{"id":11974,"date":"2023-08-17T12:13:04","date_gmt":"2023-08-17T10:13:04","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=11974"},"modified":"2024-05-03T16:38:21","modified_gmt":"2024-05-03T14:38:21","slug":"reglement-essais-cliniques-phase-iv","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/reglement-essais-cliniques-phase-iv\/","title":{"rendered":"Impact du r\u00e8glement europ\u00e9en sur l&rsquo;\u00e9tude clinique phase IV"},"content":{"rendered":"<p>Vanessa Montanari a publi\u00e9 un sondage sur LinkedIn. Elle a pos\u00e9 la question suivante : \u00ab Les \u00e9tudes cliniques de phase IV de m\u00e9dicaments sont elles r\u00e9gies par le <strong>r\u00e8glement europ\u00e9en<\/strong> ou la loi Jard\u00e9 (RIPH3). <\/p>\n\n\n\n<p>Parmi 242 votants :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>33% ont r\u00e9pondu \u00ab R\u00e8glement europ\u00e9en \u00bb<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>24% ont r\u00e9pondu \u00ab Loi Jard\u00e9 RIPH3 \u00bb <\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li> 33% ont r\u00e9pondu \u00ab Ca d\u00e9pend du type de phase IV \u00bb<\/li>\n<\/ul>\n\n\n\n<ul class=\"wp-block-list\">\n<li>11% ont r\u00e9pondu \u00ab Franchement, je suis perdu \u00bb.<\/li>\n<\/ul>\n\n\n\n<p>La question se pose dans la mesure o\u00f9 le R\u00e8glement, en son article 1 pr\u00e9cise qu\u2019il ne s\u2019applique pas aux \u00e9tudes non interventionnelles<\/p>\n\n\n\n<p>R\u00e9f\u00e9rence :<\/p>\n\n\n\n<p><a href=\"https:\/\/eur-lex.europa.eu\/legal-content\/FR\/TXT\/HTML\/?uri=CELEX:32014R0536\" title=\"R\u00e8glement sur les essais clinique de m\u00e9dicaments\">R\u00e8glement sur les essais cliniques de m\u00e9dicaments<\/a> : <\/p>\n\n\n\n<h2 class=\"wp-block-heading\">1- D\u00e9finition des \u00e9tudes cliniques non interventionnelles (r\u00e9gies par la loi Jard\u00e9)<\/h2>\n\n\n\n<p>Les \u00e9tudes cliniques non interventionnelles sont d\u00e9finies par l\u2019article 2(2)\u00a74 du R\u00e8glement sur les <strong><a href=\"http:\/\/www.pharmaspecific.com\" title=\"\">essais cliniques<\/a><\/strong> de m\u00e9dicaments. Le r\u00e8glement parle comme : \u00ab une \u00e9tude clinique autre qu\u2019un essai clinique \u00bb. Ainsi, une \u00e9tude est non interventionnelle d\u00e8s lors qu\u2019elle ne remplit aucune des conditions caract\u00e9risant un essai clinique.<\/p>\n\n\n\n<p>Pour qu\u2019un essai soit donc non-interventionnel, il faut :<\/p>\n\n\n\n<ol class=\"wp-block-list\">\n<li><strong> Qu\u2019il s\u2019agisse d\u2019une investigation en rapport avec l&rsquo;homme destin\u00e9e :<\/strong><\/li>\n<\/ol>\n\n\n\n<p><strong>a.<\/strong> \u00c0 mettre en \u00e9vidence ou \u00e0 v\u00e9rifier les effets cliniques, pharmacologiques ou les autres effets pharmacodynamiques d&rsquo;un ou de plusieurs m\u00e9dicaments ;<\/p>\n\n\n\n<p><strong>b.<\/strong> \u00c0 identifier tout effet ind\u00e9sirable d&rsquo;un ou de plusieurs m\u00e9dicaments ;<\/p>\n\n\n\n<p><strong>c.<\/strong> \u00c0 \u00e9tudier l\u2019absorption, la distribution, le m\u00e9tabolisme et l\u2019excr\u00e9tion d\u2019un ou de plusieurs m\u00e9dicaments.<\/p>\n\n\n\n<p><strong> 2.   Qu\u2019aucune des conditions suivantes ne soit remplie :<\/strong><\/p>\n\n\n\n<p><strong>a.<\/strong> L&rsquo;affectation du participant \u00e0 une strat\u00e9gie th\u00e9rapeutique en particulier est fix\u00e9e \u00e0 l&rsquo;avance.  Et ne rel\u00e8ve pas de la pratique clinique normale de l&rsquo;\u00c9tat membre concern\u00e9.<\/p>\n\n\n\n<p><strong>b.<\/strong> La d\u00e9cision de prescrire les m\u00e9dicaments exp\u00e9rimentaux est prise en m\u00eame temps que la d\u00e9cision d&rsquo;int\u00e9grer le participant \u00e0 l&rsquo;essai clinique.<\/p>\n\n\n\n<p><strong>c.<\/strong> Outre la pratique clinique normale, des proc\u00e9dures de diagnostic ou de surveillance s&rsquo;appliquent aux participants.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full\"><img data-recalc-dims=\"1\" decoding=\"async\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2023\/08\/essai-clinique.png?w=1080&#038;ssl=1\" alt=\"Essais clinique de m\u00e9dicaments \u00e0 usage humain.\" class=\"wp-image-11975 lazyload\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" \/><figcaption class=\"wp-element-caption\">essai clinique des m\u00e9dicaments<\/figcaption><\/figure>\n\n\n\n<h2 class=\"wp-block-heading\">2- D\u00e9finition des essais cliniques \u00e0 faible niveau d\u2019intervention<\/h2>\n\n\n\n<p>Toutefois, le R\u00e8glement s\u2019applique aux \u00e9tudes cliniques \u00ab \u00e0 faible niveau d\u2019intervention \u00bb d\u00e9finies par l\u2019article 2(2)\u00a73 comme des \u00e9tudes remplissant l\u2019ensemble des conditions suivantes :<\/p>\n\n\n\n<p><strong>a)<\/strong> Les m\u00e9dicaments exp\u00e9rimentaux, \u00e0 l&rsquo;exclusion des placebos, sont autoris\u00e9s ;<\/p>\n\n\n\n<p><strong>b)<\/strong> Selon le protocole de l&rsquo;\u00e9tude clinique :<\/p>\n\n\n\n<p>    <strong> i)<\/strong> Les m\u00e9dicaments exp\u00e9rimentaux sont utilis\u00e9s conform\u00e9ment aux conditions de l&rsquo;autorisation de mise sur le march\u00e9 ;<\/p>\n\n\n\n<p>   <strong> ii)<\/strong> L\u2019utilisation des m\u00e9dicaments exp\u00e9rimentaux est fond\u00e9e sur des donn\u00e9es probantes et \u00e9tay\u00e9e par des publications scientifiques concernant la s\u00e9curit\u00e9 et l&rsquo;efficacit\u00e9 de ces m\u00e9dicaments exp\u00e9rimentaux dans l&rsquo;un des \u00c9tats membres concern\u00e9s;<\/p>\n\n\n\n<p><strong>c) <\/strong>Les proc\u00e9dures suppl\u00e9mentaires de diagnostic ou de surveillance impliquent au plus un risque ou une contrainte suppl\u00e9mentaire minimale pour la<a href=\"https:\/\/blogdelarechercheclinique.com\/en\/participer-essai-clinique\/\" title=\"\"> s\u00e9curit\u00e9 des participants par rapport \u00e0 la pratique clinique normale<\/a> dans tout \u00c9tat membre concern\u00e9 ;<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">3- D\u00e9finition des \u00e9tudes cliniques de phase IV<\/h2>\n\n\n\n<p>Un essai clinique de phase IV permet de suivre l\u2019utilisation du m\u00e9dicament \u00e0 long terme, dans des conditions r\u00e9elles d\u2019utilisation, afin de d\u00e9tecter des effets ind\u00e9sirables rares, des complications tardives ou encore des biais de prescription ou un mauvais usage.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\">4- R\u00e9flexion<\/h2>\n\n\n\n<p>A premi\u00e8re vue et au regard des diff\u00e9rentes d\u00e9finitions, il semblerait que l\u2019applicabilit\u00e9 du R\u00e8glement sur les essais cliniques aux \u00e9tudes de phase IV d\u00e9pende du design de l\u2019\u00e9tude et de sa r\u00e9ponse ou non aux crit\u00e8res d\u00e9finis dans les parties ci-dessus.<\/p>\n\n\n\n<p>Cette r\u00e9flexion est \u00e9tay\u00e9e par un document publi\u00e9 r\u00e9cemment par l<a href=\"https:\/\/www.ema.europa.eu\/en\/documents\/other\/annex-i-guidance-document-how-approach-protection-personal-data-commercially-confidential_.pdf\" title=\"Agence Europ\u00e9enne des m\u00e9dicaments\">\u2019Agence europ\u00e9enne des m\u00e9dicaments<\/a> qui vient classer, dans le cadre de la transparence, les essais cliniques soumis au R\u00e8glement sur les essais cliniques de m\u00e9dicaments en trois cat\u00e9gories. Or, la troisi\u00e8me cat\u00e9gorie concerne les essais cliniques \u00e0 des fins th\u00e9rapeutiques (Essai clinique int\u00e9gr\u00e9 de phase III et de phase IV, <strong>essai clinique de phase IV<\/strong>, essais cliniques \u00e0 faible niveau d\u2019intervention).<\/p>\n\n\n\n<p>L\u2019EMA pr\u00e9cise dans ce document que cette cat\u00e9gorie renvoie aux essai clinique r\u00e9alis\u00e9 \u00e0 des fins de traitement, de diagnostic ou de pr\u00e9vention chez les sujets inclus dans l&rsquo;essai clinique, \u00e0 l&rsquo;aide d&rsquo;un m\u00e9dicament exp\u00e9rimental autoris\u00e9, utilis\u00e9 conform\u00e9ment aux termes de l&rsquo;autorisation de mise sur le march\u00e9, ou l&rsquo;utilisation du m\u00e9dicament exp\u00e9rimental est fond\u00e9e sur des preuves et \u00e9tay\u00e9e par des donn\u00e9es scientifiques publi\u00e9es sur la s\u00e9curit\u00e9 et l&rsquo;efficacit\u00e9 de ce m\u00e9dicament exp\u00e9rimental dans l&rsquo;un des \u00c9tats membres concern\u00e9s.<\/p>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img data-recalc-dims=\"1\" decoding=\"async\" width=\"605\" height=\"263\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Note-to-file.jpg?resize=605%2C263&#038;ssl=1\" alt=\"Category for Trial carried\" class=\"wp-image-13571 lazyload\" style=\"--smush-placeholder-width: 605px; --smush-placeholder-aspect-ratio: 605\/263;width:839px;height:auto\" data-srcset=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Note-to-file.jpg?w=605&amp;ssl=1 605w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Note-to-file.jpg?resize=300%2C130&amp;ssl=1 300w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/Note-to-file.jpg?resize=600%2C261&amp;ssl=1 600w\" data-sizes=\"(max-width: 605px) 100vw, 605px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" \/><\/figure>\n\n\n\n<p>Ainsi, ce document confirme que certains essais de phase IV peuvent \u00eatre encadr\u00e9s par le <strong>R\u00e8glement sur les essais cliniques<\/strong> de m\u00e9dicaments.<\/p>\n\n\n\n<p> Une recherche des essais de phase IV soumis via le CTIS donne aujourd\u2019hui 63 r\u00e9sultats. Pour information, les \u00e9tudes de phase IV ne sont pas forc\u00e9ment consid\u00e9r\u00e9es comme \u00e9tudes de faible niveau d\u2019intervention. Ex&nbsp;:<\/p>\n\n\n\n<figure class=\"wp-block-image size-full is-resized\"><img data-recalc-dims=\"1\" decoding=\"async\" width=\"605\" height=\"156\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/information-essai-1.jpg?resize=605%2C156&#038;ssl=1\" alt=\"Informations relatives \u00e0 l'essai\" class=\"wp-image-13574 lazyload\" style=\"--smush-placeholder-width: 605px; --smush-placeholder-aspect-ratio: 605\/156;width:914px;height:auto\" data-srcset=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/information-essai-1.jpg?w=605&amp;ssl=1 605w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/information-essai-1.jpg?resize=300%2C77&amp;ssl=1 300w, https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/05\/information-essai-1.jpg?resize=600%2C155&amp;ssl=1 600w\" data-sizes=\"(max-width: 605px) 100vw, 605px\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" \/><\/figure>\n\n\n\n<p>Il convient donc de bien s\u2019assurer que les crit\u00e8res sont remplis.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Conclusion<\/strong><\/h2>\n\n\n\n<p>La qualification d\u2019une \u00e9tude clinique, et ainsi le dispositif juridique qui lui est applicable d\u00e9pend de la particularit\u00e9 de chaque \u00e9tude. Ainsi, une \u00e9tude de phase IV peut ou non relever du R\u00e8glement sur les essais cliniques de m\u00e9dicaments, en fonction de s\u2019il correspond \u00e0 la d\u00e9finition d\u2019un essai clinique ou d\u2019un essai clinique \u00e0 faible niveau d\u2019intervention. <\/p>\n\n\n\n<p>Pour aider l\u2019identification, la Commission europ\u00e9enne propose un arbre de d\u00e9cision afin d\u2019aider les promoteurs \u00e0 identifier si l\u2019\u00e9tude est un \u00ab&nbsp;<a href=\"https:\/\/health.ec.europa.eu\/system\/files\/2023-04\/regulation5362014_qa_en.pdf p132\" title=\"Essai clinique\">essai clinique<\/a>&nbsp;\u00bb (annexe I)). Il est propos\u00e9 d\u2019ajouter cet arbre d\u00e9cisionnel au SMQ afin de savoir facilement si une \u00e9tude r\u00e9pond au R\u00e8glement ou \u00e0 la loi Jard\u00e9.<\/p>","protected":false},"excerpt":{"rendered":"<p>Vanessa Montanari a publi\u00e9 un sondage sur LinkedIn. Elle a pos\u00e9 la question suivante : \u00ab Les \u00e9tudes de phase IV de m\u00e9dicaments sont elles r\u00e9gies par le r\u00e8glement europ\u00e9en ou la loi Jard\u00e9 (RIPH3). <\/p>","protected":false},"author":4,"featured_media":13571,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"rop_custom_images_group":[],"rop_custom_messages_group":[],"rop_publish_now":"initial","rop_publish_now_accounts":{"facebook_122143508198123560_331463380343150":""},"rop_publish_now_history":[],"rop_publish_now_status":"pending","_sitemap_exclude":false,"_sitemap_priority":"","_sitemap_frequency":"","_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"_jetpack_memberships_contains_paid_content":false,"footnotes":""},"categories":[389],"tags":[350,351,352,353,354],"class_list":{"0":"post-11974","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-reglementaires","8":"tag-nouveau-reglement-europeen-essais-cliniques","9":"tag-reglement-536-2014","10":"tag-reglement-europeen-essais-cliniques","11":"tag-reglement-sur-les-essais-cliniques","12":"tag-reglement-ue-n-536-2014"},"translation":{"provider":"WPGlobus","version":"3.0.2","language":"en","enabled_languages":["fr","en"],"languages":{"fr":{"title":true,"content":true,"excerpt":true},"en":{"title":false,"content":false,"excerpt":false}}},"yoast_head":"<!-- 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