PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS

Detalhes bibliográficos
Autor(a) principal: LASA,Juan Sebastian
Data de Publicação: 2020
Outros Autores: ZUBIAURRE,Ignacio, RAUSCH,Astrid, OLIVERA,Pablo
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Arquivos de gastroenterologia (Online)
Texto Completo: http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-28032020000100087
Resumo: ABSTRACT Inflammatory bowel disease comprises two distinct conditions - Crohn’s disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.
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spelling PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALSPlacebosInflammatory bowel diseasesClinical trialABSTRACT Inflammatory bowel disease comprises two distinct conditions - Crohn’s disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia e Outras Especialidades - IBEPEGE. 2020-02-01info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersiontext/htmlhttp://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-28032020000100087Arquivos de Gastroenterologia v.57 n.1 2020reponame:Arquivos de gastroenterologia (Online)instname:Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologiainstacron:IBEPEGE10.1590/s0004-2803.202000000-15info:eu-repo/semantics/openAccessLASA,Juan SebastianZUBIAURRE,IgnacioRAUSCH,AstridOLIVERA,Pabloeng2020-04-07T00:00:00Zoai:scielo:S0004-28032020000100087Revistahttp://www.scielo.br/aghttps://old.scielo.br/oai/scielo-oai.php||secretariaarqgastr@hospitaligesp.com.br1678-42190004-2803opendoar:2020-04-07T00:00Arquivos de gastroenterologia (Online) - Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologiafalse
dc.title.none.fl_str_mv PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
title PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
spellingShingle PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
LASA,Juan Sebastian
Placebos
Inflammatory bowel diseases
Clinical trial
title_short PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
title_full PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
title_fullStr PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
title_full_unstemmed PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
title_sort PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
author LASA,Juan Sebastian
author_facet LASA,Juan Sebastian
ZUBIAURRE,Ignacio
RAUSCH,Astrid
OLIVERA,Pablo
author_role author
author2 ZUBIAURRE,Ignacio
RAUSCH,Astrid
OLIVERA,Pablo
author2_role author
author
author
dc.contributor.author.fl_str_mv LASA,Juan Sebastian
ZUBIAURRE,Ignacio
RAUSCH,Astrid
OLIVERA,Pablo
dc.subject.por.fl_str_mv Placebos
Inflammatory bowel diseases
Clinical trial
topic Placebos
Inflammatory bowel diseases
Clinical trial
description ABSTRACT Inflammatory bowel disease comprises two distinct conditions - Crohn’s disease and ulcerative colitis - which can be treated with immunomodulators. A non-neglectable proportion of these patients will need biologic therapy, and many patients under biologic treatment will experience either primary or secondary failure. As a consequence, clinical trials evaluating new therapeutic alternatives are being developed. These trials share common features, such as being controlled with placebo. Placebo use in clinical trials is a matter of intense debate. Those who support placebo use highlight the methodologic advantages placebo-controlled trials have. Those against placebo use argue that it would be against ethical principles in clinical research to expose a patient to placebo when a valid therapeutic alternative exists. In this review, we summarize the existing arguments for and against the use of placebo in the context of inflammatory bowel disease research. We finally suggest that it is very likely that in the near future inflammatory bowel disease trials will no longer be controlled with a placebo arm, but instead they will be non-inferiority trials with an active comparator.
publishDate 2020
dc.date.none.fl_str_mv 2020-02-01
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=S0004-28032020000100087
url http://old.scielo.br/scielo.php?script=sci_arttext&pid=S0004-28032020000100087
dc.language.iso.fl_str_mv eng
language eng
dc.relation.none.fl_str_mv 10.1590/s0004-2803.202000000-15
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 Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia e Outras Especialidades - IBEPEGE.
publisher.none.fl_str_mv Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia e Outras Especialidades - IBEPEGE.
dc.source.none.fl_str_mv Arquivos de Gastroenterologia v.57 n.1 2020
reponame:Arquivos de gastroenterologia (Online)
instname:Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia
instacron:IBEPEGE
instname_str Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia
instacron_str IBEPEGE
institution IBEPEGE
reponame_str Arquivos de gastroenterologia (Online)
collection Arquivos de gastroenterologia (Online)
repository.name.fl_str_mv Arquivos de gastroenterologia (Online) - Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia
repository.mail.fl_str_mv ||secretariaarqgastr@hospitaligesp.com.br
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