Abstract

AVILA ALBUERNE, Yisel et al. Ethics in the design, conduction and monitoring of clinical trials with SURFACEN® in Cuba. AMC [online]. 2015, vol.19, n.2, pp. 138-147. ISSN 1025-0255.

Background: the Coordinating National Center of Clinical Trial, the National Center of Agricultural Health and the Cuban intensive care units carried out clinical trials with SURFACEN® to treat respiratory distress syndrome. Objective: to describe the ethical in the design, conduction and monitoring of these clinical trials, as well as determine its internal and external validity. Methods: a descriptive, prospective study was conducted between 2004 and 2014. Protocols, data collecting notebooks and informed consent were designed; clinical sites, human and material resources were planned; clinical investigators were trained; also, the implementation of clinical trials stages II, III, and IV that evaluated the effect, effectiveness and security of SURFACEN® to treat respiratory distress syndrome in three population groups: newborn babies, infants, children (up to 18 years old) and adults, was monitored. Results: forty-one intensive care units participated (17 of neonatology, 7 for pediatric patients and 17 for adults), 1 413 patients were evaluated and 306 were included and 709 health professionals were trained in Good Clinical Practice. The performance of the ethical norms for the investigation in human beings could be shown in the monitoring, the revision of the documentation and the carried-out procedures. The internal validity of the results could be shown through the objectivity of the observation, the recurrent comparison and the random assignment of treatments, and through the planning and performance according to the Guides of Good Clinical Practice. The external validity could be shown in the change of the legislation of the product with the approval of three new indications: for the acute respiratory distress syndrome in pediatric patients and adults and for preterm babies with an early use (two hours old).    Conclusions: the design, conduction and monitoring of clinical trials with SURFACEN® performed the basic ethical principles for the clinical investigation and guaranteed the internal and external validity of the results.

Keywords : RESPIRATORY DISTRESS SYNDROME, ADULT; CLINICAL TRIAL, PHASE II; THERAPEUTIC USES; ETHICS; EPIDEMIOLOGY, DESCRIPTIVE.

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