{"id":2655,"date":"2018-06-01T16:03:04","date_gmt":"2018-06-01T14:03:04","guid":{"rendered":"https:\/\/www.rcts.fr\/uncategorized\/acces-precoce-et-donnees-de-vie-reelle-lexemple-de-lautorisation-temporaire-dutilisation-de-cohorte-atuc-daratumumab"},"modified":"2020-04-07T16:01:42","modified_gmt":"2020-04-07T14:01:42","slug":"acces-precoce-et-donnees-de-vie-reelle-lexemple-de-lautorisation-temporaire-dutilisation-de-cohorte-atuc-daratumumab","status":"publish","type":"post","link":"https:\/\/www.rcts.fr\/en\/acces-precoce-et-donnees-de-vie-reelle-lexemple-de-lautorisation-temporaire-dutilisation-de-cohorte-atuc-daratumumab\/","title":{"rendered":"Acc\u00e8s pr\u00e9coce et donn\u00e9es de vie r\u00e9elle, l\u2019exemple de l\u2019Autorisation temporaire d\u2019utilisation de cohorte (ATUc) daratumumab"},"content":{"rendered":"<p>L\u2019Autorisation temporaire d\u2019utilisation (ATU) est une proc\u00e9dure sp\u00e9cifique fran\u00e7aise d\u00e9livr\u00e9e par l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) qui permet aux patients l\u2019acc\u00e8s pr\u00e9coce \u00e0 des traitements innovants, r\u00e9pondants \u00e0 un besoin m\u00e9dical important, avant la mise sur le march\u00e9 (AMM). L\u2019ATU nominative (ATUn) est d\u00e9livr\u00e9e \u00e0 la demande et sous la responsabilit\u00e9 du m\u00e9decin prescripteur, avec un formulaire papier adress\u00e9 \u00e0 l\u2019ANSM. Demand\u00e9e par le laboratoire, l\u2019ATU de cohorte (ATUc) avec un protocole d\u2019utilisation th\u00e9rapeutique (PUT) permet d\u2019encadrer le suivi et l\u2019administration du traitement et pr\u00e9cise les donn\u00e9es \u00e0 collecter pendant la dur\u00e9e de l\u2019ATUc. Cette collecte de donn\u00e9es doit r\u00e9pondre \u00e0 deux exigences qui peuvent para\u00eetre incompatibles : d\u2019une part la surveillance \u00e9troite demand\u00e9e par l\u2019ANSM et de l\u2019autre donner l\u2019acc\u00e8s \u00e0 un traitement \u00e0 des patients en impasse th\u00e9rapeutique. L\u2019ATUc, accord\u00e9e le 08\/04\/16 par l\u2019ANSM \u00e0 Janssen pour daratumumab 20 mg\/mL, illustre parfaitement ce paradigme.<br \/>\n<a href=\"https:\/\/doi.org\/10.1016\/j.respe.2018.04.050\" rel=\"noopener noreferrer\" target=\"_blank\">Juin 2018 &#8211; Revue d&#8217;Epid\u00e9miologie et de Sant\u00e9 Publique<\/a><br \/>\nJ.Boursicot-Beuzelin, <strong>K.Mari<\/strong>, J.Thevenon, S.Vernet<\/p>\n","protected":false},"excerpt":{"rendered":"<p>L\u2019Autorisation temporaire d\u2019utilisation (ATU) est une proc\u00e9dure sp\u00e9cifique fran\u00e7aise d\u00e9livr\u00e9e par l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) qui permet aux patients l\u2019acc\u00e8s pr\u00e9coce \u00e0 des traitements innovants, r\u00e9pondants \u00e0 un besoin m\u00e9dical important, avant la mise sur le march\u00e9 (AMM). L\u2019ATU nominative (ATUn) est d\u00e9livr\u00e9e \u00e0 la demande et [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false},"categories":[56],"class_list":["post-2655","post","type-post","status-publish","format-standard","hentry","category-other"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Acc\u00e8s pr\u00e9coce et donn\u00e9es de vie r\u00e9elle, l\u2019exemple de l\u2019Autorisation temporaire d\u2019utilisation de cohorte (ATUc) daratumumab - RCTs<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"http:\/\/www.rcts.fr\/en\/acces-precoce-et-donnees-de-vie-reelle-lexemple-de-lautorisation-temporaire-dutilisation-de-cohorte-atuc-daratumumab\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Acc\u00e8s pr\u00e9coce et donn\u00e9es de vie r\u00e9elle, l\u2019exemple de l\u2019Autorisation temporaire d\u2019utilisation de cohorte (ATUc) daratumumab - RCTs\" \/>\n<meta property=\"og:description\" content=\"L\u2019Autorisation temporaire d\u2019utilisation (ATU) est une proc\u00e9dure sp\u00e9cifique fran\u00e7aise d\u00e9livr\u00e9e par l\u2019Agence nationale de s\u00e9curit\u00e9 du m\u00e9dicament et des produits de sant\u00e9 (ANSM) qui permet aux patients l\u2019acc\u00e8s pr\u00e9coce \u00e0 des traitements innovants, r\u00e9pondants \u00e0 un besoin m\u00e9dical important, avant la mise sur le march\u00e9 (AMM). 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