Participación de las mujeres en los ensayos clínicos según los informes de la Agencia Española de Medicamentos y Productos Sanitarios: 2007

Abstract

RESUMENFundamento: la información sobre la participación de hombres y mujeres en los ensayos clínicos que afectan a la población general no parece estar aún suficientemente extendida en el ámbito de la comunidad científica. El objetivo del estudio ha sido la valoración aproximativa de la situación en España acerca del tratamiento de los datos de los ensayos clí-nicos en el momento de publicación de la Ley de Igualdad.Métodos: Se revisaron los apartados de diseño, población de estudio, datos demográficos y características básales de los sujetos participantes, resultados y conclusiones del ensayo en los resúmenes de los informes finales de los ensayos clínicos recibidos durante el primer cuatrimestre de 2007 en la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Resultados:De los 25 documentos analizados 5 desagregan datos por edad y sexo, 13 no aportan ningún dato desagregado por sexo ni ninguna conclusión, 3 tampoco expresan los resultados desagregados por sexo pero sí describen por esta variable los acontecimientos adversos graves, y en 4 no se encuentran ni resultados ni conclusiones.Conclusiones: Sólo el 20% de los resúmenes revisados proporciona datos desagregados por sexo. Esto podría deberse a que no se haya hecho o que no se le haya dado la suficiente importancia como para incluirlo en el resumen, lo que tampoco es satisfactorio. Un estudio más amplio es difícil dada la calidad actual de los resúmenes de los informes finales de ensayos, que es el único documento obligatorio remitir a la AEMPS una vez concluido el ensayo.Palabras clave: Ensayo clínico. Mujeres. Sesgo de Género. ABSTRACT Women Participation in Clinical Trials. A Preliminary Study in the Files of the Spanish Agency for Medicinal Products and Medical DevicesBackground: The evaluation of the gender bias in clinical trials is not unanimous. The aim of this study has been the assessment of the current situation in Spain regarding the manipulation of data from clinical trials at the publication of the Law of Equality. Methods:We have examined the study design, sample population, demographic data and baseline clinical characteristics of participants, results and conclusions of the trial in the summaries of the final reports of clinical trials received in the first four months of 2007 in the Agencia Española de Medicamentos y Productos Sanitarios.Results: From twenty-five documents analysed, in their results and conclusions: Five subdivide data sets by age and gender, thirteen do not subdivide data by gender nor do they provide a conclusion, three do not subdivide results neither but do describe severe side effect by gender and four others provide no results or conclusions. Conclusions:Only twenty percent of the reviewed summaries provide data subdivided by gender. This could be due to the fact that it has not been made or that it was not given enough importance to include it in the summary, neither of which is satisfactory. A more detailed study is difficult due to the current quality of the summaries provided of the final reports ...

Self-care interventions of community-dwelling older adults: a systematic review and meta-analysis

“…The sample of this study was mainly females (around 65%) with an average age of 75 years, hence they belong to the classification of “ageing” group ( 34 ). Usually, in research with older populations, the profile of greater participation of females is repeated, as well as the practice of forming samples with both males and females, but in the analysis of the results no studies have been found that disaggregate data by sex ( 35 ). However, the topic of “self-care” needs specific programs for men and women due to the cultural tradition of associating care practice with females as opposed to males ( 36 ).…”

“…Frontiers in Public 09 frontiersin.org data by sex (35). However, the topic of "self-care" needs specific programs for men and women due to the cultural tradition of associating care practice with females as opposed to males (36).…”