Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

<h4>Background</h4>Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.<h...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Anette Blümle, Joerg J Meerpohl, Martin Schumacher, Erik von Elm
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2014
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/2f0473023d6544ae9d930b16dfd1be0a
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:2f0473023d6544ae9d930b16dfd1be0a
record_format	dspace
spelling	oai:doaj.org-article:2f0473023d6544ae9d930b16dfd1be0a2021-11-18T08:32:08ZFate of clinical research studies after ethical approval--follow-up of study protocols until publication.1932-620310.1371/journal.pone.0087184https://doaj.org/article/2f0473023d6544ae9d930b16dfd1be0a2014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24586265/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.<h4>Methods</h4>We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.<h4>Results</h4>Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71%) were completed according to protocol, 128 (16%) discontinued and 42 (5%) are still ongoing; for 61 (8%) there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55). Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48%) protocols and in 205 (49%) of the publications. In most published studies (339; 81%) this information corresponded between protocol and publication. Most studies were published in English (367; 88%); some in German (25; 6%) or both languages (27; 6%). The local investigators were listed as (co-)authors in the publications corresponding to 259 (62%) studies.<h4>Conclusion</h4>Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care professionals nor patients nor policy makers can use the results when making decisions.Anette BlümleJoerg J MeerpohlMartin SchumacherErik von ElmPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 2, p e87184 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Anette Blümle Joerg J Meerpohl Martin Schumacher Erik von Elm Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.
description	<h4>Background</h4>Many clinical studies are ultimately not fully published in peer-reviewed journals. Underreporting of clinical research is wasteful and can result in biased estimates of treatment effect or harm, leading to recommendations that are inappropriate or even dangerous.<h4>Methods</h4>We assembled a cohort of clinical studies approved 2000-2002 by the Research Ethics Committee of the University of Freiburg, Germany. Published full articles were searched in electronic databases and investigators contacted. Data on study characteristics were extracted from protocols and corresponding publications. We characterized the cohort, quantified its publication outcome and compared protocols and publications for selected aspects.<h4>Results</h4>Of 917 approved studies, 807 were started and 110 were not, either locally or as a whole. Of the started studies, 576 (71%) were completed according to protocol, 128 (16%) discontinued and 42 (5%) are still ongoing; for 61 (8%) there was no information about their course. We identified 782 full publications corresponding to 419 of the 807 initiated studies; the publication proportion was 52% (95% CI: 0.48-0.55). Study design was not significantly associated with subsequent publication. Multicentre status, international collaboration, large sample size and commercial or non-commercial funding were positively associated with subsequent publication. Commercial funding was mentioned in 203 (48%) protocols and in 205 (49%) of the publications. In most published studies (339; 81%) this information corresponded between protocol and publication. Most studies were published in English (367; 88%); some in German (25; 6%) or both languages (27; 6%). The local investigators were listed as (co-)authors in the publications corresponding to 259 (62%) studies.<h4>Conclusion</h4>Half of the clinical research conducted at a large German university medical centre remains unpublished; future research is built on an incomplete database. Research resources are likely wasted as neither health care professionals nor patients nor policy makers can use the results when making decisions.
format	article
author	Anette Blümle Joerg J Meerpohl Martin Schumacher Erik von Elm
author_facet	Anette Blümle Joerg J Meerpohl Martin Schumacher Erik von Elm
author_sort	Anette Blümle
title	Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.
title_short	Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.
title_full	Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.
title_fullStr	Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.
title_full_unstemmed	Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.
title_sort	fate of clinical research studies after ethical approval--follow-up of study protocols until publication.
publisher	Public Library of Science (PLoS)
publishDate	2014
url	https://doaj.org/article/2f0473023d6544ae9d930b16dfd1be0a
work_keys_str_mv	AT anetteblumle fateofclinicalresearchstudiesafterethicalapprovalfollowupofstudyprotocolsuntilpublication AT joergjmeerpohl fateofclinicalresearchstudiesafterethicalapprovalfollowupofstudyprotocolsuntilpublication AT martinschumacher fateofclinicalresearchstudiesafterethicalapprovalfollowupofstudyprotocolsuntilpublication AT erikvonelm fateofclinicalresearchstudiesafterethicalapprovalfollowupofstudyprotocolsuntilpublication
_version_	1718421674983948288

Fate of clinical research studies after ethical approval--follow-up of study protocols until publication.

Ejemplares similares