{"id":26967,"date":"2021-06-14T09:44:17","date_gmt":"2021-06-14T08:44:17","guid":{"rendered":"https:\/\/faus-moliner.com\/real-world-data-think-big\/"},"modified":"2021-06-21T09:46:58","modified_gmt":"2021-06-21T08:46:58","slug":"real-world-data-think-big","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/real-world-data-think-big\/","title":{"rendered":"Real World Data: Think Big"},"content":{"rendered":"\n<p>Hoy voy a hablarles de la importancia de los llamados \u201cDatos de la Vida Real\u201d (Real World Data), a prop\u00f3sito de una reciente iniciativa de la EMA: la \u201c<strong>D<\/strong>ata <strong>A<\/strong>nalysis and <strong>R<\/strong>eal <strong>W<\/strong>orld <strong>I<\/strong>nterrogation <strong>N<\/strong>etwork\u201d (DARWIN EU). La International Society of Pharmacoeconomics and Outcomes Research (ISPOR) los define como aquellos datos utilizados para la toma de decisiones no obtenidos a partir de ensayos cl\u00ednicos aleatorizados, sino de la pr\u00e1ctica cl\u00ednica. <\/p>\n\n\n\n<p>Estos datos, mayoritariamente provenientes de estudios observacionales, pero tambi\u00e9n de otras variadas fuentes (programas de apoyo a pacientes, registros de casos cl\u00ednicos, etc) son importantes por varios motivos. Tienen un gran potencial para complementar el conocimiento adquirido despu\u00e9s de los ensayos cl\u00ednicos, por lo general limitados a grupos peque\u00f1os y homog\u00e9neos de pacientes en entornos especializados y controlados; ofrecen as\u00ed una imagen m\u00e1s completa de los f\u00e1rmacos estudiados al incluir pacientes de la poblaci\u00f3n general, ayudando a proporcionar mejor conocimiento y respuestas en cuanto a la eficacia y seguridad de los medicamentos; y si estos datos son lo suficientemente relevantes, tambi\u00e9n pueden permitir identificar nuevas indicaciones o condiciones de uso. <\/p>\n\n\n\n<p>En suma, proporcionan una informaci\u00f3n muy valiosa para la toma de las mejores decisiones sobre la salud (no s\u00f3lo en t\u00e9rminos econ\u00f3micos) por parte de todos los agentes implicados. Existen numerosas iniciativas puestas en marcha a ra\u00edz de la actual pandemia sanitaria que lo demuestran. Pero tambi\u00e9n las administraciones sanitarias est\u00e1n llamadas a potenciar desarrollos que permitan el an\u00e1lisis y la gesti\u00f3n de estos datos para favorecer la generaci\u00f3n de todo este conocimiento. <\/p>\n\n\n\n<p>Estos datos ya se est\u00e1n utilizando en el \u00e1mbito de la investigaci\u00f3n, especialmente en la gen\u00f3mica y en la medicina personalizada, pero tambi\u00e9n en el soporte al autocuidado de las personas, como ayuda a los proveedores de servicios m\u00e9dicos, etc, pero su potencial ser\u00e1 seguramente mayor de la mano del \u201cbig data\u201d (an\u00e1lisis de grandes vol\u00famenes de datos) en salud, siempre que se haga con pleno respeto de las normas sobre protecci\u00f3n de datos personales.<\/p>\n\n\n\n<p> En mi opini\u00f3n, cuando m\u00e1s globales sean todas estas iniciativas, mejor. A nivel europeo, ya se hab\u00edan puesto en marcha diferentes experiencias para incorporar el conocimiento procedente de la pr\u00e1ctica cl\u00ednica: el grupo de expertos STAMP (Safe and Timely Access to Medicines for patients) para identificar las maneras de optimizar el uso de las herramientas reguladoras incorporando datos de la vida real, o las licencias adaptativas (Adaptativepathways), que utilizan datos de la vida real para ir modulando el \u00e1mbito de autorizaci\u00f3n de un medicamento a lo largo de su ciclo de vida, por citar algunos. La red \u201cDARWINEU\u201d que ahora est\u00e1 impulsando la EMA tiene precisamente por finalidad promover el intercambio de datos de la vida real, de calidad y a gran escala, sobre el uso, seguridad y eficacia de los medicamentos a nivel de toda la UE. Una muy buena iniciativa que esperamos que ayude a que todos los objetivos antes apuntados se cumplan plenamente.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Hoy voy a hablarles de la importancia de los llamados \u201cDatos de la Vida Real\u201d (Real World Data), a prop\u00f3sito de una reciente iniciativa de la EMA: la \u201cData Analysis and Real World Interrogation Network\u201d (DARWIN EU). La International Society of Pharmacoeconomics and Outcomes Research (ISPOR) los define como aquellos datos utilizados para la toma&#8230; <\/p>\n<div class=\"clear\"><\/div>\n<p><a href=\"https:\/\/faus-moliner.com\/en\/real-world-data-think-big\/\" class=\"excerpt-read-more\">Read More<\/a><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[499,71],"tags":[],"coauthors":[],"class_list":["post-26967","post","type-post","status-publish","format-standard","hentry","category-el-global","category-publications"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.6 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Real World Data: Think Big - Faus Moliner<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/faus-moliner.com\/en\/real-world-data-think-big\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Real World Data: Think Big - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"Hoy voy a hablarles de la importancia de los llamados \u201cDatos de la Vida Real\u201d (Real World Data), a prop\u00f3sito de una reciente iniciativa de la EMA: la \u201cData Analysis and Real World Interrogation Network\u201d (DARWIN EU). La International Society of Pharmacoeconomics and Outcomes Research (ISPOR) los define como aquellos datos utilizados para la toma... 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La International Society of Pharmacoeconomics and Outcomes Research (ISPOR) los define como aquellos datos utilizados para la toma... 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