{"id":32411,"date":"2024-04-17T11:09:59","date_gmt":"2024-04-17T09:09:59","guid":{"rendered":"https:\/\/www.thema-med.com\/2024\/04\/17\/europa-aggiornata-linea-guida-mdcg-sul-piano-di-indagine-clinica\/"},"modified":"2024-04-18T16:06:14","modified_gmt":"2024-04-18T14:06:14","slug":"europa-aggiornata-linea-guida-mdcg-sul-piano-di-indagine-clinica","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/es\/2024\/04\/17\/europa-aggiornata-linea-guida-mdcg-sul-piano-di-indagine-clinica\/","title":{"rendered":"EUROPA: Se actualiza la directriz del MDCG sobre el plan de investigaci\u00f3n cl\u00ednica"},"content":{"rendered":"<div class=\"fusion-fullwidth fullwidth-box fusion-builder-row-1 fusion-flex-container nonhundred-percent-fullwidth non-hundred-percent-height-scrolling\" style=\"--awb-border-radius-top-left:0px;--awb-border-radius-top-right:0px;--awb-border-radius-bottom-right:0px;--awb-border-radius-bottom-left:0px;--awb-flex-wrap:wrap;\" ><div class=\"fusion-builder-row fusion-row fusion-flex-align-items-flex-start fusion-flex-content-wrap\" style=\"max-width:1144px;margin-left: calc(-4% \/ 2 );margin-right: calc(-4% \/ 2 );\"><div class=\"fusion-layout-column fusion_builder_column fusion-builder-column-0 fusion_builder_column_1_1 1_1 fusion-flex-column\" style=\"--awb-bg-size:cover;--awb-width-large:100%;--awb-margin-top-large:0px;--awb-spacing-right-large:1.92%;--awb-margin-bottom-large:0px;--awb-spacing-left-large:1.92%;--awb-width-medium:100%;--awb-spacing-right-medium:1.92%;--awb-spacing-left-medium:1.92%;--awb-width-small:100%;--awb-spacing-right-small:1.92%;--awb-spacing-left-small:1.92%;\"><div class=\"fusion-column-wrapper fusion-flex-justify-content-flex-start fusion-content-layout-column\"><div class=\"fusion-text fusion-text-1\"><h2>En marzo, el <strong>Grupo de Coordinaci\u00f3n de Productos Sanitarios<\/strong> <strong>(MDCG)<\/strong> public\u00f3 la directriz <a href=\"https:\/\/health.ec.europa.eu\/document\/download\/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en_0.pdf\"><em>Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices<\/em><\/a> que trata de las investigaciones <strong>cl\u00ednicas <\/strong>teniendo en cuenta los \u00faltimos conocimientos t\u00e9cnicos y, en lo que respecta a la seguridad, la relaci\u00f3n beneficio-riesgo de los productos.<\/h2>\n<p>En general, una investigaci\u00f3n cl\u00ednica debe incluir <strong>suficientes<\/strong> <strong>observaciones<\/strong> para garantizar el valor cient\u00edfico y la validez de las conclusiones. Adem\u00e1s, los <strong>procedimientos<\/strong> y <strong>metodolog\u00edas<\/strong> de investigaci\u00f3n utilizados para llevar a cabo la investigaci\u00f3n cl\u00ednica deben ser apropiados para el producto investigado.<\/p>\n<p>En concreto, el <strong>plan de investigaci\u00f3n cl\u00ednica (<em>Clinical Investigation Plan &#8211; CIP<\/em>)<\/strong> define la justificaci\u00f3n, los objetivos, la metodolog\u00eda de dise\u00f1o, la supervisi\u00f3n, la realizaci\u00f3n, el mantenimiento de registros y el m\u00e9todo de an\u00e1lisis de la investigaci\u00f3n cl\u00ednica. El CIP debe ser lo suficientemente <strong>detallado <\/strong>como para servir de manual a quienes lleven a cabo la investigaci\u00f3n cl\u00ednica.<\/p>\n<p>Adem\u00e1s, el CIP debe permitir a las autoridades competentes y a los comit\u00e9s de \u00e9tica evaluar si la investigaci\u00f3n cl\u00ednica se ha dise\u00f1ado de tal manera que los <strong>riesgos potenciales <\/strong>para los sujetos o terceros est\u00e9n justificados en relaci\u00f3n con los beneficios cl\u00ednicos esperados. Por \u00faltimo, el CIP debe permitir evaluar si la fiabilidad y solidez de los datos que se generar\u00e1n en la investigaci\u00f3n cl\u00ednica justifican la exposici\u00f3n de los sujetos al dispositivo experimental y a los procedimientos descritos en el CIP.<\/p>\n<p>El CIP debe contener varios <strong>elementos<\/strong>, como: una descripci\u00f3n resumida del producto en investigaci\u00f3n, una descripci\u00f3n de los beneficios potenciales de la investigaci\u00f3n y de los riesgos a los que se expondr\u00e1n los sujetos durante su participaci\u00f3n en la investigaci\u00f3n cl\u00ednica, la finalidad de la investigaci\u00f3n cl\u00ednica, declaraciones relativas al rendimiento cl\u00ednico, la eficacia o la seguridad del producto en investigaci\u00f3n que se va a probar, los criterios de selecci\u00f3n, el tama\u00f1o de la poblaci\u00f3n que se va a investigar, informaci\u00f3n sobre los sujetos vulnerables implicados, como ni\u00f1os, mujeres embarazadas, sujetos inmunodeprimidos o ancianos.<\/p>\n<p>Entre otros aspectos, se se\u00f1ala en particular que dentro del plan de investigaci\u00f3n cl\u00ednica debe quedar patente que la autoridad competente debe ser informada de cualquier cambio propuesto que pueda tener un impacto sustancial en la seguridad, la salud o los derechos de los sujetos.<\/p>\n<p>Estos son s\u00f3lo algunos de los aspectos abordados en la directriz del MDCG.<\/p>\n<p><strong>&gt;&gt;&gt;<\/strong>\u00a0A trav\u00e9s de los servicios de <strong>\u00a0<\/strong><a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/consulenza-strategico-regolatoria-dispositivi-medici-medical-devices\/\"><strong>Consultor\u00eda estrat\u00e9gica-normativa<\/strong>, <\/a>asistencia para la\u00a0<a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/supporto-alla-certificazione-ce-dispositivi-medici-ivd\/\"><strong>certificaci\u00f3n CE<\/strong><\/a> y, si necesario, <a href=\"https:\/\/www.thema-med.com\/servizi-consulenza-strategico-regolatoria-aziende-dispositivi-medici-strumenti-medicali-dispositivi-medico-diagnostici-in-vitro\/local-representative-mercati-esteri\/servizio-rappresentante-autorizzato-europeo\/\"><strong>Rapresentante Europeo Autorizado<\/strong><\/a>, Thema puede ayudarle a aplicar los requisitos del Reglamento MDR (UE) 2017\/745.<\/p>\n<p><strong>Fuente<\/strong><\/p>\n<p><a href=\"https:\/\/health.ec.europa.eu\/document\/download\/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en_0.pdf\">Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices<\/a><\/p>\n<\/div><\/div><\/div><\/div><\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":115,"featured_media":32369,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"footnotes":""},"categories":[3],"tags":[],"class_list":["post-32411","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news-es"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.0 - 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