{"id":276,"date":"2016-11-09T13:06:13","date_gmt":"2016-11-09T13:06:13","guid":{"rendered":"https:\/\/www.institut-myologie.org\/imotion\/?page_id=276"},"modified":"2023-03-20T14:23:23","modified_gmt":"2023-03-20T12:23:23","slug":"quest-ce-quun-essai-clinique","status":"publish","type":"page","link":"https:\/\/www.institut-myologie.org\/imotion\/quest-ce-quun-essai-clinique\/","title":{"rendered":"Qu\u2019est-ce qu\u2019un essai clinique\u00a0 ?"},"content":{"rendered":"<p>La plateforme I-Motion P\u00e9diatrique, en facilitant la r\u00e9alisation d\u2019essais chez l&rsquo;enfant dans les maladies rares, contribue \u00e0 acc\u00e9l\u00e9rer la recherche de nouveaux traitements, de nouveaux diagnostics, de nouveaux outils d\u2019\u00e9valuation clinique et de prise en charge quotidienne des patients.<\/p>\n<div class=\"entry__gallery packery row large-12\"><div class=\"col-4 entry__gallery__column\"><div class=\"entry__image column\"><div class=\"background-container\" style=\"background-image:url(https:\/\/www.institut-myologie.org\/imotion\/wp-content\/uploads\/2021\/12\/AFMTLT_201104_IMOTION_Consult_Enf_DMD_CH_049-modif.png)\"><\/div><\/div><\/div><div class=\"col-4 entry__gallery__column\"><div class=\"entry__image column\"><div class=\"background-container\" style=\"background-image:url(https:\/\/www.institut-myologie.org\/imotion\/wp-content\/uploads\/2021\/12\/AFMTLT_201027_IMOTION_Consult_Enf_DMD_CH_001-modif-1.png)\"><\/div><\/div><\/div><div class=\"col-4 entry__gallery__column\"><div class=\"entry__image column\"><div class=\"background-container\" style=\"background-image:url(https:\/\/www.institut-myologie.org\/imotion\/wp-content\/uploads\/2021\/12\/AFMTLT_201027_IMOTION_Consult_Enf_DMD_CH_018-modif.png)\"><\/div><\/div><\/div><\/div>\n<p>Un essai clinique (ou essai th\u00e9rapeutique) est une exp\u00e9rimentation scientifique au cours de laquelle un traitement potentiel\u00a0est \u00e9tudi\u00e9 chez l\u2019homme afin d\u2019\u00e9valuer sa tol\u00e9rance et son efficacit\u00e9.<\/p>\n<p>Un essai clinique a pour but de v\u00e9rifier chez un nombre significatif de personnes qu\u2019un nouveau traitement est bien tol\u00e9r\u00e9 et qu\u2019il est efficace dans la maladie que l\u2019on veut traiter. C\u2019est une \u00e9tape pr\u00e9alable incontournable \u00e0 la mise \u00e0 disposition d\u2019un nouveau traitement.<\/p>\n<ul>\n<li><a href=\"http:\/\/www.afm-telethon.fr\/essai-clinique-etape-incontournable-1755\" target=\"_blank\" rel=\"noopener noreferrer\">Lire \u00ab\u00a0L&rsquo;essai clinique : une \u00e9tape incontournable\u00a0\u00bb<\/a><\/li>\n<li>En savoir plus sur <a href=\"http:\/\/www.orpha.net\/consor\/cgi-bin\/Education_AboutOrphanDrugs.php?lng=FR&amp;stapage=ST_EDUCATION_EDUCATION_ABOUTORPHANDRUGS_CLINICALTRIALS\" target=\"_blank\" rel=\"noopener noreferrer\">les essais cliniques<\/a><\/li>\n<\/ul>\n<h3>Participer \u00e0 un essai clinique<\/h3>\n<p>Participer \u00e0 un essai clinique est un choix personnel. C\u2019est entrer dans un protocole rigoureusement d\u00e9fini tant pour assurer la s\u00e9curit\u00e9 des participants, que pour obtenir un r\u00e9sultat fiable et pertinent. C\u2019est accepter des contraintes de visites et d\u2019examens \u00e0 l\u2019h\u00f4pital suppl\u00e9mentaires.<\/p>\n<ul>\n<li>En savoir plus sur la <a href=\"http:\/\/www.afm-telethon.fr\/s-engager-dans-essai-clinique-1752\" target=\"_blank\" rel=\"noopener noreferrer\">participation \u00e0 un essai clinique<\/a><\/li>\n<\/ul>\n<h3>Les diff\u00e9rents types de visites<\/h3>\n<ul>\n<li>La visite de s\u00e9lection ou screening<\/li>\n<\/ul>\n<p>Le m\u00e9decin investigateur r\u00e9alise un examen clinique complet du patient, prend connaissance de l\u2019ensemble de son dossier m\u00e9dical et v\u00e9rifie que les crit\u00e8res d&rsquo;inclusion et d&rsquo;exclusion sont respect\u00e9s. Si un crit\u00e8re n&rsquo;est pas respect\u00e9, le patient n&rsquo;est pas \u00e9ligible pour l&rsquo;\u00e9tude et ne peut \u00eatre inclus.<\/p>\n<ul>\n<li>La visite d\u2019inclusion et la randomisation<\/li>\n<\/ul>\n<p>Le m\u00e9decin investigateur propose aux parents que leur enfant participe \u00e0 une \u00e9tude clinique si celui-ci r\u00e9pond \u00e0 priori aux crit\u00e8res de s\u00e9lection. Il leur explique et leur transmet la note d&rsquo;information. Le jour du rendez-vous il leur explique le protocole en d\u00e9tail, r\u00e9pond \u00e0 leurs questions. Si les parents acceptent de participer \u00e0 l&rsquo;\u00e9tude, le m\u00e9decin recueille alors leur consentement dat\u00e9 et sign\u00e9.<br \/>\nL&rsquo;investigateur doit ensuite notifier l&rsquo;inclusion au promoteur. Des examens compl\u00e9mentaires seront r\u00e9alis\u00e9s si n\u00e9cessaire. Quand le promoteur a valid\u00e9 l&rsquo;inclusion, il peut y avoir le cas \u00e9ch\u00e9ant pour le patient l\u2019attribution d\u2019un des traitements \u00e9tudi\u00e9s (randomisation). Les visites du patient sont alors programm\u00e9es selon le planning pr\u00e9vu par le protocole.<\/p>\n<ul>\n<li>Les visites de suivi des patients et fin d\u2019\u00e9tude<\/li>\n<\/ul>\n<p>L\u2019investigateur r\u00e9alise un examen clinique complet du patient \u00e0 chaque visite sur site, il recueille notamment tous les \u00e9v\u00e8nements ind\u00e9sirables qui ont eu lieu depuis la derni\u00e8re visite et tous les traitements pris par le patient. Les \u00e9valuations pr\u00e9vues par le protocole sont r\u00e9alis\u00e9es (\u00e9chelles motrices, questionnaires de qualit\u00e9 de vie, examens sanguins, etc.). La visite de fin d\u2019\u00e9tude se d\u00e9roule de la m\u00eame mani\u00e8re.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>La plateforme I-Motion P\u00e9diatrique, en facilitant la r\u00e9alisation d\u2019essais chez l&rsquo;enfant dans les maladies rares, contribue \u00e0 acc\u00e9l\u00e9rer la recherche de nouveaux traitements, de nouveaux diagnostics, de nouveaux outils d\u2019\u00e9valuation clinique et de prise en charge quotidienne des patients. Un essai clinique (ou essai th\u00e9rapeutique) est une exp\u00e9rimentation scientifique au cours de laquelle un traitement &hellip; <a href=\"https:\/\/www.institut-myologie.org\/imotion\/quest-ce-quun-essai-clinique\/\">Continued<\/a><\/p>\n","protected":false},"author":3,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-276","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Qu\u2019est-ce qu\u2019un essai clinique\u00a0 ? - I-Motion<\/title>\n<meta name=\"description\" content=\"En r\u00e9alisant des essais cliniques, I-Motion permet d&#039;acc\u00e9l\u00e9rer la recherche de nouveaux traitements, de nouveaux diagnostics, de nouveaux outils.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.institut-myologie.org\/imotion\/quest-ce-quun-essai-clinique\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Qu\u2019est-ce qu\u2019un essai clinique\u00a0 ? 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