{"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":"durchfuhrung-klinischer-studien-mit-dezentralen-elementen","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/conducting-clinical-trials-with-decentralized-elements\/","title":{"rendered":"Durchf\u00fchrung klinischer Studien mit dezentralen Elementen"},"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>Die FDA hat die endg\u00fcltige Leitlinie der Stufe 1 (Aktenzeichen: FDA-2022-D-2870) des Zentrums f\u00fcr Arzneimittelbewertung und -forschung (CDER), des Zentrums f\u00fcr Biologika-Bewertung und -forschung (CBER), des Zentrums f\u00fcr Medizinprodukte und Strahlenschutz (CDR) und des Exzellenzzentrums f\u00fcr Onkologie (OCE) ver\u00f6ffentlicht. Diese Leitlinie enth\u00e4lt Empfehlungen f\u00fcr Sponsoren, Pr\u00fcfer und andere Beteiligte zur Integration dezentraler Elemente in klinische Studien.<\/p>","protected":false},"author":43,"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 v28.5 (Yoast SEO v28.6) - 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 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