Clinical research monitoring: scenarios and challenges
Rev. Soc. Bras. Med. Trop
;
46(1): 3-6, Jan.-Feb. 2013.
Artículo
en Inglés
| LILACS
| ID: lil-666785
ABSTRACT
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.
Texto completo:
Disponible
Índice:
LILACS (Américas)
Asunto principal:
Derechos del Paciente
/
Investigación Biomédica
Tipo de estudio:
Guía de Práctica Clínica
Límite:
Humanos
Idioma:
Inglés
Revista:
Rev. Soc. Bras. Med. Trop
Asunto de la revista:
Medicina Tropical
Año:
2013
Tipo del documento:
Artículo
País de afiliación:
Brasil
Institución/País de afiliación:
Universidade de Brasília/BR
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