Clinical research monitoring : scenarios and challenges

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Autor(es): dc.creatorRomero, Gustavo Adolfo Sierra-
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Descrição: dc.descriptionClinical 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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Idioma: dc.languageen-
Publicador: dc.publisherSociedade Brasileira de Medicina Tropical - SBMT-
Direitos: dc.rightsAcesso Aberto-
Direitos: dc.rightsRevista 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: Acesso em: 10 set. 2020.-
Palavras-chave: dc.subjectMedicina - pesquisa-
Palavras-chave: dc.subjectMonitoramento clínico-
Palavras-chave: dc.subjectEnsaio clínico-
Palavras-chave: dc.subjectÉtica-
Título: dc.titleClinical research monitoring : scenarios and challenges-
Tipo de arquivo: dc.typelivro digital-
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