Publication of clinical trials on medicinal products: follow-up on trials authorized in Hungary.
Authorship
Evidence-based medicine
Publication rates
Research impact
Time to publication
Trial registration
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
21 Apr 2022
21 Apr 2022
Historique:
received:
19
04
2021
accepted:
02
04
2022
entrez:
22
4
2022
pubmed:
23
4
2022
medline:
26
4
2022
Statut:
epublish
Résumé
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. 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. 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 A significant amount (24.1%) of unpublished clinical trial results were accessible in a trial register.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%). 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.
Sections du résumé
BACKGROUND
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
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
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
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.
Identifiants
pubmed: 35449017
doi: 10.1186/s13063-022-06268-y
pii: 10.1186/s13063-022-06268-y
pmc: PMC9022244
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
330Subventions
Organisme : Magyar Tudományos Akadémia
ID : BO/00498/17/5
Informations de copyright
© 2022. The Author(s).
Références
Syst Rev. 2012 Nov 29;1:60
pubmed: 23194585
BMJ. 2018 Sep 12;362:k3218
pubmed: 30209058
Lancet Psychiatry. 2018 Nov;5(11):855
pubmed: 30401438
Br J Dermatol. 2017 Jun;176(6):1669-1671
pubmed: 28303566
BMJ Glob Health. 2019 Oct 18;4(5):e001855
pubmed: 31750001
PLoS Med. 2017 Jun 5;14(6):e1002315
pubmed: 28582414
Am J Med Sci. 2020 Nov;360(5):511-516
pubmed: 31955814
PLoS Med. 2016 Jun 21;13(6):e1002049
pubmed: 27328301
Int J Epidemiol. 2016 Dec 1;45(6):2174-2183
pubmed: 28199646
BMJ Evid Based Med. 2019 Apr;24(2):53-54
pubmed: 30523135
J Neurooncol. 2018 Aug;139(1):195-203
pubmed: 29869023
Am Heart J. 2015 Apr;169(4):457-63.e6
pubmed: 25819851
Ann Rheum Dis. 2014 Oct;73(10):1755-60
pubmed: 25114058
Cochrane Database Syst Rev. 2013 Apr 30;(4):ED000057
pubmed: 23728702
Pediatr Crit Care Med. 2020 Dec;21(12):1035-1041
pubmed: 32590828
BMJ Open. 2019 May 14;9(5):e023394
pubmed: 31092640
Perspect Clin Res. 2020 Jan-Mar;11(1):13-17
pubmed: 32154144
Contemp Clin Trials Commun. 2020 May 27;18:100579
pubmed: 32510004
PLoS Med. 2018 Sep 4;15(9):e1002663
pubmed: 30178782
EMBO Rep. 2014 Dec;15(12):1228-32
pubmed: 25389037
Acta Anaesthesiol Scand. 2011 Oct;55(9):1037-43
pubmed: 21689076