSIONS: For the selected journals, there was no tendency to preferably publish manuscripts on drug RCTs that reported positive results, suggesting that publication bias may occur mainly prior to submission. Public Library of Science 2014-08-12 /pmc/articles/PMC4130599/ /pubmed/25118182 http://dx.doi.org/10.1371/journal.pone.0104846 Text en © 2014 van Lent et al http://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
spellingShingle Research Article
van Lent, Marlies
Overbeke, John
Out, Henk Jan
Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals
title Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals
title_full Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals
title_fullStr Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals
title_full_unstemmed Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals
title_short Role of Editorial and Peer Review Processes in Publication Bias: Analysis of Drug Trials Submitted to Eight Medical Journals
title_sort role of editorial and peer review processes in publication bias: analysis of drug trials submitted to eight medical journals
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4130599/
https://www.ncbi.nlm.nih.gov/pubmed/25118182
http://dx.doi.org/10.1371/journal.pone.0104846
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