{"id":7591,"date":"2024-09-25T18:21:14","date_gmt":"2024-09-25T10:21:14","guid":{"rendered":"https:\/\/regask.com\/?p=7591"},"modified":"2024-10-31T15:20:50","modified_gmt":"2024-10-31T07:20:50","slug":"realizacion-de-ensayos-clinicos-con-elementos-descentralizados","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/conducting-clinical-trials-with-decentralized-elements\/","title":{"rendered":"Realizaci\u00f3n de ensayos cl\u00ednicos con elementos descentralizados"},"content":{"rendered":"<div class=\"flex max-w-full flex-col flex-grow\">\n<div class=\"min-h-[20px] text-message flex w-full flex-col items-end gap-2 whitespace-normal break-words [.text-message+&amp;]:mt-5\" dir=\"auto\" data-message-author-role=\"assistant\" data-message-id=\"cbe8c518-724f-4161-bfd1-96e2ead478b3\">\n<div class=\"flex w-full flex-col gap-1 empty:hidden first:pt-[3px]\">\n<div class=\"markdown prose w-full break-words dark:prose-invert light\">\n<p>The FDA has issued final Level 1 guidance (Docket Number: FDA-2022-D-2870) from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Oncology Center of Excellence, offering recommendations for sponsors, investigators, and stakeholders on incorporating decentralized elements in clinical trials.<\/p>\n<p>This guidance emphasizes the advantages of conducting trial-related activities remotely, making participation more convenient for trial subjects. Decentralized elements may include telehealth consultations, in-home visits by remote trial personnel, or interactions with local healthcare providers. By allowing clinical trials to occur outside traditional sites, this approach aims to enhance participant engagement and streamline data collection.<\/p>\n<p>With this new guidance, stakeholders are encouraged to explore decentralized clinical trials to improve accessibility and efficiency in clinical research.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"mb-2 flex gap-3 empty:hidden -ml-2\">\n<div class=\"items-center justify-start rounded-xl p-1 flex\">\n<div class=\"flex items-center\">If you would like to submit comments or need assistance, please contact RegAsk.<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>La FDA ha emitido la gu\u00eda final de Nivel 1 (N\u00famero de expediente: FDA-2022-D-2870) del Centro de Evaluaci\u00f3n e Investigaci\u00f3n de Medicamentos, el Centro de Evaluaci\u00f3n e Investigaci\u00f3n de Productos Biol\u00f3gicos, el Centro de Dispositivos y Salud Radiol\u00f3gica y el Centro de Excelencia Oncol\u00f3gica, que ofrece recomendaciones a patrocinadores, investigadores y partes interesadas sobre la incorporaci\u00f3n de elementos descentralizados en los ensayos cl\u00ednicos. Esta gu\u00eda\u2026<\/p>","protected":false},"author":30,"featured_media":7601,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[35],"tags":[139,591],"class_list":["post-7591","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pharma-biotech-latest-insights","tag-decentralised-clinical-trial","tag-clinical-trial-regulations"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.3 (Yoast SEO v27.4) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Conducting Clinical Trials With Decentralized Elements | RegASK<\/title>\n<meta name=\"description\" content=\"FDA issues guidance on decentralized clinical trials to enhance participant convenience and accessibility.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" 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