{"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":"impact-des-essais-cliniques-de-retrogradation","status":"publish","type":"post","link":"https:\/\/regask.com\/fr\/dei-rollback-clinical-trial-impact\/","title":{"rendered":"Le JAMA publie une analyse du retrait du DE par la FDA et le NIH\u2026"},"content":{"rendered":"<p class=\"\" data-start=\"388\" data-end=\"919\">Sur <em data-start=\"2586\" data-end=\"2665\">11 avril 2025<\/em>\u00a0 le <em data-start=\"501\" data-end=\"553\">Journal de l&#039;Association m\u00e9dicale am\u00e9ricaine (JAMA)<\/em> a publi\u00e9 une analyse d\u00e9taill\u00e9e soulignant les cons\u00e9quences potentielles des r\u00e9centes actions de la Food and Drug Administration (FDA) et des National Institutes of Health (NIH) des \u00c9tats-Unis. Ces agences ont discr\u00e8tement supprim\u00e9 de leurs sites web les principales directives relatives \u00e0 la diversit\u00e9, \u00e0 l&#039;\u00e9quit\u00e9 et \u00e0 l&#039;inclusion (DEI), suscitant des inqui\u00e9tudes quant \u00e0 l&#039;avenir de la repr\u00e9sentation dans les essais cliniques.<\/p>\n<p class=\"\" data-start=\"921\" data-end=\"939\">Principaux points \u00e0 retenir\u00a0:<\/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\">Renversement de politique :<\/strong> Ce recul semble li\u00e9 \u00e0 des d\u00e9crets ex\u00e9cutifs ciblant les initiatives f\u00e9d\u00e9rales en mati\u00e8re de DEI, mena\u00e7ant potentiellement des d\u00e9cennies de progr\u00e8s dans la recherche m\u00e9dicale inclusive.<\/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\">Impact r\u00e9glementaire :<\/strong> La loi de modernisation de la FDA de 1997 a rendu obligatoire l&#039;inclusion des femmes et des minorit\u00e9s dans les essais cliniques. Ce r\u00e9cent changement pourrait remettre en cause cette directive, entra\u00eenant une baisse de la repr\u00e9sentativit\u00e9 des donn\u00e9es d&#039;innocuit\u00e9 et d&#039;efficacit\u00e9 des nouveaux traitements.<\/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\">Pr\u00e9occupations de l\u2019industrie :<\/strong> Les soci\u00e9t\u00e9s pharmaceutiques seraient m\u00e9fiantes face aux r\u00e9actions politiques, certaines exprimant une h\u00e9sitation \u00e0 donner la priorit\u00e9 \u00e0 une inscription diversifi\u00e9e par crainte d&#039;attirer l&#039;attention.<\/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\">Le\u00e7ons historiques :<\/strong> Les n\u00e9gligences pass\u00e9es en mati\u00e8re de repr\u00e9sentation clinique ont entra\u00een\u00e9 de dangereuses disparit\u00e9s dans la r\u00e9ponse aux m\u00e9dicaments selon les groupes raciaux et ethniques. Cela souligne l&#039;importance cruciale de la diversit\u00e9 \u00e0 toutes les \u00e9tapes de la recherche clinique.<\/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\">Tensions juridiques :<\/strong> Malgr\u00e9 des mandats clairs du Congr\u00e8s, comme le NIH Revitalization Act de 1993, les r\u00e9centes mesures administratives sugg\u00e8rent un affaiblissement de l\u2019application f\u00e9d\u00e9rale de ces exigences en mati\u00e8re de diversit\u00e9.<\/p>\n<\/li>\n<\/ul>\n<p>\ud83d\udc49 <em data-start=\"2586\" data-end=\"2665\">Lisez l\u2019article complet dans JAMA (publi\u00e9 le 11 avril 2025) pour des informations plus approfondies.<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>On April 11, 2025\u00a0 the Journal of the American Medical Association (JAMA) has published a detailed analysis highlighting the potential consequences of recent actions by the U.S. Food and Drug Administration (FDA) and the National Institutes of Health (NIH). These agencies have quietly removed key diversity, equity, and inclusion (DEI) guidance from their websites, prompting&#8230;<\/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 v28.2) - 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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