{"id":12917,"date":"2024-03-18T08:40:44","date_gmt":"2024-03-18T07:40:44","guid":{"rendered":"https:\/\/blogdelarechercheclinique.com\/?p=12917"},"modified":"2025-05-21T11:17:32","modified_gmt":"2025-05-21T09:17:32","slug":"mise-a-jour-good-clinical-practice-ich-e6-r3","status":"publish","type":"post","link":"https:\/\/blogdelarechercheclinique.com\/en\/mise-a-jour-good-clinical-practice-ich-e6-r3\/","title":{"rendered":"Mise \u00e0 jour du document Good Clinical Practice ICH E6 (R3) : Etat actuel, objectifs et principaux changements"},"content":{"rendered":"<p>En tant que professionnel et acteur dans la recherche clinique, l\u2019ARC, que ce soit ARC moniteur ou TEC, vous devez vous tenir au courant  de ces mises \u00e0 jour. Vous devez suivre une <a href=\"http:\/\/www.pharmaspecific-training.com\"><strong>formation aux Bonnes Pratiques Clinique<\/strong><\/a>s li\u00e9e \u00e0 l&rsquo;exercice de la profession. Cependant, cette pr\u00e9occupation s&rsquo;\u00e9tend \u00e9galement aux investigateurs et aux promoteurs.<\/p>\n\n\n\n<p>Bonjour, Tu es Attach\u00e9 de recherche clinique (ARC) ou Technicien d&rsquo;\u00e9tudes cliniques (TEC) ou autre acteur dans la recherche clinique&nbsp;? Aujourd\u2019hui, je vais te pr\u00e9senter la troisi\u00e8me r\u00e9vision (R3) des bonnes pratiques cliniques (BPC) de l\u2019International Council for Harmonisation (ICH GCP E6 (R3)).<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong><em>Quel est l\u2019objectif et la n\u00e9cessit\u00e9 des Bonnes Pratiques Cliniques l\u2019ICH E6 (R3)&nbsp;?<\/em><\/strong><\/h2>\n\n\n\n<p>Les <strong>Bonnes Pratiques Cliniques<\/strong> &nbsp;de l\u2019ICH E6 ont \u00e9t\u00e9 \u00e9labor\u00e9es en 1996 et la derni\u00e8re r\u00e9vision en vigueur (R2) \u00e9tait publi\u00e9e en 2016. En 19 mai 2023, les lignes directrices de l\u2019ICH E6 (R3) ont \u00e9t\u00e9 publi\u00e9es pour une consultation publique jusqu\u2019 en Octobre 2024 (Principes, Annexe 1 et 2). Sa sortie officielle est attendue au d\u00e9but de l\u2019ann\u00e9e 2025. La version R3 comprendra dans sa forme finale 3 sections&nbsp;:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Document sur les principes g\u00e9n\u00e9raux<\/li>\n\n\n\n<li>Annexe 1 : Consid\u00e9rations pour les essais interventionnels<\/li>\n\n\n\n<li>Annexe 2 : Consid\u00e9rations suppl\u00e9mentaires concernant les essais interventionnels non-traditionnels <em>(sortie de la version pr\u00e9liminaire en septembre 2024 au plus tard)<\/em><\/li>\n<\/ul>\n\n\n\n<p>Les directives de l\u2019ICH E6 sont non contraignantes et non obligatoires, et s&rsquo;adressent au<strong> essais cliniques<\/strong> interventionnels portant sur des produits exp\u00e9rimentaux.<\/p>\n\n\n<div class=\"wp-block-image\">\n<figure class=\"aligncenter size-large\"><a href=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/03\/MAJ-GCP-2.png?ssl=1\"><img data-recalc-dims=\"1\" height=\"1024\" width=\"1024\" decoding=\"async\" data-src=\"https:\/\/i0.wp.com\/blogdelarechercheclinique.com\/blog-contenu\/uploads\/2024\/03\/MAJ-GCP-2-1024x1024.png?resize=1024%2C1024&#038;ssl=1\" alt=\"les principaux changements de la version R3 des Bonnes Pratiques Cliniques de l\u2019ICH E6 par rapport \u00e0 l\u2019ancienne version\" class=\"wp-image-12941 lazyload\" src=\"data:image\/svg+xml;base64,PHN2ZyB3aWR0aD0iMSIgaGVpZ2h0PSIxIiB4bWxucz0iaHR0cDovL3d3dy53My5vcmcvMjAwMC9zdmciPjwvc3ZnPg==\" style=\"--smush-placeholder-width: 1024px; --smush-placeholder-aspect-ratio: 1024\/1024;\" \/><\/a><\/figure>\n<\/div>\n\n\n<h2 class=\"wp-block-heading\"><strong><em>Quel est l\u2019objectif et la n\u00e9cessit\u00e9 des Bonnes Pratiques Cliniques l\u2019ICH E6 (R3)&nbsp;?<\/em><\/strong><\/h2>\n\n\n\n<p>Malgr\u00e9 le d\u00e9veloppement de la <a href=\"https:\/\/database.ich.org\/sites\/default\/files\/E6_R2_Addendum.pdf\">version R2<\/a> prenant en consid\u00e9ration les technologies \u00e9mergentes et les sources de donn\u00e9es \u00e9lectroniques, elle ne parvient plus \u00e0 suivre le rythme et \u00e0 se conformer aux exigences r\u00e9glementaires des derni\u00e8res innovations en mati\u00e8re de protection des <strong>donn\u00e9es cliniques<\/strong> telles que le R\u00e8glement G\u00e9n\u00e9ral sur la Protection des Donn\u00e9es (RGPD) ou en mati\u00e8re d&rsquo;essais cliniques en g\u00e9n\u00e9ral. Tu peux acc\u00e9der \u00e0 nos vid\u00e9os concernant le RGPD et la <strong>recherche clinique <\/strong><a href=\"https:\/\/www.youtube.com\/@Blogdelarechercheclinique\/videos?view=0&amp;sort=dd&amp;shelf_id=0\">ici<\/a>.<\/p>\n\n\n\n<p>Dans son nouveau contenu, l\u2019ICH E6 (R3) vise \u00e0 r\u00e9pondre aux pr\u00e9occupations sur les \u00e9l\u00e9ments suivants :<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Syst\u00e8mes \u00e9lectroniques, donn\u00e9es, documents et int\u00e9grit\u00e9<\/li>\n\n\n\n<li>Formats d&rsquo;essais interventionnels et \u00ab interventionnels non traditionnels \u00bb<\/li>\n\n\n\n<li>Principes des BPC<\/li>\n\n\n\n<li>Consid\u00e9rations bas\u00e9es sur les risques et la qualit\u00e9 pour la protection de la s\u00e9curit\u00e9 des patients et de l&rsquo;int\u00e9grit\u00e9 des donn\u00e9es<\/li>\n\n\n\n<li>\u00c9l\u00e9ments d&rsquo;essais cliniques d\u00e9centralis\u00e9s et pragmatiques<\/li>\n<\/ul>\n\n\n\n<h2 class=\"wp-block-heading\"><strong><em>Quels sont les principaux changements de la version R3 des Bonnes Pratiques Cliniques de l\u2019ICH E6 par rapport \u00e0 l\u2019ancienne version ?<\/em><\/strong><\/h2>\n\n\n\n<p>Il convient toutefois de souligner que R3 a modifi\u00e9 et arrang\u00e9 &nbsp;le contenu de R2 plut\u00f4t que de repr\u00e9senter une refonte radicale. Toutefois, il ne s\u2019agira pas d\u2019un addendum int\u00e9gr\u00e9 comme la R2<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>a<\/strong>) <strong>Gestion de la qualit\u00e9 bas\u00e9e sur les risques<\/strong><\/h3>\n\n\n\n<p>L&rsquo;une des mises \u00e0 jour significatives est la focalisation sur le \u00ab&nbsp;Risk-Based Management Quality&nbsp;ou RBQM \u00bb (gestion de la qualit\u00e9 bas\u00e9e sur les risques). Le RBQM met l&rsquo;accent sur une approche proactive et syst\u00e9matique pour identifier, \u00e9valuer, contr\u00f4ler et communiquer les risques tout au long d\u2019un <strong><a href=\"http:\/\/www.pharmaspecific.com\/\">essai clinique<\/a><\/strong>. R3 fournit des directives plus compl\u00e8tes sur l\u2019identification, l\u2019\u00e9valuation des risques et les strat\u00e9gies d\u2019att\u00e9nuation des risques. (Conf. Annexe1 &#8211; 3.10 Quality Management)<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>b<\/strong>) <strong>Des responsabilit\u00e9s croissantes<\/strong><\/h3>\n\n\n\n<p>Concernant la responsabilit\u00e9 des \u00ab&nbsp;Comit\u00e9s de protection des personnes\/Comit\u00e9s d\u2019\u00e9thique&nbsp;\u00bb, pour la premi\u00e8re fois, il invoque l\u2019examen du consentement des mineurs participant \u00e0 un essai en tenant compte de leur \u00e2ge, de leur maturit\u00e9 et de leur \u00e9tat psychologique, ainsi que les exigences r\u00e9glementaires applicables. (Conf. Annexe1 &#8211; 1.1.7 IRB\/IEC Responsibilities)<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>c) Consentement \u00e9clair\u00e9 \u00e9largi<\/strong><\/h3>\n\n\n\n<p>Concernant la partie \u00ab&nbsp;Consentement \u00e9clair\u00e9&nbsp;\u00bb, la mise \u00e0 jour encourage \u00e9galement l&rsquo;engagement constant des participants et la mise \u00e0 disposition des r\u00e9sultats et des informations sur le traitement aux participants, afin de promouvoir la transparence de la part des promoteurs. (Conf. Annex 1 &#8211; 2.8 Informed Consent of Trial Participants)<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>d) Int\u00e9grit\u00e9 des donn\u00e9es et v\u00e9rification des donn\u00e9es sources<\/strong><\/h3>\n\n\n\n<p>L&rsquo;int\u00e9grit\u00e9 des donn\u00e9es et la cr\u00e9dibilit\u00e9 des r\u00e9sultats des essais cliniques sont d&rsquo;une importance capitale. R3 met l\u2019accent sur l\u2019utilisation de proc\u00e9dures ad\u00e9quates relatives au traitement, la <strong>protection des donn\u00e9es cliniques<\/strong> et la v\u00e9rification des donn\u00e9es sources. La r\u00e9vision actuelle expose les avantages possibles offerts par les technologies actuelles pour la collecte et manipulation de donn\u00e9es&nbsp;: acquisition de donn\u00e9es \u00e0 l\u2019aide de dossiers de sant\u00e9 \u00e9lectroniques, du cahier d&rsquo;observation \u00e9lectronique (eCRF), d\u2019appareils portables et de capteurs, aux interactions avec les patients par le biais des r\u00e9sultats rapport\u00e9s par les patients.<\/p>\n\n\n\n<p>Cependant, R3 souligne l\u2019importance cruciale de mettre en place des proc\u00e9dures solides de contr\u00f4le qualit\u00e9 sur ces technologies, comme la mise en place de la <a href=\"https:\/\/www.youtube.com\/watch?v=Ca39WZUbb_M\">validation des syst\u00e8mes informatis\u00e9s (VSI)<\/a> pour les technologies en relation avec la collecte\/g\u00e9n\u00e9ration de donn\u00e9es tout au long de la recherche pour garantir le bien-\u00eatre, la s\u00e9curit\u00e9 des participants et la fiabilit\u00e9 des donn\u00e9es. (Conf. Annex 1 &#8211; 3.16 Data and Records et 4.5 Validation of Computerised Systems) Eventuellement, l\u2019ICH E6 (R3) d\u00e9passe les exigences de l\u2019ALCOAC de l\u2019ancienne version R2 concernant l\u2019int\u00e9grit\u00e9 des donn\u00e9es et met l\u2019accent sur la n\u00e9cessit\u00e9 plus large de la fiabilit\u00e9 des donn\u00e9es et des r\u00e9sultats qui doivent \u00eatre cr\u00e9dibles et peuvent \u00eatre utilis\u00e9s pour appuyer des d\u00e9cisions \u00e9clair\u00e9es. Un nouveau paragraphe sur la \u00ab Gouvernance des donn\u00e9es&nbsp;\u00bb&nbsp;donne des indications aux investigateurs et aux promoteurs sur la mani\u00e8re de g\u00e9rer correctement l&rsquo;int\u00e9grit\u00e9, la tra\u00e7abilit\u00e9 et la s\u00e9curit\u00e9 des donn\u00e9es. (Conf. Annex 1 &#8211; 4 Data gouvernance &#8211; Investigator and Sponsor)<\/p>\n\n\n\n<p>Voil\u00e0 en ce qui concerne les principes des BPC de l\u2019ICH E6 (R3). Si tu as aim\u00e9 cet article, je te remercie de \u00ab liker \u00bb ou de partager avec tes coll\u00e8gues et amis ARC\/TEC. Tu peux \u00e9galement t&rsquo;inscrire \u00e0 la newsletter du blog pour suivre les futures mises \u00e0 jour de ce document. Et tu peux \u00e9galement nous soutenir en s\u2019abonnant \u00e0 notre page Facebook \u00ab <a href=\"https:\/\/www.facebook.com\/blogdelarechercheclinique\/?locale=fr_FR\">blog de la recherche clinique<\/a> \u00bb.<\/p>\n\n\n\n<p>\u00c0 bient\u00f4t&nbsp;! Au revoir&nbsp;!<\/p>\n\n\n\n<p>R\u00e9f\u00e9rences&nbsp;: GOOD CLINICAL PRACTICE (GCP) E6 (R3) Draft version : <a href=\"https:\/\/database.ich.org\/sites\/default\/files\/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf\">https:\/\/database.ich.org\/sites\/default\/files\/ICH_E6%28R3%29_DraftGuideline_2023_0519.pdf<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Vous devez suivre une formation aux Bonnes Pratiques Cliniques li\u00e9e \u00e0 l&rsquo;exercice de la profession. Cependant, cette pr\u00e9occupation s&rsquo;\u00e9tend \u00e9galement aux investigateurs et aux promoteurs.<\/p>","protected":false},"author":4,"featured_media":12919,"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":[450],"tags":[356,355,357],"class_list":{"0":"post-12917","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-actualites-de-la-recherche-clinique","8":"tag-bcp","9":"tag-gcp","10":"tag-ich-e6-r3"},"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":"<!-- This site is optimized with the Yoast SEO plugin v26.9 - 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