{"id":25966,"date":"2026-06-03T18:32:24","date_gmt":"2026-06-03T16:32:24","guid":{"rendered":"https:\/\/lombardialifesciences.it\/?p=25966"},"modified":"2026-06-03T18:32:24","modified_gmt":"2026-06-03T16:32:24","slug":"erdera-clinical-trial-call-2026-pre-annuncio-e-date-chiave","status":"publish","type":"post","link":"https:\/\/lombardialifesciences.it\/en\/erdera-clinical-trial-call-2026-pre-annuncio-e-date-chiave\/","title":{"rendered":"ERDERA Clinical Trial Call 2026: pre-annuncio e date chiave"},"content":{"rendered":"<div class=\"[content-visibility:auto] [contain-intrinsic-size:auto_400px] pb-8 -mb-8 print:[content-visibility:visible]\">\n<div data-test-render-count=\"2\">\n<div class=\"contents\">\n<div class=\"mb-1 mt-6 group\">\n<div class=\"flex flex-col items-end gap-1\">\n<div class=\"group relative inline-flex gap-2 bg-bg-300 rounded-xl pl-2.5 py-2.5 break-words text-text-100 transition-all max-w-[75ch] flex-col !px-4 max-w-[85%]\" data-user-message-bubble=\"true\">\n<div class=\"flex flex-row gap-2 relative\"><\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"[content-visibility:auto] [contain-intrinsic-size:auto_400px] pb-8 -mb-8 print:[content-visibility:visible]\">\n<div data-test-render-count=\"1\">\n<div class=\"group\">\n<div class=\"contents\">\n<div class=\"group relative relative pb-3\" data-is-streaming=\"false\">\n<p class=\"sr-only select-none\"><span style=\"font-size: 16px;\">L&#8217;<\/span><a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" style=\"font-size: 16px;\" href=\"https:\/\/erdera.org\/\">European Rare Diseases Research Alliance (ERDERA)<\/a><span style=\"font-size: 16px;\"> ha pre-annunciato il prossimo lancio dell&#8217;<\/span><a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" style=\"font-size: 16px;\" href=\"https:\/\/erdera.org\/call\/ctc2026\/\">ERDERA Clinical Trial Call 2026<\/a><span style=\"font-size: 16px;\">, previsto per il 1\u00b0 luglio 2026. \u00c8 possibile consultare il documento di pre-annuncio <\/span><a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" style=\"font-size: 16px;\" href=\"https:\/\/erdera.org\/publications\/ctce-preannouncement2026\/\">qui<\/a><span style=\"font-size: 16px;\"> e la bozza del testo della Call <\/span><a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" style=\"font-size: 16px;\" href=\"https:\/\/erdera.org\/publications\/erdera-clinical-trial-call-2026-call-text\/\">qui<\/a><span style=\"font-size: 16px;\">.<\/span><\/p>\n<div class=\"font-claude-response relative leading-[1.65rem] [&amp;_pre&gt;div]:bg-bg-000\/50 [&amp;_pre&gt;div]:border-0.5 [&amp;_pre&gt;div]:border-border-400 [&amp;_.ignore-pre-bg&gt;div]:bg-transparent [&amp;_.standard-markdown_:is(p,blockquote,h1,h2,h3,h4,h5,h6)]:pl-2 [&amp;_.standard-markdown_:is(p,blockquote,ul,ol,h1,h2,h3,h4,h5,h6)]:pr-8 [&amp;_.progressive-markdown_:is(p,blockquote,h1,h2,h3,h4,h5,h6)]:pl-2 [&amp;_.progressive-markdown_:is(p,blockquote,ul,ol,h1,h2,h3,h4,h5,h6)]:pr-8\">\n<div class=\"standard-markdown grid-cols-1 grid [&amp;_&gt;_*]:min-w-0 gap-3 standard-markdown\">\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">L&#8217;ECTC mira a sostenere trial clinici interventistici multinazionali di Fase I, Fase I\/II e Fase II, conformi alle <a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" href=\"https:\/\/www.ema.europa.eu\/en\/ich-e6-good-clinical-practice-scientific-guideline\">Good Clinical Practice (GCP)<\/a>, nell&#8217;ambito delle malattie rare. L&#8217;obiettivo \u00e8 generare solide evidenze cliniche e, ove appropriato, dati di rilevanza regolatoria a supporto di future interazioni con le autorit\u00e0 regolatorie e del successivo sviluppo clinico.<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">La call \u00e8 concepita per affrontare le <strong>sfide specifiche dei trial clinici nelle malattie rare<\/strong>, in cui le popolazioni di pazienti sono spesso ridotte e geograficamente disperse, rendendo essenziale la collaborazione multinazionale.<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\"><strong>Ambito di applicazione e priorit\u00e0 strategiche<\/strong><\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Sono benvenute le candidature relative a tutte le malattie rare eleggibili. La call incoraggia in particolare le proposte che riguardano:<\/p>\n<ul class=\"[li_&amp;]:mb-0 [li_&amp;]:mt-1 [li_&amp;]:gap-1 [&amp;:not(:last-child)_ul]:pb-1 [&amp;:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3\">\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">Malattie rare pediatriche<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">Malattie rare a rapida progressione<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">Malattie rare prive di opzioni terapeutiche approvate o con un sostanziale bisogno medico insoddisfatto residuo nonostante i trattamenti esistenti<\/li>\n<\/ul>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Queste aree prioritarie non costituiscono criteri di eleggibilit\u00e0, ma potranno essere considerate in fase di prioritizzazione strategica qualora le proposte risultino altrimenti di qualit\u00e0 scientifica equivalente.<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\"><strong>Chi pu\u00f2 candidarsi e requisiti dei consorzi<\/strong><\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Le organizzazioni eleggibili comprendono universit\u00e0 e istituti di ricerca, ospedali e centri clinici, organizzazioni e fondazioni di ricerca non-profit, Patient Advocacy Organisations (PAO) e PMI (soggette a specifiche disposizioni di finanziamento). Ogni consorzio deve designare:<\/p>\n<ul class=\"[li_&amp;]:mb-0 [li_&amp;]:mt-1 [li_&amp;]:gap-1 [&amp;:not(:last-child)_ul]:pb-1 [&amp;:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3\">\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">un Clinical Trial Sponsor<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">un Coordinating Investigator<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">almeno un partner paziente, rappresentato da una PAO o da un altro gruppo organizzato di pazienti<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">accesso a una Clinical Trial Management Organisation (CTMO) multinazionale qualificata<\/li>\n<\/ul>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\"><strong>Interventi eleggibili<\/strong><\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Gli interventi eleggibili includono:<\/p>\n<ul class=\"[li_&amp;]:mb-0 [li_&amp;]:mt-1 [li_&amp;]:gap-1 [&amp;:not(:last-child)_ul]:pb-1 [&amp;:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3\">\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">small molecules, compresi farmaci riproposti (repurposed drugs)<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\"><a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/advanced-therapy-medicinal-products-overview\">Advanced Therapy Medicinal Products (ATMPs)<\/a> (a condizione che il processo di produzione sia stato sviluppato e validato in condizioni <a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" href=\"https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/research-development\/compliance-research-development\/good-manufacturing-practice\">GMP<\/a> appropriate per l&#8217;uso in Fase I\/II)<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">biologici e New Biological Entities (NBE)<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">biologici riproposti (repurposed biologics)<\/li>\n<\/ul>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\"><strong>Eleggibilit\u00e0 e calendario indicativo<\/strong><\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Le istituzioni dei seguenti Paesi sono attualmente previste come partner finanziabili: Austria, Belgio, Bulgaria, Canada, Cipro, Repubblica Ceca, Danimarca, Estonia, Francia, Germania, Ungheria, Irlanda, Israele, Italia, Lettonia, Lituania, Lussemburgo, Norvegia, Polonia, Portogallo, Romania, Slovacchia, Spagna, Svezia, Paesi Bassi, T\u00fcrkiye e Regno Unito.<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">In conformit\u00e0 con le disposizioni attualmente in bozza, il Clinical Trial Sponsor deve essere stabilito in uno Stato membro dell&#8217;UE o in Norvegia.<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">L&#8217;ECTC seguir\u00e0 un processo multi-fase, a partire da un&#8217;obbligatoria Stage 0 Expression of Interest (EOI). Le date chiave indicative attualmente previste sono:<\/p>\n<ul class=\"[li_&amp;]:mb-0 [li_&amp;]:mt-1 [li_&amp;]:gap-1 [&amp;:not(:last-child)_ul]:pb-1 [&amp;:not(:last-child)_ol]:pb-1 list-disc flex flex-col gap-1 pl-8 mb-3\">\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">Stage 0 \u2013 EOI (obbligatoria): 1 luglio \u2013 10 settembre 2026<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">Stage 1 \u2013 Short Proposal: 15 settembre \u2013 29 ottobre 2026<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">Stage 2 \u2013 Support Stage: gennaio \u2013 luglio 2027<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">Stage 3 \u2013 Full Proposal: luglio \u2013 settembre 2027<\/li>\n<li class=\"font-claude-response-body whitespace-normal break-words pl-2\">Decisioni di finanziamento: febbraio 2028<\/li>\n<\/ul>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\"><strong>Webinar informativo<\/strong><\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\">Un <a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" href=\"https:\/\/erdera.org\/event\/erdera-clinical-trial-call-2026-information-webinar\/\">webinar informativo<\/a> per i potenziali candidati si terr\u00e0 il 6 luglio 2026 (15:00\u201317:00 CEST) e fornir\u00e0 una panoramica degli obiettivi della call, dei requisiti di eleggibilit\u00e0, del processo di valutazione e del calendario indicativo. Ulteriori informazioni e registrazione <a class=\"underline underline underline-offset-2 decoration-1 decoration-current\/40 hover:decoration-current focus:decoration-current\" href=\"https:\/\/erdera.org\/?post_type=tribe_events&amp;p=15927\">qui<\/a>.<\/p>\n<p class=\"font-claude-response-body break-words whitespace-normal leading-[1.7]\"><a href=\"https:\/\/erdera.org\/news\/erdera-clinical-trial-call-2026-pre-announcement-and-key-dates\/\" target=\"_blank\" rel=\"noopener\">Clicca qui<\/a> per maggiori informazioni.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>L&#8217;European Rare Diseases Research Alliance (ERDERA) ha pre-annunciato il prossimo lancio dell&#038;&#8230;<\/p>\n","protected":false},"author":4,"featured_media":20898,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"inline_featured_image":false,"footnotes":""},"categories":[2,44],"tags":[],"class_list":["post-25966","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-articles","category-news"],"acf":[],"_links":{"self":[{"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/posts\/25966","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/comments?post=25966"}],"version-history":[{"count":1,"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/posts\/25966\/revisions"}],"predecessor-version":[{"id":25967,"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/posts\/25966\/revisions\/25967"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/media\/20898"}],"wp:attachment":[{"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/media?parent=25966"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/categories?post=25966"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/lombardialifesciences.it\/en\/wp-json\/wp\/v2\/tags?post=25966"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}