Fernandez-Gonzalez L, Bravo VP, Russo NM, Sepulveda D

Language: Spanish
References: 22
Page: 1-12
PDF size: 447.53 Kb.

ABSTRACT

Latin America was during November 2020 one of the most affected regions by the COVID-19 pandemic in terms of prevalence and deaths attributed to the virus. Therefore, the start of vaccine testing in citizens of the region was received with high expectations about its effectiveness. Therefore, it is essential to take into account certain fundamental principles that should guide this process ensuring its correct implementation. The objective of this article is to provide considerations on the process of implementing clinical trials and post-trial access to COVID-19 vaccines in Latin America, in particular those related to respect for the dignity of participants, the historical global and regional tensions regarding the political economy of clinical trials, some aspects of global governance and the role of the World Health Organization in the pandemic, and the need to ensure post-trial access to the vaccine. It is concluded that the pandemic is an opportunity to strengthen bonds of cooperation and solidarity between Latin American countries. Clinical trials are a key instance to strengthen local and regional governance with a view to consolidate transparency and monitoring of the correct implementation of public-private partnerships in the development of therapies, in which the World Health Organization and the Pan American Health Organization have an important role for the implementation of integration strategies and access to vaccines.

REFERENCES

1. Fuentes F, Ojeda JM. Covid-19 en América Latina: Seis países en el top 10 de mayor tasa de mortalidad. La Tercera. 2020 [acceso 15/11/2020]. Disponible en: Disponible en: https://n9.cl/jpdn4 1.

2. Fernández González L, Bravo Valenzuela P. Expertos y redes sociales: ¿Cómo comunicarnos en tiempos de pandemia?. Revista médica de Chile. 2020;148(4):560-1. Disponible en: DOI: 10.4067/s0034-98872020000400560

3. Latinoamérica Piensa. Chile Iniciará Ensayos Clínicos De Una Vacuna China Contra El Coronavirus. Latinoamérica Piensa. 2020 [acceso 17/08/2020]. Disponible en: Disponible en: https://latinoamericapiensa.com/chile-iniciara-ensayos-clinicos-de-una-vacuna-china-contra-el-coronavirus/26503/ 3.

4. Boivin A, Richards T, Forsythe L, Grégoire A, L'Espérance A, Abelson J, et al. Evaluating patient and public involvement in research BMJ. 2018 [acceso 01/05/2022];363:k5147. Disponible en: Disponible en: https://www.bmj.com/content/363/bmj.k5147.full 4.

5. Strassle CL, Pearson SD. A proposed framework for patient engagement throughout the broader research enterprise. J Comp Eff Res. 2020;9(6):387-393. DOI: 10.2217/cer-2019-0175

6. Borgoño Barros C. Bioética global y derechos humanos: ¿Una posible fundamentación universal para la bioética? Problemas y perspectivas. Acta bioethica. 2009 [acceso 01/05/2022];15(1):46-54. DOI: 10.4067/S1726-569X2009000100006

7. Asociación de Sociedades Científicas Médicas de Chile. Por la salud de los chilenos: El derecho a participar en ensayos clínicos. Chile: SOCHINF; 2020 [acceso 10/08/2020] Disponible en: Disponible en: http://www.sochinf.cl/portal/templates/sochinf2008/documentos/2020/Declaracion%20Soc%20Cientificas%20e%20Investigacion%20jul%2025.pdf 7.

8. US Food and Drug Administration. Right to try. EE. UU.: FDA; 2020 [acceso 10/08/2020] Disponible en: Disponible en: https://www.fda.gov/patients/learn-about-expanded-access-and-other-treatment-options/right-try 8.

9. Rettig RA. The Industrialization of Clinical Research. Health affairs. 2000 [acceso 10/08/2020];19(2):129-46. Disponible en: https://www.healthaffairs.org/doi/abs/10.1377/hlthaff.19.2.129

10. Petryna A. When experiments travel: clinical trials and the global search for human subjects. Princeton. Princeton University Press; 2009.

11. National Comprehensive Cancer Network. Frequently asked questions. 2020 [acceso 10/08/2020]. Disponible en: Disponible en: https://www.nccn.org/patients/resources/clinical_trials/faq.aspx 11.

12. Smart S. The political economy of Latin American conflicts over mining extractivism. The Extractive Industries and Society. 2020 [acceso 01/05/2022];7(2):767-79. Disponible en: Disponible en: https://www.sciencedirect.com/science/article/abs/pii/S2214790X19300760 12.

13. Homedes N, Ugalde A, editors. Clinical Trials in Latin America: Where Ethics and Business Clash. Cham: Springer; 2014.

14. Abhyankar P, Volk RJ, Blumenthal-Barby J, Bravo P, Buchholz A, Ozanne E, et al. Balancing the presentation of information and options in patient decision aids: an updated review. BMC medical informatics and decision making. 2013 [acceso 01/05/2022];13(2):1-10. Disponible en: Disponible en: https://bmcmedinformdecismak.biomedcentral.com/articles/10.1186/1472-6947-13-S2-S6 14.

15. Pharm-Olam International. Clinical trials in Latin America: a region of diversity, a world of opportunity. Houston: Pharm-Olam International; 2014 [acceso 01/05/2022]. Disponible en: Disponible en: https://www.institutocer.com.ar/images/blog/latam-clinical-trials.pdf 15.

16. World Health Organization. Off-label use of medicines for COVID-19: scientific brief. Geneva: WHO; 2020 [acceso 18/08/2020]. Disponible en: Disponible en: https://apps.who.int/iris/handle/10665/331640 16.

17. Singh JA. COVID-19: Science and global health governance under attack. S AfrMed J. 2020 [acceso 18/08/2020];110(6). Disponible en: Disponible en: http://www.samj.org.za/index.php/samj/article/view/12908 17.

18. Hoffman SJ, Røttingen J-A. Split WHO in two: strengthening political decision-making and securing independent scientific advice. Public Health. 2014 [acceso 06/04/2021];128(2):188-94. Disponible en: Disponible en: https://www.sciencedirect.com/science/article/abs/pii/S0033350613002916 18.

19. Organización de las Naciones Unidas para la Educación, la Ciencia y la Cultura (UNESCO). Statement on COVID-19: Ethical Considerations from a Global Perspective, Statement of the UNESCO International Bioethics Committee (IBC) and the UNESCO World Commission on the Ethics of Scientific Knowledge and Technology (COMEST). París: UNESCO; 2020 [acceso 06/04/2021]. Disponible en: Disponible en: https://unesdoc.unesco.org/ark:/48223/pf0000373115 19.

20. García LY, Cerda AA. Contingent assessment of the COVID-19 vaccine. Vaccine. 2020 [acceso 06/04/2021];38(34):5424-9. Disponible en: https://www.sciencedirect.com/science/article/pii/S0264410X2030854920.

21. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. Jama. 2013 [acceso 06/04/2021];310(20):2191-4. Disponible en: https://jamanetwork.com/journals/jama/article-abstract/176031821.

22. Organización de las Naciones Unidas para la Educación, la Ciencia y la Cultura (UNESCO). UNESCO calls for COVID-19 vaccines to be considered a global public good. París: UNESCO; 2021 [acceso 06/04/2021]. Disponible en: Disponible en: https://en.unesco.org/news/unesco-calls-covid-19-vaccines-be-considered-global-public-good 22.