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Sociedade Brasileira de Medicina Tropical - SBMT, Revista da Sociedade Brasileira de Medicina Tropical, 1(46), p. 03-06

DOI: 10.1590/0037-868217342013

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Clinical research monitoring: scenarios and challenges

Journal article published in 2013 by Gustavo Adolfo Sierra Romero ORCID, Romero,Gustavo Adolfo Sierra
This paper is made freely available by the publisher.
This paper is made freely available by the publisher.

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Postprint: policy unknown
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Data provided by SHERPA/RoMEO

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.