PLACEBO USE IN THE CONTEXT OF INFLAMMATORY BOWEL DISEASE CLINICAL TRIALS
Autor(a) principal: | |
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Data de Publicação: | 2020 |
Outros Autores: | , , |
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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Arquivos de gastroenterologia (Online) |
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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 |
_version_ |
1754193349914394624 |