Surrogate endpoints: when to use and when not to use? A critical appraisal of current evidences
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , , , |
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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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 |
url |
http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300602 |
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 |
_version_ |
1750318327508500480 |