The quality of registration of clinical trials: still a problem.

<h4>Introduction</h4>The benefits of clinical trials registration include improved transparency on clinical trials for healthcare workers and patients, increased accountability of trialists, the potential to address publication bias and selective reporting, and possibilities for research...

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Autores principales:	Roderik F Viergever, Ghassan Karam, Andreas Reis, Davina Ghersi
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2014
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/20f2c11b4f7d4feeab2519b4b50f42e3
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spelling	oai:doaj.org-article:20f2c11b4f7d4feeab2519b4b50f42e32021-11-18T08:38:02ZThe quality of registration of clinical trials: still a problem.1932-620310.1371/journal.pone.0084727https://doaj.org/article/20f2c11b4f7d4feeab2519b4b50f42e32014-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24427293/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Introduction</h4>The benefits of clinical trials registration include improved transparency on clinical trials for healthcare workers and patients, increased accountability of trialists, the potential to address publication bias and selective reporting, and possibilities for research collaboration and prioritization. However, poor quality of information in registered records of trials has been found to undermine these benefits in the past. Trialists' increasing experience with trial registration and recent developments in registration systems may have positively affected data quality. This study was conducted to investigate whether the quality of registration has improved.<h4>Methods</h4>We repeated a study from 2009, using the same methods and the same research team. A random sample of 400 records of clinical trials that were registered between 01/01/2012 and 01/01/2013 was taken from the International Clinical Trials Registry Platform (ICTRP) and assessed for the quality of information on 1) contact details, 2) interventions and 3) primary outcomes. Results were compared to the equivalent assessments from our previous study.<h4>Results</h4>There was a small and not statistically significant increase from 81.0% to 85.5% in the percentage of records that provided a name of a contact person. There was a significant increase from 68.7% to 74.9% in the number of records that provided either an email address or a telephone number. There was a significant increase from 44.2% to 51.9% in the number of intervention arms that were complete in registering intervention specifics. There was a significant increase from 38.2% to 57.6% in the number of primary outcomes that were specific measures with a meaningful timeframe. Approximately half of all trials continued to be retrospectively registered.<h4>Discussion</h4>There have been small but significant improvements in the quality of registration since 2009. Important problems with quality remain and continue to constitute an impediment to the meaningful utilization of registered trial information.Roderik F ViergeverGhassan KaramAndreas ReisDavina GhersiPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 9, Iss 1, p e84727 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Roderik F Viergever Ghassan Karam Andreas Reis Davina Ghersi The quality of registration of clinical trials: still a problem.
description	<h4>Introduction</h4>The benefits of clinical trials registration include improved transparency on clinical trials for healthcare workers and patients, increased accountability of trialists, the potential to address publication bias and selective reporting, and possibilities for research collaboration and prioritization. However, poor quality of information in registered records of trials has been found to undermine these benefits in the past. Trialists' increasing experience with trial registration and recent developments in registration systems may have positively affected data quality. This study was conducted to investigate whether the quality of registration has improved.<h4>Methods</h4>We repeated a study from 2009, using the same methods and the same research team. A random sample of 400 records of clinical trials that were registered between 01/01/2012 and 01/01/2013 was taken from the International Clinical Trials Registry Platform (ICTRP) and assessed for the quality of information on 1) contact details, 2) interventions and 3) primary outcomes. Results were compared to the equivalent assessments from our previous study.<h4>Results</h4>There was a small and not statistically significant increase from 81.0% to 85.5% in the percentage of records that provided a name of a contact person. There was a significant increase from 68.7% to 74.9% in the number of records that provided either an email address or a telephone number. There was a significant increase from 44.2% to 51.9% in the number of intervention arms that were complete in registering intervention specifics. There was a significant increase from 38.2% to 57.6% in the number of primary outcomes that were specific measures with a meaningful timeframe. Approximately half of all trials continued to be retrospectively registered.<h4>Discussion</h4>There have been small but significant improvements in the quality of registration since 2009. Important problems with quality remain and continue to constitute an impediment to the meaningful utilization of registered trial information.
format	article
author	Roderik F Viergever Ghassan Karam Andreas Reis Davina Ghersi
author_facet	Roderik F Viergever Ghassan Karam Andreas Reis Davina Ghersi
author_sort	Roderik F Viergever
title	The quality of registration of clinical trials: still a problem.
title_short	The quality of registration of clinical trials: still a problem.
title_full	The quality of registration of clinical trials: still a problem.
title_fullStr	The quality of registration of clinical trials: still a problem.
title_full_unstemmed	The quality of registration of clinical trials: still a problem.
title_sort	quality of registration of clinical trials: still a problem.
publisher	Public Library of Science (PLoS)
publishDate	2014
url	https://doaj.org/article/20f2c11b4f7d4feeab2519b4b50f42e3
work_keys_str_mv	AT roderikfviergever thequalityofregistrationofclinicaltrialsstillaproblem AT ghassankaram thequalityofregistrationofclinicaltrialsstillaproblem AT andreasreis thequalityofregistrationofclinicaltrialsstillaproblem AT davinaghersi thequalityofregistrationofclinicaltrialsstillaproblem AT roderikfviergever qualityofregistrationofclinicaltrialsstillaproblem AT ghassankaram qualityofregistrationofclinicaltrialsstillaproblem AT andreasreis qualityofregistrationofclinicaltrialsstillaproblem AT davinaghersi qualityofregistrationofclinicaltrialsstillaproblem
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The quality of registration of clinical trials: still a problem.

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