Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).

<h4>Objective</h4>To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols.<h4>Methods</h4>We conducted an observational retrospective cohort study to identify the protocol...

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Autores principales:	Xavier Bonfill, Mónica Ballesteros, Ignasi Gich, María Antonia Serrano, Fernando García López, Gerard Urrútia
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2013
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/1d0cdf382b0144b5937a25a874be0128
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spelling	oai:doaj.org-article:1d0cdf382b0144b5937a25a874be01282021-11-18T08:46:44ZDescription of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).1932-620310.1371/journal.pone.0079684https://doaj.org/article/1d0cdf382b0144b5937a25a874be01282013-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24236154/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Objective</h4>To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols.<h4>Methods</h4>We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed.<h4>Results</h4>We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower.<h4>Conclusion</h4>RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on-going initiatives that aim to increase the transparency and quality of future research.Xavier BonfillMónica BallesterosIgnasi GichMaría Antonia SerranoFernando García LópezGerard UrrútiaPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 8, Iss 11, p e79684 (2013)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Xavier Bonfill Mónica Ballesteros Ignasi Gich María Antonia Serrano Fernando García López Gerard Urrútia Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).
description	<h4>Objective</h4>To describe the characteristics of randomized controlled clinical trials (RCT) on cancer drugs conducted in Spain between 1999 and 2003 based on their protocols.<h4>Methods</h4>We conducted an observational retrospective cohort study to identify the protocols of RCTs on cancer drugs authorized by the Agencia Española del Medicamento y Productos Sanitarios (AEMPS) (Spanish Agency for Medicines and Medical Devices) during 1999-2003. A descriptive analysis was completed and the association between variables based on the study setting and sponsorship were assessed.<h4>Results</h4>We identified a total of 303 protocols, which included 176,835 potentially eligible patients. Three-quarter of the studies were internationally-based, 61.7% were phase III, and 76.2% were sponsored by pharmaceutical companies. The most frequently assessed outcomes were response rate (24.7%), overall survival (20.7%), and progression-free survival (14.5%). Of all protocols, 10.6% intended to include more than 1000 patients (mean: 2442, SD: 2724). Compared with their national counterparts, internationally-based studies were significantly larger (p<0.001) and were more likely to implement centralized randomization (p<0.001), blinding of the intervention (p<0.001), and survival as primary outcome (p<0.001). Additionally, most internationally-based studies were sponsored by pharmaceutical companies (p<0.01). In a high percentage of protocols, the available information was not explicit enough to assess the validity of each trial. Compared to other European countries, the proportion of Spanish cancer drugs protocols registered at www.clinicaltrials.gov (7%) was lower.<h4>Conclusion</h4>RCTs on cancer drugs conducted in Spain between 1999 and 2003 were more likely to be promoted by pharmaceutical companies rather than by non-profit national groups. The former were more often part of international studies, which generally had better methodological quality than national ones. There are some worldwide on-going initiatives that aim to increase the transparency and quality of future research.
format	article
author	Xavier Bonfill Mónica Ballesteros Ignasi Gich María Antonia Serrano Fernando García López Gerard Urrútia
author_facet	Xavier Bonfill Mónica Ballesteros Ignasi Gich María Antonia Serrano Fernando García López Gerard Urrútia
author_sort	Xavier Bonfill
title	Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).
title_short	Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).
title_full	Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).
title_fullStr	Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).
title_full_unstemmed	Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).
title_sort	description of the protocols for randomized controlled trials on cancer drugs conducted in spain (1999-2003).
publisher	Public Library of Science (PLoS)
publishDate	2013
url	https://doaj.org/article/1d0cdf382b0144b5937a25a874be0128
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Description of the protocols for randomized controlled trials on cancer drugs conducted in Spain (1999-2003).

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