medigraphic.com
ISSN 1028-4818 (Electronic)

2015, Number S1

<< Back Next >>

Mul Med 2015; 19 (S1)

The clinical investigation. Manzanillo. 2014

Piquet RNM, Roselló SO, Méndez JO, Gutiérrez SE

Language: Spanish
References: 21
Page: 1-13
PDF size: 184.70 Kb.


ABSTRACT

Introduction: the accelerated development of the Cuban Medical Pharmaceutical Industry imposed the need to create structures that guarantee the clinical evaluation of products for its integration to the medical practice and posterior commercialization.
Objective: to describe the main advances of the National Coordinating Center of Clinical Trials (NCCCT) and the National Coordinating Net in relation to the design and performance of the clinical trials, as well as the main work directions coordinated by this institution.
Method: it was accomplished a bibliographic revision in scientific papers, chapters of books, documents and websites related with the performance of clinical trials, as well as technical reports and unpublished data, generated in the process of work of the provincial coordinator in Granma in the year 2014.
Results: the most relevant are the sanitary registers of an important group of biotechnological and pharmaceutical products since this activity started up in 1991 in the provinces; the active participation of the health system in the program of clinical trials, and the modification of health indicators.
Conclusions: the most authentic sample of the objectives achievement since the beginning is the amount of finished clinical trials, the active participation of the health system in the program of clinical trials and the modification of health indicators.


REFERENCES

  1. Suzuki C, Jacobson H, Hatschek T, Torkzad MR, Boden K, Erikson-Alm Y, et al. Radiologic measurements of tumor response to treatment: practical approaches and limitations. Radiographics [Internet]. 2008 [citado 20 Jul 2014]; 28(2). Disponible en: http://www.ncbi.nlm.nih.gov/pubmed/18349443

  2. Armitage P. Bradford Hill and the randomized controlled trial. Pharmaceut Med 1992; 6: 23-7

  3. Hil TP. Phase 0 trials: Are they ethicalle challenged? Clin Cancer Research. 2007; 13: 783.

  4. Humanismo, educación y cultura. México: El Colegio Nacional; 1978.

  5. Perdomo Leyva D. Los ensayos clínicos terapéuticos. MEDISAN [Internet] 2004 [citado 24 de abril del 2013]; 8(2). Disponible en: http://bvs.sld.cu/revistas/san/vol8_2_04/san01204.htm

  6. Simeón R Elena. La ciencia y la tecnología en Cuba. Rev Cubana Med Trop [Internet]. 1997 Dic [citado 23 de octubre de 2014]; 49(3): 153-160. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0375-07601997000300001&lng=es.

  7. Aguirre F. Las Buenas Prácticas Clínicas en los sitios de investigación. Rev Méd Electrón [Internet]. 2008 sept-oct [citado 23 de julio 2013]; 30(5). Disponible en: http://www.revmatanzas.sld.cu/revista%20medica/ano%202008/vol5%202008/revista%20medica%20vol5%202008.htm

  8. Pascual López María Amparo, Jiménez Rivero Gladys, Torres Pombert Ania, Fors López Martha María, López Zayas Isabel. Surgimiento, evolución y principales resultados del Centro Nacional Coordinador de Ensayos Clínicos. Rev Cubana Farm [revista en la Internet]. 2011 Mar [citado 2015 Jun 17]; 45(1): 4-18. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152011000100002&lng=es.

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

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

  11. Pascual M, Jiménez G, Torres A, Fors M, López I. Surgimiento, evolución y principales resultados del Centro Nacional Coordinador de Ensayos Clínicos. Rev Cubana Farm [Internet]. 2011 Mar [citado 2014 Mayo 28]; 45(1): 4-18. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152011000100002&lng=es.

  12. Cruz-Coke MR. Introducción de la bioética en la medicina contemporánea. Rev Med Chile 1995; 123(3):363-7.

  13. Figueroa CG. ¿Por qué bioética hoy? Rev Med Chile 1995; 123(6):777-84.

  14. Patlak P, Nass S. Inproving the Quality of Cancer trials summary. Washington: National Academies Press; 2008.

  15. Kinders RJ. Preclinical modeling of phase 0 clinical trials. Qualification of a pharmacodynamic assay of poly (ADP-Ribose) polimerase in tumor biopsies of mouse xenografts. Clin Cancer Rerearch 2008; 14(21): 6877-85.

  16. Patlak P, Nass S. Inproving the Quality of Cancer trials summary. Washington: National Academies Press; 2008.

  17. Lage Dávila Agustín. El doble paradigma de la investigación clínica. Rev Cubana Farm [revista en la Internet]. 2011 Mar [citado 2015 Jun 17]; 45(1): 1-3. Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0034-75152011000100001&lng=es.

  18. Pocock SJ. Clinical Trial: a practical approach. Chichester: John Wiley and Sons; 2004.

  19. La Organización de los Ensayos Clínicos en Cuba. Los Ensayos Clínicos Multicéntricos. Varadero: CENCEC; 2003.

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

  21. Patlak P, Nass S. Inproving the Quality of Cancer trials summary. Washington: National Academies Press; 2008.




2020     |     www.medigraphic.com