{"id":8219,"date":"2025-05-05T16:33:24","date_gmt":"2025-05-05T08:33:24","guid":{"rendered":"https:\/\/regask.com\/?p=8219"},"modified":"2025-05-06T17:17:48","modified_gmt":"2025-05-06T09:17:48","slug":"auswirkungen-des-rollbacks-klinischer-studien","status":"publish","type":"post","link":"https:\/\/regask.com\/de\/dei-rollback-clinical-trial-impact\/","title":{"rendered":"JAMA ver\u00f6ffentlicht Analyse des R\u00fcckzugs von DE durch FDA und NIH\u2026"},"content":{"rendered":"<p class=\"\" data-start=\"388\" data-end=\"919\">An <em data-start=\"2586\" data-end=\"2665\">11. April 2025<\/em>\u00a0 Die <em data-start=\"501\" data-end=\"553\">Zeitschrift der American Medical Association (JAMA)<\/em> hat eine detaillierte Analyse ver\u00f6ffentlicht, die die m\u00f6glichen Folgen der j\u00fcngsten Ma\u00dfnahmen der US-amerikanischen Food and Drug Administration (FDA) und der National Institutes of Health (NIH) hervorhebt. Diese Beh\u00f6rden haben stillschweigend wichtige Leitlinien zu Diversit\u00e4t, Gleichberechtigung und Inklusion (DEI) von ihren Websites entfernt, was Bedenken hinsichtlich der zuk\u00fcnftigen Repr\u00e4sentation in klinischen Studien ausl\u00f6st.<\/p>\n<p class=\"\" data-start=\"921\" data-end=\"939\">Wichtige Erkenntnisse:<\/p>\n<ul data-start=\"941\" data-end=\"2020\">\n<li class=\"\" data-start=\"941\" data-end=\"1121\">\n<p class=\"\" data-start=\"943\" data-end=\"1121\"><strong data-start=\"943\" data-end=\"963\">Umkehr der Politik:<\/strong> Der R\u00fcckzug scheint mit Durchf\u00fchrungsverordnungen in Zusammenhang zu stehen, die sich gegen bundesstaatliche DEI-Initiativen richten und m\u00f6glicherweise jahrzehntelange Fortschritte in der inklusiven medizinischen Forschung gef\u00e4hrden.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1125\" data-end=\"1375\">\n<p class=\"\" data-start=\"1127\" data-end=\"1375\"><strong data-start=\"1127\" data-end=\"1149\">Auswirkungen auf die Regulierung:<\/strong> Der FDA Modernization Act von 1997 verpflichtete die Einbeziehung von Frauen und Minderheiten in klinische Studien. Die j\u00fcngste \u00c4nderung k\u00f6nnte diese Richtlinie untergraben und zu weniger repr\u00e4sentativen Sicherheits- und Wirksamkeitsdaten f\u00fcr neue Behandlungen f\u00fchren.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1377\" data-end=\"1569\">\n<p class=\"\" data-start=\"1379\" data-end=\"1569\"><strong data-start=\"1379\" data-end=\"1401\">Bedenken der Branche:<\/strong> Berichten zufolge sind Pharmaunternehmen besorgt \u00fcber politische Gegenreaktionen. Manche z\u00f6gern sogar, der Einschreibung von Menschen mit unterschiedlichem Hintergrund Priorit\u00e4t einzur\u00e4umen, weil sie bef\u00fcrchten, damit ins Visier genommen zu werden.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1571\" data-end=\"1813\">\n<p class=\"\" data-start=\"1573\" data-end=\"1813\"><strong data-start=\"1573\" data-end=\"1596\">Historische Lehren:<\/strong> Vers\u00e4umnisse in der klinischen Repr\u00e4sentation haben in der Vergangenheit zu gef\u00e4hrlichen Unterschieden in der Arzneimittelreaktion zwischen verschiedenen Rassen und ethnischen Gruppen gef\u00fchrt. Dies unterstreicht die dringende Notwendigkeit von Diversit\u00e4t in allen Phasen der klinischen Forschung.<\/p>\n<\/li>\n<li class=\"\" data-start=\"1815\" data-end=\"2020\">\n<p class=\"\" data-start=\"1817\" data-end=\"2020\"><strong data-start=\"1817\" data-end=\"1836\">Rechtliche Spannungen:<\/strong> Trotz klarer Mandate des Kongresses, wie etwa dem NIH Revitalization Act von 1993, deuten die j\u00fcngsten Verwaltungsma\u00dfnahmen darauf hin, dass die Durchsetzung dieser Diversit\u00e4tsanforderungen durch den Bund nachl\u00e4sst.<\/p>\n<\/li>\n<\/ul>\n<p>\ud83d\udc49 <em data-start=\"2586\" data-end=\"2665\">Lesen Sie den vollst\u00e4ndigen Artikel in JAMA (ver\u00f6ffentlicht am 11. April 2025), um tiefere Einblicke zu erhalten.<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>Am 11. April 2025 ver\u00f6ffentlichte das Journal of the American Medical Association (JAMA) eine detaillierte Analyse, die die potenziellen Folgen der j\u00fcngsten Ma\u00dfnahmen der US-amerikanischen Arzneimittelbeh\u00f6rde (FDA) und der National Institutes of Health (NIH) beleuchtet. Diese Beh\u00f6rden haben stillschweigend wichtige Leitlinien zu Diversit\u00e4t, Gleichstellung und Inklusion (DEI) von ihren Websites entfernt, was\u2026<\/p>","protected":false},"author":43,"featured_media":8238,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[527,35],"tags":[165,591,609],"class_list":["post-8219","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-united-states-regulations","category-pharma-biotech-latest-insights","tag-public-health","tag-clinical-trial-regulations","tag-guideline"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v28.0 (Yoast SEO v28.0) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>DEI Rollback &amp; Trials: What&#039;s at Stake? | RegASK<\/title>\n<meta name=\"description\" content=\"JAMA Analysis: FDA\/NIH quietly removed DEI guidance for clinical trials. 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