Non-inferiority clinical trials: importance and applications in health sciences

Detalhes bibliográficos
Autor(a) principal: HONÓRIO,Heitor Marques
Data de Publicação: 2020
Outros Autores: WANG,Linda, RIOS,Daniela
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Brazilian Oral Research
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300200
Resumo: Abstract Non-inferiority randomized clinical trials are indicated when it is intended to prove that an experimental group is not inferior to a control group by more than a margin of non-inferiority. However, this type of study differs from traditional randomized clinical trials (superiority studies) because they have particularities that impact on the formulation of hypothesis to be tested, experimental design (non-inferiority margin determination, adapted sample size calculation, sensitivity of the study and data final analysis) and also on the presentation of data when writing the manuscript. Therefore, this article aims to present and discuss the particularities of non-inferiority clinical studies, since these requirements are fundamental to guarantee the validity of the conclusions of this type of study.
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spelling Non-inferiority clinical trials: importance and applications in health sciencesRandomized Controlled TrialEquivalence TrialStudy CharacteristicsAbstract Non-inferiority randomized clinical trials are indicated when it is intended to prove that an experimental group is not inferior to a control group by more than a margin of non-inferiority. However, this type of study differs from traditional randomized clinical trials (superiority studies) because they have particularities that impact on the formulation of hypothesis to be tested, experimental design (non-inferiority margin determination, adapted sample size calculation, sensitivity of the study and data final analysis) and also on the presentation of data when writing the manuscript. Therefore, this article aims to present and discuss the particularities of non-inferiority clinical studies, since these requirements are fundamental to guarantee the validity of the conclusions of this type of study.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=S1806-83242020000300200Brazilian Oral Research v.34 suppl.2 2020reponame:Brazilian Oral Researchinstname:Sociedade Brasileira de Pesquisa Odontológica (SBPqO)instacron:SBPQO10.1590/1807-3107bor-2020.vol34.0072info:eu-repo/semantics/openAccessHONÓRIO,Heitor MarquesWANG,LindaRIOS,Danielaeng2020-08-05T00:00:00Zoai:scielo:S1806-83242020000300200Revistahttps://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 Non-inferiority clinical trials: importance and applications in health sciences
title Non-inferiority clinical trials: importance and applications in health sciences
spellingShingle Non-inferiority clinical trials: importance and applications in health sciences
HONÓRIO,Heitor Marques
Randomized Controlled Trial
Equivalence Trial
Study Characteristics
title_short Non-inferiority clinical trials: importance and applications in health sciences
title_full Non-inferiority clinical trials: importance and applications in health sciences
title_fullStr Non-inferiority clinical trials: importance and applications in health sciences
title_full_unstemmed Non-inferiority clinical trials: importance and applications in health sciences
title_sort Non-inferiority clinical trials: importance and applications in health sciences
author HONÓRIO,Heitor Marques
author_facet HONÓRIO,Heitor Marques
WANG,Linda
RIOS,Daniela
author_role author
author2 WANG,Linda
RIOS,Daniela
author2_role author
author
dc.contributor.author.fl_str_mv HONÓRIO,Heitor Marques
WANG,Linda
RIOS,Daniela
dc.subject.por.fl_str_mv Randomized Controlled Trial
Equivalence Trial
Study Characteristics
topic Randomized Controlled Trial
Equivalence Trial
Study Characteristics
description Abstract Non-inferiority randomized clinical trials are indicated when it is intended to prove that an experimental group is not inferior to a control group by more than a margin of non-inferiority. However, this type of study differs from traditional randomized clinical trials (superiority studies) because they have particularities that impact on the formulation of hypothesis to be tested, experimental design (non-inferiority margin determination, adapted sample size calculation, sensitivity of the study and data final analysis) and also on the presentation of data when writing the manuscript. Therefore, this article aims to present and discuss the particularities of non-inferiority clinical studies, since these requirements are fundamental to guarantee the validity of the conclusions of this type of study.
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
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status_str publishedVersion
dc.identifier.uri.fl_str_mv http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300200
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S1806-83242020000300200
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/1807-3107bor-2020.vol34.0072
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)
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reponame_str Brazilian Oral Research
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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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