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ISSN 1527-3172 (Electronic)

2016, Number 3

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MEDICC Review 2016; 18 (3)

The ABCs of clinical trials in Cuba

Gorry C

Language: English
References: 16
Page: 9-14
PDF size: 199.51 Kb.


Text Extraction

In 1981, Cuba’s biotechnology sector was born when Cuban scientists, trained by Finnish colleagues, successfully isolated large quantities of human leukocyte interferon alpha. Within a decade and following a $1-billion dollar investment by the Cuban government, 52 scientifi c research institutions were established in and around Havana to develop vaccines, therapies and other medical applications to meet demands of the national health system.
The strategy—based on a “closed loop” approach whereby research, development, manufacturing, clinical trials, marketing, and postmarketing surveillance are coordinated by a single research institute in cooperation with others—has the fi rst priority of forging eff ective solutions to Cuba’s most pressing health problems. Its second priority was, and is, to generate profi ts from sales abroad, which are largely plowed into further R&D and infrastructure, to make the industry independent of government fi nancing over time.


REFERENCES

  1. For a detailed explanation of this strategy, see “Connecting Science to Population Health: The ‘Closed Loop’ Approach,” by Augustín Lage, MEDICC Rev. 2007 Fall;9(1):48.

  2. For complete list of Cuban biotech WIPO Gold Medal Award winners, see http://www.ocpi.cu./sites/default/fi les/archivos_a_vincular/medallasoro.pdf

  3. Pascual MA, Jimenez G, Torres A, Fors MM, López I. Cuba’s National Clinical Trials Coordinating Center: Emergence, Evolution and Main Results. MEDICC Rev [Internet]. 2010 Apr-Jun [cited 2016 Jun 21];13(1):46–51. Available from: http://www.medicc.org/mediccreview/index.php?issue=15&id=184&a=va

  4. Ministry of Public Health (CU). Anuario Estadístico de Salud, 2015. Havana: Ministry of Public Health (CU). 2016. Spanish.

  5. Pascual MA. Los ensayos clínicos en Cuba: Impacto en la biotecnología y en la salud pública [unpublished Master’s thesis]. [Havana]: [place unknown]; 2013. Spanish.

  6. 6.World Health Organization. Cuban experience with local production of medicines, technology transfer and improving access to health. Geneva: World Health Organization; 2015.

  7. Suarez G, Cabanas R, Zaldívar M, Garnier T, Iglesias B et al. Clinical Experience with Nimotuzumab in Cuban Pediatric Patients with Brain Tumors, 2005 to 2007. MEDICC Rev [Internet]. 2009 Summer [cited 2016 17 Jul]; 11(3):27–33. Available from: http://www.medicc.org/mediccreview/index .php?issue=9&id=102&a=va

  8. Granma Internacional. Clinical trials of promising Cuban monoclonal antibody expanded. Granma [Internet]. 2016 Apr 7 [cited 2016 Jun 21]. Available from: http://en.granma.cu/cuba/2016-04-07/clinical-trials-of-promising-cuban-mono clonal-antibody-expanded

  9. EFE. Cuba begins 3rd phase of clinical trials of treatment for prostate cancer. EFE [Internet] 2015 Aug 19 [cited 2016 Jul 4]. Available from: http://www.efe.com/efe/english/life/cuba-begins-3rd-phase-of-clinical-trials-treatment-for -prostate-cancer/50000263-2691573

  10. Rodríguez PC, Rodríguez G, González G, Lage A. Clinical Development and Perspectives of CIMAvax-EGF, Cuban Vaccine for Non-small-cell Lung Cancer Therapy. MEDICC Rev [Internet]. 2010 Winter [cited 2016 Jun 4]; 12(1):17–23. Available from: http://www.medicc.org/mediccreview/index .php?issue=11&id=128&a=va

  11. Gorry C. Cuba’s Complex Respiratory Picture. Lancet Resp Med. 2015 Sept; 3.

  12. Lee K. A small boat in a large ocean: One US cancer center’s ongoing journey to bring Cuban cancer vaccines to American patients [PowerPoint presented at the 14th Edition of the Series of Conversations: Cuba in US Foreign Policy]; Havana: 2015 Dec 16.

  13. Raices Pérez-Castañeda M. Papel de la organización superior de desarrollo empresarial BioCubaFarma en la concreción dentro de la sociedad cubana de proyectos biotecnológicos orientados al benefi cio social [PowerPoint]; 2015. Spanish.

  14. Berlanga J. Fernández JI, López E, López PA, del Río A, et al. Heberprot- P: A Novel Product for Treating Advanced Diabetic Foot Ulcer. MEDICC Rev [Internet]. 2013 Jan [cited 2016 Jul 3]; 15(1):11–5. Available from: http://www .medicc.org/mediccreview/index.php?issue=23&id=287&a=va

  15. Reed GA. Let’s open the door to Cuba and its promising diabetes treatments. SF Chronicle [Internet]. 2016 Mar 17 [cited 2016 Jul 16]. Available from: http:// www.sfchronicle.com/opinion/article/Let-s-open-the-door-to-Cuba-and-its -promising-6921055.php

  16. Arrencibia-Jorge R, Corera-Alvarez E, Chinchilla-Rodríguez Z, de Moya- Anegón F. Scientifi c output of the emerging Cuban biopharmaceutical industry: a scientometric approach. Scientometrics. 2016 May. DOI: 10.1007/s11192- 016-2023-1




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