Recommendations to choose the primary endpoint in cardiovascular clinical trials

Background – A composite endpoint is often used as the primary endpoint to assess the efficacy of a new treatment in randomized clinical trials (RCT). In cardiovascular trials, the often rare event of the relevant primary endpoint (individual or composite), such as cardiovascular death (CV death), M...

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Authors: Gómez Melis, Guadalupe|||0000-0003-4252-4884, Gómez Mateu, Moisés|||0000-0003-4787-6432, Dafni, Urania
Format: report
Publication Date:2013
Country:España
Institution:Universitat Politècnica de Catalunya (UPC)
Repository:UPCommons. Portal del coneixement obert de la UPC
Language:English
OAI Identifier:oai:upcommons.upc.edu:2117/21995
Online Access:https://hdl.handle.net/2117/21995
Access Level:Open access
Keyword:Asymptotic Relative Efficiency
Composite outcome
Logrank test
Cardiovascular
Randomized Clinical Trial
Investigació operativa -- Reports EIO
Assaigs clínics -- Mètodes estadístics
Classificació AMS::90 Operations research, mathematical programming
Àrees temàtiques de la UPC::Matemàtiques i estadística::Investigació operativa
id ES_bc55b0f1476495c4cafbf02e072fbdc9
oai_identifier_str oai:upcommons.upc.edu:2117/21995
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repository_id_str
spelling Recommendations to choose the primary endpoint in cardiovascular clinical trialsGómez Melis, Guadalupe|||0000-0003-4252-4884Gómez Mateu, Moisés|||0000-0003-4787-6432Dafni, UraniaAsymptotic Relative EfficiencyComposite outcomeLogrank testCardiovascularRandomized Clinical TrialInvestigació operativa -- Reports EIOAssaigs clínics -- Mètodes estadísticsClassificació AMS::90 Operations research, mathematical programmingÀrees temàtiques de la UPC::Matemàtiques i estadística::Investigació operativaBackground – A composite endpoint is often used as the primary endpoint to assess the efficacy of a new treatment in randomized clinical trials (RCT). In cardiovascular trials, the often rare event of the relevant primary endpoint (individual or composite), such as cardiovascular death (CV death), Myocardial Infarction (MI), or both, is combined with a more common secondary endpoint, such as target lesion revascularization, with the aim to increase the statistical power of the study. Methods – Gómez and Lagakos developed statistical methodology to be used at the design stage of a RCT for deciding whether to expand a study relevant primary endpoint e1 to e*, the composite of e1 and a secondary endpoint e2. The method uses the asymptotic relative efficiency of the logrank test for comparing treatment groups based on e1 versus the logrank test based on e*. The method is used to assess, in the cardiovascular research area, the characteristics of the candidate individual endpoints that should govern the choice of using a composite endpoint as the primary endpoint in a clinical trial. Results and conclusions – A set of recommendations is provided based on the reported values of the frequencies of observing each candidate endpoint as well as on the magnitude of the effect of treatment as expressed by the hazard ratio, supported by cardiovascular RCTs published in 2008.20132013-01-0120142014-03-11reporthttp://purl.org/coar/resource_type/c_93fcAOhttp://purl.org/coar/version/c_b1a7d7d4d402bcceinfo:eu-repo/semantics/reportapplication/pdfhttps://hdl.handle.net/2117/21995reponame:UPCommons. Portal del coneixement obert de la UPCinstname:Universitat Politècnica de Catalunya (UPC)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivs 3.0 Spainhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/info:eu-repo/semantics/openAccessoai:upcommons.upc.edu:2117/219952026-05-27T15:37:01Z
dc.title.none.fl_str_mv Recommendations to choose the primary endpoint in cardiovascular clinical trials
title Recommendations to choose the primary endpoint in cardiovascular clinical trials
spellingShingle Recommendations to choose the primary endpoint in cardiovascular clinical trials
Gómez Melis, Guadalupe|||0000-0003-4252-4884
Asymptotic Relative Efficiency
Composite outcome
Logrank test
Cardiovascular
Randomized Clinical Trial
Investigació operativa -- Reports EIO
Assaigs clínics -- Mètodes estadístics
Classificació AMS::90 Operations research, mathematical programming
Àrees temàtiques de la UPC::Matemàtiques i estadística::Investigació operativa
title_short Recommendations to choose the primary endpoint in cardiovascular clinical trials
title_full Recommendations to choose the primary endpoint in cardiovascular clinical trials
title_fullStr Recommendations to choose the primary endpoint in cardiovascular clinical trials
title_full_unstemmed Recommendations to choose the primary endpoint in cardiovascular clinical trials
title_sort Recommendations to choose the primary endpoint in cardiovascular clinical trials
dc.creator.none.fl_str_mv Gómez Melis, Guadalupe|||0000-0003-4252-4884
Gómez Mateu, Moisés|||0000-0003-4787-6432
Dafni, Urania
author Gómez Melis, Guadalupe|||0000-0003-4252-4884
author_facet Gómez Melis, Guadalupe|||0000-0003-4252-4884
Gómez Mateu, Moisés|||0000-0003-4787-6432
Dafni, Urania
author_role author
author2 Gómez Mateu, Moisés|||0000-0003-4787-6432
Dafni, Urania
author2_role author
author
dc.subject.none.fl_str_mv Asymptotic Relative Efficiency
Composite outcome
Logrank test
Cardiovascular
Randomized Clinical Trial
Investigació operativa -- Reports EIO
Assaigs clínics -- Mètodes estadístics
Classificació AMS::90 Operations research, mathematical programming
Àrees temàtiques de la UPC::Matemàtiques i estadística::Investigació operativa
topic Asymptotic Relative Efficiency
Composite outcome
Logrank test
Cardiovascular
Randomized Clinical Trial
Investigació operativa -- Reports EIO
Assaigs clínics -- Mètodes estadístics
Classificació AMS::90 Operations research, mathematical programming
Àrees temàtiques de la UPC::Matemàtiques i estadística::Investigació operativa
description Background – A composite endpoint is often used as the primary endpoint to assess the efficacy of a new treatment in randomized clinical trials (RCT). In cardiovascular trials, the often rare event of the relevant primary endpoint (individual or composite), such as cardiovascular death (CV death), Myocardial Infarction (MI), or both, is combined with a more common secondary endpoint, such as target lesion revascularization, with the aim to increase the statistical power of the study. Methods – Gómez and Lagakos developed statistical methodology to be used at the design stage of a RCT for deciding whether to expand a study relevant primary endpoint e1 to e*, the composite of e1 and a secondary endpoint e2. The method uses the asymptotic relative efficiency of the logrank test for comparing treatment groups based on e1 versus the logrank test based on e*. The method is used to assess, in the cardiovascular research area, the characteristics of the candidate individual endpoints that should govern the choice of using a composite endpoint as the primary endpoint in a clinical trial. Results and conclusions – A set of recommendations is provided based on the reported values of the frequencies of observing each candidate endpoint as well as on the magnitude of the effect of treatment as expressed by the hazard ratio, supported by cardiovascular RCTs published in 2008.
publishDate 2013
dc.date.none.fl_str_mv 2013
2013-01-01
2014
2014-03-11
dc.type.none.fl_str_mv report
http://purl.org/coar/resource_type/c_93fc
AO
http://purl.org/coar/version/c_b1a7d7d4d402bcce
dc.type.openaire.fl_str_mv info:eu-repo/semantics/report
format report
dc.identifier.none.fl_str_mv https://hdl.handle.net/2117/21995
url https://hdl.handle.net/2117/21995
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivs 3.0 Spain
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivs 3.0 Spain
http://creativecommons.org/licenses/by-nc-nd/3.0/es/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:UPCommons. Portal del coneixement obert de la UPC
instname:Universitat Politècnica de Catalunya (UPC)
instname_str Universitat Politècnica de Catalunya (UPC)
reponame_str UPCommons. Portal del coneixement obert de la UPC
collection UPCommons. Portal del coneixement obert de la UPC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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