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2011, Number 1

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MEDICC Review 2011; 13 (1)

Cuba’s national clinical trials coordinating center: Emergence, evolution, and main results

Pascual MA, Jiménez G, Torres A, Fors MM, López I
Full text How to cite this article

Language: English
References: 10
Page: 46-51
PDF size: 143.11 Kb.


Key words:

contract research organization, clinical evaluation, drug industry, clinical trial, Cuba.

ABSTRACT

The rapid development of Cuba’s pharmaceutical industry in the 1990s created a need for structures to ensure clinical evaluation of products before their introduction into medical practice and subsequent marketing. One of the centers founded for this purpose was the National Clinical Trials Coordinating Center. This paper summarizes the factors that motivated the creation of the Center and presents a brief history of its organizational development over the last 17 years. It also describes the main components of the system for designing and conducting clinical trials, and the most signi cant contributions of each toward achieving the Center’s objectives.


REFERENCES

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  3. Pascual MA, Jiménez G, Fors M, López I, Rodríguez O, Torres A et al. La Organización de los Ensayos Clínicos en Cuba: In uencia en el desarrollo de los productos de la Industria Médico- Farmacéutica y Biotecnológica y en el Sistema de Salud de Cuba. Premio Anual de la Salud, Concurso Nacional. Jan 2010.

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  9. Los Ensayos Clínicos Multicéntricos. La Organización de los Ensayos Clínicos en Cuba. Resumen del II Taller internacional de Diseño y conducción de Ensayos Clínicos. Varadero: CENCEC, 2003.

  10. Organización Panamericana de Salud. Buenas Prácticas Clínicas: Documento de las Américas. OPS [cited 12 Jan 2009]. Available from: http:// www.paho.org/spanish/ad/ths/ev/GCPSp-hp.htm.




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MEDICC Review. 2011;13