Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil
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Data de Publicação: | 2015 |
Outros Autores: | |
Tipo de documento: | Artigo |
Idioma: | por eng |
Título da fonte: | RECIIS (Online) |
Texto Completo: | https://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/881 |
Resumo: | The purpose of this text is to present the discussions about the registration of clinical trials which are currently underway worldwide and discuss the possibilities for international insertion available to Brazil. Clinical trials are one of the most valuable sources of evidence about the effectiveness and safety of health interventions. However, this evidence is disseminated mainly through scientific journals and is therefore subject to the so-called publication bias: articles which present statistically significant results, obtained through large-scale, good quality studies and which are favorable for the industry, have a higher chance of being published. Registering clinical trial protocols in public databases, from their outset, has been proposed as an alternative solution to minimize this problem. A register of clinical trials has been defended for many other reasons – ethical, health, scientific and economic. However, there is no consensus on the principles which should govern these registers or how to operationalize them, due to the divergent interests of researchers, the pharmaceutical industry, government and society. |
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Registration of clinical trials: the international discussion and the possible positions to be taken by BrazilRegistro de ensaios clínicos: a discussão internacional e os posicionamentos possíveis para o BrasilClinical researchclinical trialshealth interventionsregistrationdatabasesPesquisa clínicaensaios clínicosintervenções em saúderegistrobases de dadosThe purpose of this text is to present the discussions about the registration of clinical trials which are currently underway worldwide and discuss the possibilities for international insertion available to Brazil. Clinical trials are one of the most valuable sources of evidence about the effectiveness and safety of health interventions. However, this evidence is disseminated mainly through scientific journals and is therefore subject to the so-called publication bias: articles which present statistically significant results, obtained through large-scale, good quality studies and which are favorable for the industry, have a higher chance of being published. Registering clinical trial protocols in public databases, from their outset, has been proposed as an alternative solution to minimize this problem. A register of clinical trials has been defended for many other reasons – ethical, health, scientific and economic. However, there is no consensus on the principles which should govern these registers or how to operationalize them, due to the divergent interests of researchers, the pharmaceutical industry, government and society.O objetivo deste texto é apresentar as discussões relativas ao registro de ensaios clínicos em pauta no mundo atualmente e discutir as perspectivas de inserção internacional abertas para o Brasil. Os ensaios clínicos são uma das mais valiosas fontes de evidências sobre a eficácia e a segurança de intervenções em saúde. Estas evidências, entretanto, são divulgadas basicamente através de revistas científicas e sujeitas ao chamado viés de publicação: artigos que apresentem resultados estatisticamente significativos, obtidos a partir de grandes estudos, de boa qualidade, favoráveis à industria, têm maior probabilidade de serem publicados. O registro dos protocolos dos ensaios clínicos em bases de dados públicas, quando do seu início, tem sido apresentado como alternativa de minimizar o problema. O registro de ensaios clínicos tem sido defendido por inúmeras outras razões – éticas, sanitárias, científicas e econômicas. Entretanto, nem os princípios que devem reger estes registros nem sua operacionalização são consensuais, em função dos interesses divergentes de pesquisadores, indústria farmacêutica, governo e sociedade.Instituto de Comunicação e Informação Científica e Tecnológica em Saúde (Icict/Fiocruz)2015-03-30info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionAvaliado pelos paresapplication/pdfapplication/pdfhttps://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/88110.29397/reciis.v1i1.881Revista Eletrônica de Comunicação, Informação & Inovação em Saúde; Vol. 1 No. 1 (2007)Revista Eletrônica de Comunicação, Informação e Inovação em Saúde; Vol. 1 Núm. 1 (2007)Revue de la Communication, de l'Information et de l'Innovation en santé; Vol. 1 No 1 (2007)Revista Eletrônica de Comunicação, Informação & Inovação em Saúde; v. 1 n. 1 (2007)1981-6278reponame:RECIIS (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/881/1525https://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/881/pdf_14Carvalheiro, José da RochaQuental, Cristianeinfo:eu-repo/semantics/openAccess2022-08-11T14:24:55Zoai:www.reciis.icict.fiocruz.br:article/881Revistahttps://www.reciis.icict.fiocruz.br/index.php/reciishttps://www.reciis.icict.fiocruz.br/index.php/reciis/oaireciis@icict.fiocruz.br1981-62781981-6278opendoar:2022-08-11T14:24:55RECIIS (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil Registro de ensaios clínicos: a discussão internacional e os posicionamentos possíveis para o Brasil |
title |
Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil |
spellingShingle |
Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil Carvalheiro, José da Rocha Clinical research clinical trials health interventions registration databases Pesquisa clínica ensaios clínicos intervenções em saúde registro bases de dados |
title_short |
Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil |
title_full |
Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil |
title_fullStr |
Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil |
title_full_unstemmed |
Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil |
title_sort |
Registration of clinical trials: the international discussion and the possible positions to be taken by Brazil |
author |
Carvalheiro, José da Rocha |
author_facet |
Carvalheiro, José da Rocha Quental, Cristiane |
author_role |
author |
author2 |
Quental, Cristiane |
author2_role |
author |
dc.contributor.author.fl_str_mv |
Carvalheiro, José da Rocha Quental, Cristiane |
dc.subject.por.fl_str_mv |
Clinical research clinical trials health interventions registration databases Pesquisa clínica ensaios clínicos intervenções em saúde registro bases de dados |
topic |
Clinical research clinical trials health interventions registration databases Pesquisa clínica ensaios clínicos intervenções em saúde registro bases de dados |
description |
The purpose of this text is to present the discussions about the registration of clinical trials which are currently underway worldwide and discuss the possibilities for international insertion available to Brazil. Clinical trials are one of the most valuable sources of evidence about the effectiveness and safety of health interventions. However, this evidence is disseminated mainly through scientific journals and is therefore subject to the so-called publication bias: articles which present statistically significant results, obtained through large-scale, good quality studies and which are favorable for the industry, have a higher chance of being published. Registering clinical trial protocols in public databases, from their outset, has been proposed as an alternative solution to minimize this problem. A register of clinical trials has been defended for many other reasons – ethical, health, scientific and economic. However, there is no consensus on the principles which should govern these registers or how to operationalize them, due to the divergent interests of researchers, the pharmaceutical industry, government and society. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-03-30 |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Avaliado pelos pares |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
https://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/881 10.29397/reciis.v1i1.881 |
url |
https://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/881 |
identifier_str_mv |
10.29397/reciis.v1i1.881 |
dc.language.iso.fl_str_mv |
por eng |
language |
por eng |
dc.relation.none.fl_str_mv |
https://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/881/1525 https://www.reciis.icict.fiocruz.br/index.php/reciis/article/view/881/pdf_14 |
dc.rights.driver.fl_str_mv |
info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
dc.format.none.fl_str_mv |
application/pdf application/pdf |
dc.publisher.none.fl_str_mv |
Instituto de Comunicação e Informação Científica e Tecnológica em Saúde (Icict/Fiocruz) |
publisher.none.fl_str_mv |
Instituto de Comunicação e Informação Científica e Tecnológica em Saúde (Icict/Fiocruz) |
dc.source.none.fl_str_mv |
Revista Eletrônica de Comunicação, Informação & Inovação em Saúde; Vol. 1 No. 1 (2007) Revista Eletrônica de Comunicação, Informação e Inovação em Saúde; Vol. 1 Núm. 1 (2007) Revue de la Communication, de l'Information et de l'Innovation en santé; Vol. 1 No 1 (2007) Revista Eletrônica de Comunicação, Informação & Inovação em Saúde; v. 1 n. 1 (2007) 1981-6278 reponame:RECIIS (Online) instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
instname_str |
Fundação Oswaldo Cruz (FIOCRUZ) |
instacron_str |
FIOCRUZ |
institution |
FIOCRUZ |
reponame_str |
RECIIS (Online) |
collection |
RECIIS (Online) |
repository.name.fl_str_mv |
RECIIS (Online) - Fundação Oswaldo Cruz (FIOCRUZ) |
repository.mail.fl_str_mv |
reciis@icict.fiocruz.br |
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