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Revista Cubana de Farmacia

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2011, Number 1

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Rev Cubana Farm 2011; 45 (1)

Emergence, development and main results of the National Coordinating Center of Clinical Trials

Pascual LMA; Jiménez RG; Torres PA; Fors LMM; López ZI
Full text How to cite this article

Language: Spanish
References: 10
Page: 4-18
PDF size: 88.40 Kb.


Key words:

Center of research under contract, clinical evaluation, medical pharmaceutical Industry, clinical trials, Cuba.

ABSTRACT

The fast development of the Cuban pharmaceutical industry in the 90´s prompted the creation of structures to assure the clinical evaluation of products for their introduction into the medical practice and their further marketing. The National Coordinating Center of Clinical Trials was one of the most important centers founded to accomplish these objectives. The present paper showed in short the reasons behind the emergence of this center and its organizational development for more than 17 years. It also described the main components of the design and the conduction of clinical trials as well as their most significant contributions to fulfill the set objectives.


REFERENCES

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  2. Calva-Mercado JJ. Estudios clínicos experimentales. Sal Púb Méx. 2000;42(4).

  3. Pascual MA, Jiménez G, Fors M, López I, Rodríguez O, Torres A, et al. La organización de los ensayos clínicos en Cuba: Influencia 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. Enero, 2010.

  4. Friedman LM, Furberg CD, DeMets DL. Fundamentals of clinical trials. 2da ed. Littleton: PSG Publishing Company; 1985.

  5. Laporte JR. Principios Básicos de Investigación Clínica. Barcelona: Ergon SA; 1993.

  6. ICH Harmonised Tripartite Guideline. ICH E8 General considerations for clinical trials. Geneva: ICH Steering Committee; 1997.

  7. Schuchman M. Comercializing Clinical Trials _ Risks and Benefits of the CRO Boom. N Engl J Med. 2007;357(14):1365.

  8. Lage A. Connecting immunology research to public health: Cuban biotechnology. Nature Immunol. 2008;9(2):109-12.

  9. Los Ensayos Clínicos Multicéntricos. La Organización de los Ensayos Clínicos en Cuba. Libro 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 [citado 12 ene 2009]. Disponible en: http://www.paho.org/spanish/ad/ths/ev/GCPSp-hp.htm




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C?MO CITAR (Vancouver)

Rev Cubana Farm. 2011;45