{"id":2511,"date":"2020-01-03T18:07:24","date_gmt":"2020-01-03T17:07:24","guid":{"rendered":"https:\/\/www.rcts.fr\/uncategorized\/acces-precoce-et-donnees-de-vie-reelle-lexemple-de-latu-de-cohorte-daratumumab"},"modified":"2026-01-26T11:22:03","modified_gmt":"2026-01-26T10:22:03","slug":"early-real-world-data-daratumumab","status":"publish","type":"post","link":"https:\/\/www.rcts.fr\/en\/early-real-world-data-daratumumab\/","title":{"rendered":"Early access and real word data: the example of the DARATUMUMAB cohort ATU"},"content":{"rendered":"

L\u2019Autorisation Temporaire d\u2019Utilisation est une proc\u00e9dure sp\u00e9cifique fran\u00e7aise d\u00e9livr\u00e9e par l\u2019ANSM qui permet aux patients l\u2019acc\u00e8s pr\u00e9coce \u00e0 des traitements innovants, r\u00e9pondant \u00e0 un besoin m\u00e9dical important, avant la mise sur le march\u00e9. Demand\u00e9e par le laboratoire, l\u2019ATU de cohorte avec un protocole d\u2019utilisation th\u00e9rapeutique permet d\u2019encadrer le suivi et l\u2019administration du traitement et pr\u00e9cise les donn\u00e9es \u00e0 collecter.
\nRCTs a ainsi accompagn\u00e9 le laboratoire Janssen-Cilag dans l\u2019analyse des donn\u00e9es collect\u00e9e dans le cadre de l\u2019ATU de cohorte obtenue pour daratumumab, dans le traitement du my\u00e9lome multiple.
\nDeux rapports, \u00e0 destination de l\u2019ANSM et r\u00e9pondant \u00e0 des exigences pr\u00e9cises, ont \u00e9t\u00e9 r\u00e9dig\u00e9s pour pr\u00e9senter les donn\u00e9es cliniques, d\u2019efficacit\u00e9 et de tol\u00e9rance des 180 patients inclus dans l\u2019ATU entre le 9 mai et le 20 juin 2016 et suivis jusqu\u2019au 7 juillet 2016.
\nPublication<\/a>
\nATU DARA Poster AFCROs 2018<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

L\u2019Autorisation Temporaire d\u2019Utilisation est une proc\u00e9dure sp\u00e9cifique fran\u00e7aise d\u00e9livr\u00e9e par l\u2019ANSM qui permet aux patients l\u2019acc\u00e8s pr\u00e9coce \u00e0 des traitements innovants, r\u00e9pondant \u00e0 un besoin m\u00e9dical important, avant la mise sur le march\u00e9. Demand\u00e9e par le laboratoire, l\u2019ATU de cohorte avec un protocole d\u2019utilisation th\u00e9rapeutique permet d\u2019encadrer le suivi et l\u2019administration du traitement et pr\u00e9cise […]<\/p>\n","protected":false},"author":2,"featured_media":2237,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false},"categories":[47],"class_list":["post-2511","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-success-stories-en"],"acf":[],"yoast_head":"\nEarly real\u2011world data access for Daratumumab<\/title>\n<meta name=\"description\" content=\"Explore early real\u2011world data for Daratumumab: an illustration of innovative frameworks designed to accelerate patient access to therapies.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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