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Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary
BACKGROUND: Clinical research should provide reliable evidence to clinicians, health policy makers, and researchers. The reliability of evidence will be assured once study planning, conducting, and reporting of results are transparent. The present research investigates publication rates, time until...
Autores principales: | , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9022244/ https://www.ncbi.nlm.nih.gov/pubmed/35449017 http://dx.doi.org/10.1186/s13063-022-06268-y |
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author | Sándor-Bajusz, Kinga Amália Kraut, Andrea Baasan, Odgerel Márovics, Gergely Berényi, Károly Lohner, Szimonetta |
author_facet | Sándor-Bajusz, Kinga Amália Kraut, Andrea Baasan, Odgerel Márovics, Gergely Berényi, Károly Lohner, Szimonetta |
author_sort | Sándor-Bajusz, Kinga Amália |
collection | PubMed |
description | BACKGROUND: Clinical research should provide reliable evidence to clinicians, health policy makers, and researchers. The reliability of evidence will be assured once study planning, conducting, and reporting of results are transparent. The present research investigates publication rates, time until publication, and characteristics of clinical trials on medicinal products associated with timely publication of results, measures of scientific impact, authorship, and open access publication. METHODS: Clinical trials authorized in Hungary in 2012 were followed until publication and/or June 2020. Corresponding scientific publications were searched via clinical trial registries, PubMed (MEDLINE), and Google. RESULTS: Overall, 330 clinical trials were authorized in 2012 of which 232 trials were completed for more than 1 year in June 2020. The proportion of industry initiation was high (97%). Time to publication was 21 (22) months [median (IQR)]. Time to publication was significantly shorter when trials involved both European and non-European countries (26 vs 69 months [median]; hazard ratio = 0.38, 95% CI 0.22–0.66, p< 0.001), and were registered in both EU CTR and clinicaltrials.gov (27 vs 88 months; hazard ratio = 0.24, 95% CI 0.11–0.54; p< 0.001) based on survival analyses. A significant amount (24.1%) of unpublished clinical trial results were accessible in a trial register. The majority of available publications were published “open access” (70.93%). A minority of identified publications had a Hungarian author (21.5%). CONCLUSIONS: We encourage academic researchers to plan, register and conduct trials on medicinal products. Registries should be considered as an important source of information of clinical trial results. Publications with domestic co-authors contribute to the research output of a country. Measurable domestic scientific impact of trials on medicinal products needs further improvement. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06268-y. |
format | Online Article Text |
id | pubmed-9022244 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-90222442022-04-22 Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary Sándor-Bajusz, Kinga Amália Kraut, Andrea Baasan, Odgerel Márovics, Gergely Berényi, Károly Lohner, Szimonetta Trials Research BACKGROUND: Clinical research should provide reliable evidence to clinicians, health policy makers, and researchers. The reliability of evidence will be assured once study planning, conducting, and reporting of results are transparent. The present research investigates publication rates, time until publication, and characteristics of clinical trials on medicinal products associated with timely publication of results, measures of scientific impact, authorship, and open access publication. METHODS: Clinical trials authorized in Hungary in 2012 were followed until publication and/or June 2020. Corresponding scientific publications were searched via clinical trial registries, PubMed (MEDLINE), and Google. RESULTS: Overall, 330 clinical trials were authorized in 2012 of which 232 trials were completed for more than 1 year in June 2020. The proportion of industry initiation was high (97%). Time to publication was 21 (22) months [median (IQR)]. Time to publication was significantly shorter when trials involved both European and non-European countries (26 vs 69 months [median]; hazard ratio = 0.38, 95% CI 0.22–0.66, p< 0.001), and were registered in both EU CTR and clinicaltrials.gov (27 vs 88 months; hazard ratio = 0.24, 95% CI 0.11–0.54; p< 0.001) based on survival analyses. A significant amount (24.1%) of unpublished clinical trial results were accessible in a trial register. The majority of available publications were published “open access” (70.93%). A minority of identified publications had a Hungarian author (21.5%). CONCLUSIONS: We encourage academic researchers to plan, register and conduct trials on medicinal products. Registries should be considered as an important source of information of clinical trial results. Publications with domestic co-authors contribute to the research output of a country. Measurable domestic scientific impact of trials on medicinal products needs further improvement. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06268-y. BioMed Central 2022-04-21 /pmc/articles/PMC9022244/ /pubmed/35449017 http://dx.doi.org/10.1186/s13063-022-06268-y Text en © The Author(s) 2022 https://creativecommons.org/licenses/by/4.0/Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) . The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/ (https://creativecommons.org/publicdomain/zero/1.0/) ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. |
spellingShingle | Research Sándor-Bajusz, Kinga Amália Kraut, Andrea Baasan, Odgerel Márovics, Gergely Berényi, Károly Lohner, Szimonetta Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary |
title | Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary |
title_full | Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary |
title_fullStr | Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary |
title_full_unstemmed | Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary |
title_short | Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary |
title_sort | publication of clinical trials on medicinal products: follow-up on trials authorized in hungary |
topic | Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9022244/ https://www.ncbi.nlm.nih.gov/pubmed/35449017 http://dx.doi.org/10.1186/s13063-022-06268-y |
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