Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences

Detalhes bibliográficos
Autor(a) principal: Vinicius,PEDRAZZI
Data de Publicação: 2020
Outros Autores: FIGUEIREDO,Fellipe Augusto Tocchini de, ADAMI,Larisse Eduardo, FURLANETO,Flávia, PALIOTO,Daniela Bazan, MESSORA,Michel Reis
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Oral Research
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300602
Resumo: Abstract Clinical research needs to formulate a question, which must be answered by obeying ethical precepts with well-defined inclusion/exclusion criteria and approval of the study on platforms of ethical appreciation and clinical trial records. In comparing the results or clinically relevant outcomes should be prioritized in the study of techniques, products, inputs, drugs and therapies. However, it is not always possible to use long study drawings, with many participants, and with many costs, then look for study designs with surrogate outcomes, usually a shorter path, with less sample size and considerably lower costs to the research, with shorter intervention time. Considering these outcomes as major challenges in clinical research, the premise of this work was to examine in relevant research platforms, studies on the feasibility of using surrogate endpoints for clinically relevant parameters in dentistry, with a critical evaluation of the advantages, disadvantages, and need for validation of substitute parameters for clinical studies. After a critical analysis of the results, it could be concluded that surrogate endpoints may have an important role in the initial process of developing new drugs, faster, with less sampling, and lower risk of side effects for the patient. Careful use of the surrogate endpoints is advised because, even if validated, they can provide ambiguous evidence and not be extrapolated to other populations, and may lead to bias due to the individual interpretation of each researcher. The use of unplanned surrogate outcomes that arise during the study requires a lot of caution.
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spelling Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidencesDentistryClinical TrialsEthicsBiomarkersAbstract Clinical research needs to formulate a question, which must be answered by obeying ethical precepts with well-defined inclusion/exclusion criteria and approval of the study on platforms of ethical appreciation and clinical trial records. In comparing the results or clinically relevant outcomes should be prioritized in the study of techniques, products, inputs, drugs and therapies. However, it is not always possible to use long study drawings, with many participants, and with many costs, then look for study designs with surrogate outcomes, usually a shorter path, with less sample size and considerably lower costs to the research, with shorter intervention time. Considering these outcomes as major challenges in clinical research, the premise of this work was to examine in relevant research platforms, studies on the feasibility of using surrogate endpoints for clinically relevant parameters in dentistry, with a critical evaluation of the advantages, disadvantages, and need for validation of substitute parameters for clinical studies. After a critical analysis of the results, it could be concluded that surrogate endpoints may have an important role in the initial process of developing new drugs, faster, with less sampling, and lower risk of side effects for the patient. Careful use of the surrogate endpoints is advised because, even if validated, they can provide ambiguous evidence and not be extrapolated to other populations, and may lead to bias due to the individual interpretation of each researcher. The use of unplanned surrogate outcomes that arise during the study requires a lot of caution.Sociedade Brasileira de Pesquisa Odontológica - SBPqO2020-01-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300602Brazilian Oral Research v.34 suppl.2 2020reponame:Brazilian Oral Researchinstname:Sociedade Brasileira de Pesquisa Odontológica (SBPqO)instacron:SBPQO10.1590/1807-3107bor-2020.vol34.0074info:eu-repo/semantics/openAccessVinicius,PEDRAZZIFIGUEIREDO,Fellipe Augusto Tocchini deADAMI,Larisse EduardoFURLANETO,FláviaPALIOTO,Daniela BazanMESSORA,Michel Reiseng2020-08-05T00:00:00Zoai:scielo:S1806-83242020000300602Revistahttps://www.scielo.br/j/bor/https://old.scielo.br/oai/scielo-oai.phppob@edu.usp.br||bor@sbpqo.org.br1807-31071806-8324opendoar:2020-08-05T00:00Brazilian Oral Research - Sociedade Brasileira de Pesquisa Odontológica (SBPqO)false
dc.title.none.fl_str_mv Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
title Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
spellingShingle Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
Vinicius,PEDRAZZI
Dentistry
Clinical Trials
Ethics
Biomarkers
title_short Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
title_full Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
title_fullStr Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
title_full_unstemmed Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
title_sort Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
author Vinicius,PEDRAZZI
author_facet Vinicius,PEDRAZZI
FIGUEIREDO,Fellipe Augusto Tocchini de
ADAMI,Larisse Eduardo
FURLANETO,Flávia
PALIOTO,Daniela Bazan
MESSORA,Michel Reis
author_role author
author2 FIGUEIREDO,Fellipe Augusto Tocchini de
ADAMI,Larisse Eduardo
FURLANETO,Flávia
PALIOTO,Daniela Bazan
MESSORA,Michel Reis
author2_role author
author
author
author
author
dc.contributor.author.fl_str_mv Vinicius,PEDRAZZI
FIGUEIREDO,Fellipe Augusto Tocchini de
ADAMI,Larisse Eduardo
FURLANETO,Flávia
PALIOTO,Daniela Bazan
MESSORA,Michel Reis
dc.subject.por.fl_str_mv Dentistry
Clinical Trials
Ethics
Biomarkers
topic Dentistry
Clinical Trials
Ethics
Biomarkers
description Abstract Clinical research needs to formulate a question, which must be answered by obeying ethical precepts with well-defined inclusion/exclusion criteria and approval of the study on platforms of ethical appreciation and clinical trial records. In comparing the results or clinically relevant outcomes should be prioritized in the study of techniques, products, inputs, drugs and therapies. However, it is not always possible to use long study drawings, with many participants, and with many costs, then look for study designs with surrogate outcomes, usually a shorter path, with less sample size and considerably lower costs to the research, with shorter intervention time. Considering these outcomes as major challenges in clinical research, the premise of this work was to examine in relevant research platforms, studies on the feasibility of using surrogate endpoints for clinically relevant parameters in dentistry, with a critical evaluation of the advantages, disadvantages, and need for validation of substitute parameters for clinical studies. After a critical analysis of the results, it could be concluded that surrogate endpoints may have an important role in the initial process of developing new drugs, faster, with less sampling, and lower risk of side effects for the patient. Careful use of the surrogate endpoints is advised because, even if validated, they can provide ambiguous evidence and not be extrapolated to other populations, and may lead to bias due to the individual interpretation of each researcher. The use of unplanned surrogate outcomes that arise during the study requires a lot of caution.
publishDate 2020
dc.date.none.fl_str_mv 2020-01-01
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300602
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dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/1807-3107bor-2020.vol34.0074
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv text/html
dc.publisher.none.fl_str_mv Sociedade Brasileira de Pesquisa Odontológica - SBPqO
publisher.none.fl_str_mv Sociedade Brasileira de Pesquisa Odontológica - SBPqO
dc.source.none.fl_str_mv Brazilian Oral Research v.34 suppl.2 2020
reponame:Brazilian Oral Research
instname:Sociedade Brasileira de Pesquisa Odontológica (SBPqO)
instacron:SBPQO
instname_str Sociedade Brasileira de Pesquisa Odontológica (SBPqO)
instacron_str SBPQO
institution SBPQO
reponame_str Brazilian Oral Research
collection Brazilian Oral Research
repository.name.fl_str_mv Brazilian Oral Research - Sociedade Brasileira de Pesquisa Odontológica (SBPqO)
repository.mail.fl_str_mv pob@edu.usp.br||bor@sbpqo.org.br
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