The quality of registration of clinical trials.

<h4>Background</h4>Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However,...

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Autores principales:	Roderik F Viergever, Davina Ghersi
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2011
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/8d741400fc9345a390beda7576e1f015
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spelling	oai:doaj.org-article:8d741400fc9345a390beda7576e1f0152021-11-18T06:58:19ZThe quality of registration of clinical trials.1932-620310.1371/journal.pone.0014701https://doaj.org/article/8d741400fc9345a390beda7576e1f0152011-02-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/21383991/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials.<h4>Methods and findings</h4>A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame.<h4>Conclusions</h4>Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records.Roderik F ViergeverDavina GhersiPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 6, Iss 2, p e14701 (2011)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Roderik F Viergever Davina Ghersi The quality of registration of clinical trials.
description	<h4>Background</h4>Lack of transparency in clinical trial conduct, publication bias and selective reporting bias are still important problems in medical research. Through clinical trials registration, it should be possible to take steps towards resolving some of these problems. However, previous evaluations of registered records of clinical trials have shown that registered information is often incomplete and non-meaningful. If these studies are accurate, this negates the possible benefits of registration of clinical trials.<h4>Methods and findings</h4>A 5% sample of records of clinical trials that were registered between 17 June 2008 and 17 June 2009 was taken from the International Clinical Trials Registry Platform (ICTRP) database and assessed for the presence of contact information, the presence of intervention specifics in drug trials and the quality of primary and secondary outcome reporting. 731 records were included. More than half of the records were registered after recruitment of the first participant. The name of a contact person was available in 94.4% of records from non-industry funded trials and 53.7% of records from industry funded trials. Either an email address or a phone number was present in 76.5% of non-industry funded trial records and in 56.5% of industry funded trial records. Although a drug name or company serial number was almost always provided, other drug intervention specifics were often omitted from registration. Of 3643 reported outcomes, 34.9% were specific measures with a meaningful time frame.<h4>Conclusions</h4>Clinical trials registration has the potential to contribute substantially to improving clinical trial transparency and reducing publication bias and selective reporting. These potential benefits are currently undermined by deficiencies in the provision of information in key areas of registered records.
format	article
author	Roderik F Viergever Davina Ghersi
author_facet	Roderik F Viergever Davina Ghersi
author_sort	Roderik F Viergever
title	The quality of registration of clinical trials.
title_short	The quality of registration of clinical trials.
title_full	The quality of registration of clinical trials.
title_fullStr	The quality of registration of clinical trials.
title_full_unstemmed	The quality of registration of clinical trials.
title_sort	quality of registration of clinical trials.
publisher	Public Library of Science (PLoS)
publishDate	2011
url	https://doaj.org/article/8d741400fc9345a390beda7576e1f015
work_keys_str_mv	AT roderikfviergever thequalityofregistrationofclinicaltrials AT davinaghersi thequalityofregistrationofclinicaltrials AT roderikfviergever qualityofregistrationofclinicaltrials AT davinaghersi qualityofregistrationofclinicaltrials
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The quality of registration of clinical trials.

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