Clinical research monitoring : scenarios and challenges
Autor(a) principal: | |
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Data de Publicação: | 2013 |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Institucional da UnB |
Texto Completo: | http://repositorio.unb.br/handle/10482/28688 https://dx.doi.org/10.1590/0037-868217342013 |
Resumo: | Clinical research is essential for the development of new drugs, diagnostic tests and new devices. Clinical monitoring is implemented to improve the quality of research and attain high ethical and scientific standards. This review discusses the role of clinical monitors, taking into account the variety of scenarios in which medical research is developed, and highlights the challenges faced by research teams to ensure that patients rights are respected and that the social role of scientific research is preserved. Specific emphasis is given to the ethical dilemmas related to the multiple roles which clinical monitors play in the research framework, mainly those involving the delicate equilibrium between the loyalty to the sponsor and to the research subjects. The essential role of clinical monitoring for research developed in poor healthcare scenarios is highlighted as an approach to get the local infrastructure strengthening needed to achieve an adequate level of good clinical practices. |
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Romero, Gustavo Adolfo Sierra2017-12-07T05:02:24Z2017-12-07T05:02:24Z2013-02ROMERO, Gustavo Adolfo Sierra. Clinical research monitoring: scenarios and challenges. Revista da Sociedade Brasileira de Medicina Tropical, Uberaba, v. 46, n. 1, p. 03-06, jan./fev. 2013. DOI: http://dx.doi.org/10.1590/0037-868217342013. Disponível em: https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822013000100003&lng=en&tlng=en. Acesso em: 10 set. 2020.http://repositorio.unb.br/handle/10482/28688https://dx.doi.org/10.1590/0037-868217342013Sociedade Brasileira de Medicina Tropical - SBMTRevista da Sociedade Brasileira de Medicina Tropical - (CC BY-NC) - This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. Fonte: https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822013000100003&lng=en&tlng=en. Acesso em: 10 set. 2020.info:eu-repo/semantics/openAccessClinical research monitoring : scenarios and challengesinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleMedicina - pesquisaMonitoramento clínicoEnsaio clínicoÉticaClinical research is essential for the development of new drugs, diagnostic tests and new devices. Clinical monitoring is implemented to improve the quality of research and attain high ethical and scientific standards. This review discusses the role of clinical monitors, taking into account the variety of scenarios in which medical research is developed, and highlights the challenges faced by research teams to ensure that patients rights are respected and that the social role of scientific research is preserved. Specific emphasis is given to the ethical dilemmas related to the multiple roles which clinical monitors play in the research framework, mainly those involving the delicate equilibrium between the loyalty to the sponsor and to the research subjects. The essential role of clinical monitoring for research developed in poor healthcare scenarios is highlighted as an approach to get the local infrastructure strengthening needed to achieve an adequate level of good clinical practices.Faculdade de Medicina (FMD)engreponame:Repositório Institucional da UnBinstname:Universidade de Brasília (UnB)instacron:UNBORIGINALARTIGO_ClinicalResearchMonitoring.pdfARTIGO_ClinicalResearchMonitoring.pdfapplication/pdf292778http://repositorio2.unb.br/jspui/bitstream/10482/28688/2/ARTIGO_ClinicalResearchMonitoring.pdfe5509d5a2259956605cd3b047e48f7eeMD52open access10482/286882023-08-22 15:59:46.735open accessoai:repositorio2.unb.br:10482/28688Biblioteca Digital de Teses e DissertaçõesPUBhttps://repositorio.unb.br/oai/requestopendoar:2023-08-22T18:59:46Repositório Institucional da UnB - Universidade de Brasília (UnB)false |
dc.title.pt_BR.fl_str_mv |
Clinical research monitoring : scenarios and challenges |
title |
Clinical research monitoring : scenarios and challenges |
spellingShingle |
Clinical research monitoring : scenarios and challenges Romero, Gustavo Adolfo Sierra Medicina - pesquisa Monitoramento clínico Ensaio clínico Ética |
title_short |
Clinical research monitoring : scenarios and challenges |
title_full |
Clinical research monitoring : scenarios and challenges |
title_fullStr |
Clinical research monitoring : scenarios and challenges |
title_full_unstemmed |
Clinical research monitoring : scenarios and challenges |
title_sort |
Clinical research monitoring : scenarios and challenges |
author |
Romero, Gustavo Adolfo Sierra |
author_facet |
Romero, Gustavo Adolfo Sierra |
author_role |
author |
dc.contributor.author.fl_str_mv |
Romero, Gustavo Adolfo Sierra |
dc.subject.keyword.pt_BR.fl_str_mv |
Medicina - pesquisa Monitoramento clínico Ensaio clínico Ética |
topic |
Medicina - pesquisa Monitoramento clínico Ensaio clínico Ética |
description |
Clinical research is essential for the development of new drugs, diagnostic tests and new devices. Clinical monitoring is implemented to improve the quality of research and attain high ethical and scientific standards. This review discusses the role of clinical monitors, taking into account the variety of scenarios in which medical research is developed, and highlights the challenges faced by research teams to ensure that patients rights are respected and that the social role of scientific research is preserved. Specific emphasis is given to the ethical dilemmas related to the multiple roles which clinical monitors play in the research framework, mainly those involving the delicate equilibrium between the loyalty to the sponsor and to the research subjects. The essential role of clinical monitoring for research developed in poor healthcare scenarios is highlighted as an approach to get the local infrastructure strengthening needed to achieve an adequate level of good clinical practices. |
publishDate |
2013 |
dc.date.issued.fl_str_mv |
2013-02 |
dc.date.accessioned.fl_str_mv |
2017-12-07T05:02:24Z |
dc.date.available.fl_str_mv |
2017-12-07T05:02:24Z |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.citation.fl_str_mv |
ROMERO, Gustavo Adolfo Sierra. Clinical research monitoring: scenarios and challenges. Revista da Sociedade Brasileira de Medicina Tropical, Uberaba, v. 46, n. 1, p. 03-06, jan./fev. 2013. DOI: http://dx.doi.org/10.1590/0037-868217342013. Disponível em: https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822013000100003&lng=en&tlng=en. Acesso em: 10 set. 2020. |
dc.identifier.uri.fl_str_mv |
http://repositorio.unb.br/handle/10482/28688 |
dc.identifier.doi.pt_BR.fl_str_mv |
https://dx.doi.org/10.1590/0037-868217342013 |
identifier_str_mv |
ROMERO, Gustavo Adolfo Sierra. Clinical research monitoring: scenarios and challenges. Revista da Sociedade Brasileira de Medicina Tropical, Uberaba, v. 46, n. 1, p. 03-06, jan./fev. 2013. DOI: http://dx.doi.org/10.1590/0037-868217342013. Disponível em: https://www.scielo.br/scielo.php?script=sci_arttext&pid=S0037-86822013000100003&lng=en&tlng=en. Acesso em: 10 set. 2020. |
url |
http://repositorio.unb.br/handle/10482/28688 https://dx.doi.org/10.1590/0037-868217342013 |
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eng |
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eng |
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openAccess |
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Sociedade Brasileira de Medicina Tropical - SBMT |
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Sociedade Brasileira de Medicina Tropical - SBMT |
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Universidade de Brasília (UnB) |
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UNB |
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Repositório Institucional da UnB |
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http://repositorio2.unb.br/jspui/bitstream/10482/28688/2/ARTIGO_ClinicalResearchMonitoring.pdf |
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