{"id":2813,"date":"2026-03-13T13:55:06","date_gmt":"2026-03-13T12:55:06","guid":{"rendered":"https:\/\/biotechlerncenter.iph-multisite.berta-bewegt.ch\/?page_id=2813"},"modified":"2026-03-13T18:15:40","modified_gmt":"2026-03-13T17:15:40","slug":"document-de-travail","status":"publish","type":"page","link":"https:\/\/biotechlerncenter.interpharma.ch\/fr\/sujets\/genese-dun-medicament\/document-de-travail\/","title":{"rendered":"Document de travail"},"content":{"rendered":"\n<div class=\"wp-block-group has-my-grey-background-color has-background\"><div class=\"wp-block-group__inner-container is-layout-flow wp-block-group-is-layout-flow\">\n<h2 class=\"wp-block-heading\"><strong>Questions relatives \u00e0 la compr\u00e9hension du texte<\/strong><\/h2>\n\n\n\n<p>Quelles sont les diff\u00e9rentes phases des \u00e9tudes cliniques? (R\u00e9ponse: voir Graphique 4.1 \u00abLa gen\u00e8se d&rsquo;un m\u00e9dicament\u00bb)<\/p>\n\n\n\n<p>A l&rsquo;aide du graphique \u00abLa gen\u00e8se d&rsquo;un m\u00e9dicament\u00bb, faites le calcul ci-apr\u00e8s \u00e0 rebours: un m\u00e9dicament a \u00e9t\u00e9 mis sur le march\u00e9 en 2006. En quelle ann\u00e9e les essais de phase II ont-ils \u00e9t\u00e9 men\u00e9s sur ce m\u00e9dicament? Quel \u00e2ge aviez-vous \u00e0 l&rsquo;\u00e9poque? Quand la demande de brevet a-t-elle \u00e9t\u00e9 d\u00e9pos\u00e9e pour ce m\u00e9dicament et quand a-t-on commenc\u00e9 la d\u00e9termination du principe actif? Quel \u00e2ge aviez-vous \u00e0 l&rsquo;\u00e9poque?<\/p>\n\n\n\n<p>Quels sont les organismes garantissant en Suisse que les \u00e9tudes cliniques sont men\u00e9es correctement? (R\u00e9ponse:&nbsp;<a href=\"http:\/\/www.swissmedic.ch\/\" target=\"_blank\" rel=\"noreferrer noopener\">Swissmedic<\/a>, commissions cantonales d&rsquo;\u00e9thique)<\/p>\n<\/div><\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Th\u00e8me: recensement des \u00e9tudes cliniques dans un registre public<\/strong><\/h2>\n\n\n\n<p>Au cours de ces derni\u00e8res ann\u00e9es, l&rsquo;opinion publique a de plus en plus fortement r\u00e9clam\u00e9 une plus grande transparence dans les \u00e9tudes cliniques. Les entreprises pharmaceutiques se voyaient reprocher de publier les \u00e9tudes sur les m\u00e9dicaments de mani\u00e8re s\u00e9lective et d\u00e9s\u00e9quilibr\u00e9e &#8211; autrement dit d&rsquo;ignorer les r\u00e9sultats n\u00e9gatifs. En cons\u00e9quence de quoi, les associations pharmaceutiques d&rsquo;Europe, du Japon et des Etats-Unis ont d\u00e9cid\u00e9 d&rsquo;agir conjointement avec la F\u00e9d\u00e9ration internationale de l&rsquo;industrie du m\u00e9dicament (FIM) en janvier 2005: dans le but de cr\u00e9er de la transparence et de restaurer la confiance, elles se sont engag\u00e9es \u00e0 recenser d&rsquo;ici le 13 septembre 2005 toutes les \u00e9tudes cliniques en cours dans un registre accessible au public. En Suisse, les entreprises pratiquant la recherche Novartis, Roche et Serono ont satisfait dans les d\u00e9lais \u00e0 cette exigence.<\/p>\n\n\n\n<p>Les&nbsp;<a href=\"http:\/\/www.clinicaltrials.gov\/\" target=\"_blank\" rel=\"noreferrer noopener\">\u00e9tudes cliniques de Serono et de Novartis<\/a>&nbsp;(\u00e0 partir de la phase II) ainsi que&nbsp;<a href=\"http:\/\/www.roche-trials.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">les \u00e9tudes de Roche<\/a>&nbsp;peuvent \u00eatre consult\u00e9es sur l&rsquo;Internet.<\/p>\n\n\n\n<p>Combien d&rsquo;\u00e9tudes ont-elles d\u00e9j\u00e0 \u00e9t\u00e9 men\u00e9es et achev\u00e9es sur l&rsquo;Herceptin, m\u00e9dicament anticanc\u00e9reux (nom du principe actif : trastuzumab)?<\/p>\n\n\n\n<p>Combien sont actuellement planifi\u00e9s sur l&rsquo;Herceptin? (La r\u00e9ponse figure&nbsp;<a href=\"http:\/\/www.roche-trials.com\/\" target=\"_blank\" rel=\"noreferrer noopener\">ici<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Questions relatives \u00e0 la compr\u00e9hension du texte Quelles sont les diff\u00e9rentes phases des \u00e9tudes cliniques? (R\u00e9ponse: voir Graphique 4.1 \u00abLa gen\u00e8se d&rsquo;un m\u00e9dicament\u00bb) A l&rsquo;aide du graphique \u00abLa gen\u00e8se d&rsquo;un m\u00e9dicament\u00bb, faites le calcul ci-apr\u00e8s \u00e0 rebours: un m\u00e9dicament a \u00e9t\u00e9 mis sur le march\u00e9 en 2006. En quelle ann\u00e9e les essais de phase II [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":898,"menu_order":8,"comment_status":"closed","ping_status":"closed","template":"page-templates\/unterthema.php","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"class_list":["post-2813","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v27.2 (Yoast SEO v27.2) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Document de travail - biotechlerncenter<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/biotechlerncenter.interpharma.ch\/themen\/wie-ein-medikament-entsteht\/arbeitsblatt\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Document de travail\" \/>\n<meta property=\"og:description\" content=\"Questions relatives \u00e0 la compr\u00e9hension du texte Quelles sont les diff\u00e9rentes phases des \u00e9tudes cliniques? 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