Examinando por Materia "Ensayos clínicos"

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    Ítem
    La viabilidad jurídica del uso de psilocibina en contextos experimentales clínicos en Colombia
    (Universidad EAFIT, 2023) Tovar Bermeo, Manuela; Barboza Vergara, Antonio Carlos; Guillén Burgos, Hernán Felipe
    This research aims to study the legal feasibility of conducting clinical experimental studies in Colombia with psilocybin for the treatment of major depressive disorder, based on the analysis of the relevant national regulations on human research. For this purpose, a review of medical literature focused on systematic reviews that gather the best available scientific evidence regarding the safety and efficacy of psilocybin in the treatment of depression is presented, and the current regulations regarding the regulation of psychedelics, as well as those related to clinical experimental trials, are studied. Thus, by integrating this information, the feasibility of using psilocybin in clinical experimental settings is studied and the importance of this type of research is highlighted.
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    Publicación
    Régimen de responsabilidad aplicable a los daños derivados de ensayos clínicos en Colombia : breves reflexiones y propuestas para su delimitación
    (Universidad EAFIT, 2022) Castaño Echeverry, Juan Felipe; Villa Henríquez, Ana Isabel
    In Latin America, Colombia is one of the countries with the highest numbers of clinical trials being carried out. Despite the importance of the country in the clinical research scenario, there is little regulation that, at the national level, deals with the possible adverse consequences of this activity and the applicable liability regime. This article aims, first of all, to briefly outline the main characteristics of clinical trials, focusing on those that involve the application of molecules or drugs and highlighting the actors who take part in said trials. Subsequently,; Colombian regulations will be critically examined, specifically those referring to liability for damages derived from clinical trials; and a contrast will be made with the regulation of some countries in this matter. Finally, some reflections will be proposed aimed at the coherent structuring of a civil liability regime applicable to damages derived from clinical trials.