{"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":"impacto-de-la-reversion-de-ensayos-clinicos","status":"publish","type":"post","link":"https:\/\/regask.com\/es\/dei-rollback-clinical-trial-impact\/","title":{"rendered":"JAMA publica an\u00e1lisis sobre la retirada de DE por parte de la FDA y los NIH\u2026"},"content":{"rendered":"<p class=\"\" data-start=\"388\" data-end=\"919\">En <em data-start=\"2586\" data-end=\"2665\">11 de abril de 2025<\/em>\u00a0 el <em data-start=\"501\" data-end=\"553\">Revista de la Asociaci\u00f3n M\u00e9dica Estadounidense (JAMA)<\/em> ha publicado un an\u00e1lisis detallado que destaca las posibles consecuencias de las recientes medidas de la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) y los Institutos Nacionales de Salud (NIH). Estas agencias han eliminado discretamente de sus sitios web directrices clave sobre diversidad, equidad e inclusi\u00f3n (DEI), lo que ha generado preocupaci\u00f3n sobre el futuro de la representaci\u00f3n en los ensayos cl\u00ednicos.<\/p>\n<p class=\"\" data-start=\"921\" data-end=\"939\">Conclusiones clave:<\/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\">Reversi\u00f3n de la pol\u00edtica:<\/strong> La revocaci\u00f3n parece estar vinculada a \u00f3rdenes ejecutivas dirigidas a iniciativas federales de DEI, amenazando potencialmente d\u00e9cadas de progreso en la investigaci\u00f3n m\u00e9dica inclusiva.<\/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\">Impacto regulatorio:<\/strong> La Ley de Modernizaci\u00f3n de la FDA de 1997 exigi\u00f3 la inclusi\u00f3n de mujeres y minor\u00edas en los ensayos cl\u00ednicos. El cambio reciente podr\u00eda socavar esta directiva, dando lugar a datos menos representativos sobre la seguridad y la eficacia de los nuevos tratamientos.<\/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\">Preocupaciones de la industria:<\/strong> Seg\u00fan se informa, las compa\u00f1\u00edas farmac\u00e9uticas se muestran cautelosas ante las reacciones pol\u00edticas y algunas han expresado dudas sobre priorizar la inscripci\u00f3n de personas diversas por temor a atraer escrutinio.<\/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\">Lecciones hist\u00f3ricas:<\/strong> Las omisiones pasadas en la representaci\u00f3n cl\u00ednica han generado disparidades peligrosas en la respuesta a los medicamentos entre grupos raciales y \u00e9tnicos. Esto subraya la necesidad crucial de diversidad en todas las etapas de la investigaci\u00f3n cl\u00ednica.<\/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\">Tensiones legales:<\/strong> A pesar de los mandatos claros del Congreso, como la Ley de Revitalizaci\u00f3n del NIH de 1993, las acciones administrativas recientes sugieren una aplicaci\u00f3n cada vez menor de estos requisitos de diversidad a nivel federal.<\/p>\n<\/li>\n<\/ul>\n<p>\ud83d\udc49 <em data-start=\"2586\" data-end=\"2665\">Lea el art\u00edculo completo en JAMA (publicado el 11 de abril de 2025) para obtener informaci\u00f3n m\u00e1s detallada.<\/em><\/p>","protected":false},"excerpt":{"rendered":"<p>El 11 de abril de 2025, la Revista de la Asociaci\u00f3n M\u00e9dica Estadounidense (JAMA) public\u00f3 un an\u00e1lisis detallado que destaca las posibles consecuencias de las recientes medidas de la Administraci\u00f3n de Alimentos y Medicamentos de los Estados Unidos (FDA) y los Institutos Nacionales de Salud (NIH). Estas agencias han eliminado discretamente directrices clave sobre diversidad, equidad e inclusi\u00f3n (DEI) de sus sitios web, lo que ha provocado\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 v28.4 (Yoast SEO v28.4) - 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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