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Revista de la OFIL
versión On-line ISSN 1699-714Xversión impresa ISSN 1131-9429
Resumen
RODRIGUEZ-ALVAREZ, J et al. Actions of the Cuban National Health System for clinical investigations during the COVID-19 pandemic. Rev. OFIL·ILAPHAR [online]. 2022, vol.32, n.1, pp.83-86. Epub 21-Nov-2022. ISSN 1699-714X. https://dx.doi.org/10.4321/s1699-714x20220001000015.
Introduction:
The infestation and mortality caused by the Sarv-Cov-2 (COVID-19) coronavirus led health systems to develop actions to promote new clinical research aimed at having effective treatment schemes for better management of this disease.
In Cuba, with the existence before the pandemic, of a clinical trial plan and the need to promote new ones, to deal with COVID-19; it was proposed to develop a system of actions aimed at preserving their quality.
Objective:
Describe the main actions developed by the Cuban National Health System for the development of clinical research during the pandemic.
Methods:
A bibliographic review was carried out on the main regulatory websites and those related to the topic of clinical research in the pandemic stage of COVID-19. The results achieved were taken into account to propose an own action system, aimed at supporting clinical trials.
Results:
Actions were established in three lines of work: ethical support, regulatory requirements for modifications to ongoing and new studies, and the control of clinical trials. The work system was made up of 29 actions aimed at ensuring that clinical trials have ethical support, comply with regulatory requirements in terms of methodological, design aspects and their control to guarantee compliance with Good Clinical Practices.
Palabras clave : Actions; clinical investigations; COVID-19.