2021, Number 3
How to ensure the quality of clinical trials in the pandemic stage
Álvarez GS, Rodríguez AJ, Saborido ML, González HZ, Riquelme AI
Full text
Language: Spanish
References: 5
Page: 1-9
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ABSTRACT
Introduction. The course of the pandemic (COVID-19) in Cuba has gone through a favorable scenario, the result of the joint effort, placing science at the service of health. The National Coordinator Center for Clinical Trials (CENCEC), a scientific entity that controls and carries out clinical trials, has as its premise, to ensure the quality of these investigations, with emphasis during the epidemic, where the scenario changes. To show the actions of CENCEC, to ensure the quality of clinical trials in the pandemic stage. Methods. A group analysis and brainstorming was carried out, where the impact of the context of the organization (pandemic stage) on the quality of clinical trials was analyzed, to specify the lines where the work should be reinforced to ensure quality, based on from this, actions were designed to avoid deficiencies. Results. The following were identified as lines: the conception of new clinical trials, the work with the trials started, the fulfillment of the audit program, the training of the personnel and the maintenance of the external certifications granted. Five actions were established, with which it was possible to incorporate four experts in clinical trials, to the temporary work group of the MINSAP, to establish in writing the guidelines for the work with the initiated clinical trials, to comply with 88% of the audit program, to design and give a virtual course and renew the certification of the CENCEC Quality Management System. Conclusions. The actions contributed to ensuring the quality of clinical trials during the pandemic.REFERENCES