Role of government in clinical trials

Authors

  • Pilar Mazzetti Centro de Investigación en Neurogenética, Instituto Nacional de Ciencias Neurológicas. Lima, Perú. Facultad de Medicina, Universidad Nacional Mayor de San Marcos. Lima, Perú. Médico neurólogo magister en Gestión Pública.
  • Gustavo Silva-Paredes Maestría en Salud Pública Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III. Madrid, España. médico magister en Salud Pública Internacional.
  • Mario Cornejo-Olivas Centro de Investigación en Neurogenética, Instituto Nacional de Ciencias Neurológicas. Lima, Perú. médico neurólogo.

DOI:

https://doi.org/10.17843/rpmesp.2012.294.396

Keywords:

Clinical trials, randomized, Health public policy, Health care coordination and monitoring

Abstract

The regulation of clinical trials by the Government is a process of continuous change and adaptation, current challenge is to ensure the safety of participants and get balance of administrative procedures. Development and regulation of clinical trials in different countries vary according to the situation, context national or international execution, determining the insufficiency of national regulation requiring review of international regulation. The aim of this publication is to present a comprehensive overview of the role of Government in the regulation of clinical trials in different realities. It includes a review of the regulation in The European Union, The United States and some Latin American countries and finally the regulation in Peru. Contemporary trends in the regulation of clinical trials, are characterized by increasing standards of quality, ensuring the safety of the participants, promote transparency, lower bureaucratic processes and strengthening ethics IRB committees in the framework of open democratic processes, involving all stakeholders in dynamic processes based on current knowledge and changing tendencies. The challenge is to promote the development of clinical trials from the government institutions (universities, research centers, institutes, hospitals, etc.) priorizing local needs including orphan drugs, prevalent and neglected diseases, and therapeutic use of active components of local native plants.

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Published

2014-02-05

Issue

Section

Symposium

How to Cite

1.
Mazzetti P, Silva-Paredes G, Cornejo-Olivas M. Role of government in clinical trials. Rev Peru Med Exp Salud Publica [Internet]. 2014 Feb. 5 [cited 2024 Nov. 13];29(4). Available from: https://rpmesp.ins.gob.pe/index.php/rpmesp/article/view/396

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