Clinical research monitoring: scenarios and challenges

Revista da Sociedade Brasileira de Medicina Tropical

IATS/CNPq, Porto Alegre, Brazil¹  Romero, Gustavo Adolfo Sierra¹  Universidade de Brasília, Brasília¹ 

关键词: Clinical research;    Clinical monitoring;    Clinical trials;    Ethics;    Good clinical practices;   

DOI  :  10.1590/0037-868217342013

学科分类：农业科学（综合）

来源: Sociedade Brasileira de Medicina Tropical

【 摘 要 】

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.Key words: Clinical research; Clinical monitoring; Clinical trials; Ethics; Good clinical practices

【 授权许可】

Unknown