2012, Number 3
Quality in the design of the clinical trial in Natural and Traditional Medicine
Language: Spanish
References: 13
Page:
PDF size: 43.43 Kb.
ABSTRACT
The Natural and Traditional Medicine has entered a new stage of development with the striking increase of the therapeutic alternatives demand. One of its limitations is the scarcity of researches, done applying the scientific method to acquire and evaluate the obtained results or the incorrect design of the research, mainly in those including the evaluation of agents, therapeutic procedures or diagnosis of Natural and Traditional Medicine, through clinical trials. With the objective of assessing the quality of the methodological design of the clinical trials of Natural and Traditional Medicine we carried out a cross-sectional, descriptive research to evaluate the clinical trials protocols of the Master´s defenders and residents of this specialty, from July to November 2011. We analyzed in total 36 protocols of clinical trials. The main problems detected were: 41,7 % of the trials did not add relevant information; 80,5 % had problems in the design; in 22,2 % of them there was a lack of previous clinical information justifying the beginning of the trial, and 16, 7 % did not fulfilled the ethical aspects of a clinical trialREFERENCES
Pascual MA, Jiménez G, Fors M, López I, Rodríguez O, Torres A, et al. La organización de los ensayos clínicos en Cuba: influencia en el desarrollo de los productos de la industria médico-farmacéutica y biotecnológica y en el Sistema de Salud de Cuba. Premio Anual de la Salud, Concurso Nacional. Enero; 2010.
Pascual MA, Jiménez G, Torres A, Fors MM, López I. Surgimiento, evolución y principales resultados del Centro Nacional Coordinador de Ensayos Clínicos. Rev Cubana Farm [Internet]. 2011 [citado 12 Dic 2011];45(1). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_abstract&pid=S0034-75152011000100002&lng=es&nrm=iso&tlng=es.