{"id":69521,"date":"2024-10-10T15:22:26","date_gmt":"2024-10-10T13:22:26","guid":{"rendered":"https:\/\/www.ipsen.com\/?page_id=69521"},"modified":"2024-10-10T15:42:30","modified_gmt":"2024-10-10T13:42:30","slug":"transparence-des-donnees-cliniques","status":"publish","type":"page","link":"https:\/\/www.ipsen.com\/fr\/transparence-des-donnees-cliniques\/","title":{"rendered":"Transparence des donn\u00e9es cliniques"},"content":{"rendered":"    <section class=\"sub-page-banner bg-img\" style=\"background-image:url(https:\/\/www.ipsen.com\/websites\/ipsen_com_v2\/wp-content\/uploads\/2023\/05\/03155810\/03-7_Sciences-Clinical-trials_Module-Banner-1.png)\">\n        <div class=\"container content-sec\">\n            <nav aria-label=\"breadcrumb\">\n            <ol class=\"breadcrumb\">\n                <li class=\"breadcrumb-item\"><a href=\"https:\/\/www.ipsen.com\/fr\/\">Accueil<\/a><\/li><li class=\"breadcrumb-item visible\"><a href=\"https:\/\/www.ipsen.com\/fr\/essais-cliniques\/\">Essais cliniques<\/a><\/li><li class=\"breadcrumb-item active\" aria-current=\"page\">Transparence des donn\u00e9es cliniques<\/li><\/ol>\n            <\/nav>            <h1 class=\"visible\">Transparence des donn\u00e9es cliniques<\/h1>\n            <p class=\"hidden\"><\/p>\n        <\/div>\n    <\/section>\n\n\n    <section class=\"title-text \">\n        <div class=\"container\">\n            <div class=\"title-text-inner\" style=\"background-color:#DBEAF5;\">\n                <!-- If heading is enabled then it's visible -->\n                <div class=\"text-head-dash hidden\">\n                                            <span class=\"dash\"><\/span> \n                        <p class=\"heading-para\">\n                                                    <\/p>\n                                        \n                <\/div>\n\n                <!-- If subtitle is enabled then it's visible -->\n                <div class=\"text-head-dash hidden\">\n                                            <h2 class=\"heading-para\">\n                                                    <\/h2>\n                    \n                <\/div>\n                \n                <!-- If description is enabled then it's visible -->\n                <div class=\"text-parbase visible\">\n                    <p><p>Ipsen s&#8217;engage dans la transparence pour la recherche clinique, en fournissant des informations facilement accessibles aux patients, aux professionnels de sant\u00e9 et aux chercheurs.\u00a0 Ipsen donne acc\u00e8s aux donn\u00e9es cliniques tout en garantissant l&#8217;anonymat des patients et la protection des informations commerciales confidentielles. Notre approche est align\u00e9e avec les <strong><a href=\"https:\/\/www.efpia.eu\/media\/qndlfduy\/phrmaefpiaprinciplesforresponsibledatasharing2023.pdf\" target=\"_blank\" rel=\"noopener\">Principes de partage responsable des donn\u00e9es d&#8217;essais cliniques (efpia.eu)<\/a><\/strong> de la Pharmaceutical Research and Manufacturers of America (PhRMA) et de la F\u00e9d\u00e9ration Europ\u00e9enne des Associations et Industries Pharmaceutiques (EFPIA), en vigueur depuis janvier 2014.<\/p>\n<\/p>\n                <\/div>\n\n                <!-- If button is enabled then it's visible -->\n                \n            <\/div>\n        <\/div>\n    <\/section>\n\n\n\n    <!--Accordion Cards Start Here-->\n    <section class=\"accordion\" data-according-id=\"790974465\">\n        <div class=\"container\">\n            <div class=\"row\">\n                <!--Accordion info section-->\n                <div class=\"column-1 col-xl-12 col-md-12 col-sm-12\">\n                    <div class=\"accordian-info\">\n                        <h2 class=\"accordian-heading visible\">Divulgation de l&#8217;\u00e9tude <\/h3>\n                        <p class=\"accordian-summary hidden\"><\/p>\n                    <\/div>\n                <\/div><!--Accordion info section over here -->\n\n                <div class=\"col-xl-12 col-lg-12 col-md-12 col-sm-12\">\n                    <div class=\"accordion accor-group\" id=\"accordionExample790974465\">\n                         \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading0\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading7909744650\" aria-expanded=\"true\" aria-controls=\"expHeading7909744650\">\n                                                Enregistrement de l&#8217;\u00e9tude                                             <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading7909744650\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading0\" data-bs-parent=\"#accordionExample790974465\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Les informations concernant les \u00e9tudes cliniques parrain\u00e9es par Ipsen sont rendues publiques au d\u00e9but de l&#8217;\u00e9tude. Les informations relatives \u00e0 l&#8217;\u00e9tude comprennent une description du plan de recherche, comme les objectifs et la conception de l&#8217;\u00e9tude clinique.<\/p>\n<p>Ces informations sont disponibles sur le registre am\u00e9ricain des essais cliniques (<strong><a href=\"https:\/\/www.clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener\">ClinicalTrials.gov<\/a><\/strong>), le registre europ\u00e9en des essais cliniques (clinicaltrialsregister.eu) ou le nouveau portail europ\u00e9en des essais cliniques (<strong><a href=\"https:\/\/www.clinicaltrialsregister.eu\/\" target=\"_blank\" rel=\"noopener\">euclinicaltrials.eu<\/a><\/strong>) et le catalogue Real Word Data (RWD) (<a href=\"https:\/\/catalogues.ema.europa.eu\/\" target=\"_blank\" rel=\"noopener\"><strong>catalogues.ema.europa.eu<\/strong><\/a>)En compl\u00e9ment de ces registres d&#8217;essais mondiaux, Ipsen assure \u00e9galement la divulgation des informations des \u00e9tudes dans divers registres ou bases de donn\u00e9es d&#8217;\u00e9tudes cliniques nationales, en conformit\u00e9 avec les r\u00e9glementations locales et les exigences l\u00e9gislatives.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                             \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading1\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading7909744651\" aria-expanded=\"true\" aria-controls=\"expHeading7909744651\">\n                                                Publication des r\u00e9sultats des \u00e9tudes                                             <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading7909744651\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading1\" data-bs-parent=\"#accordionExample790974465\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Les r\u00e9sultats des essais cliniques sponsoris\u00e9s par Ipsen sont partag\u00e9s avec le public apr\u00e8s la fin ou apr\u00e8s l\u2019arr\u00eat de l&#8217;essai. Les r\u00e9sum\u00e9s des r\u00e9sultats des essais cliniques sont g\u00e9n\u00e9ralement publi\u00e9s dans l&#8217;ann\u00e9e qui suit la fin de l&#8217;essai ou peu apr\u00e8s l&#8217;obtention de l&#8217;autorisation de mise sur le march\u00e9. Les r\u00e9sultats d&#8217;\u00e9tudes divulgu\u00e9s comprennent des r\u00e9sum\u00e9s pr\u00e9sent\u00e9s sous forme de tableaux scientifiques et\/ou des r\u00e9sum\u00e9s de rapports scientifiques d\u00e9taill\u00e9s.<\/p>\n<p>Ces r\u00e9sultats sont disponibles sur le registre am\u00e9ricain des essais cliniques (<strong><a href=\"https:\/\/www.clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener\">ClinicalTrials.gov<\/a><\/strong>), le registre europ\u00e9en des essais cliniques (<strong><a href=\"https:\/\/www.clinicaltrialsregister.eu\/\" target=\"_blank\" rel=\"noopener\">clinicaltrialsregister.eu<\/a><\/strong>) ou le nouveau portail europ\u00e9en des essais cliniques (<strong><a href=\"https:\/\/euclinicaltrials.eu\/\" target=\"_blank\" rel=\"noopener\">euclinicaltrials.eu<\/a><\/strong>) et les catalogues RWD (<strong><a href=\"https:\/\/catalogues.ema.europa.eu\/\" target=\"_blank\" rel=\"noopener\">catalogues.ema.europa.eu<\/a><\/strong>). En compl\u00e9ment de ces registres d&#8217;essais cliniques mondiaux, Ipsen assure \u00e9galement la divulgation des r\u00e9sultats des \u00e9tudes dans divers registres ou bases de donn\u00e9es d&#8217;\u00e9tudes cliniques nationales, conform\u00e9ment aux r\u00e9glementations locales et aux exigences l\u00e9gislatives.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                                                <\/div>\n                <\/div> \n            <\/div>\n        <\/div>\n    <\/section>\n    <!--Accordion Cards End Here-->\n\n\n\n    <!--Accordion Cards Start Here-->\n    <section class=\"accordion\" data-according-id=\"1386395859\">\n        <div class=\"container\">\n            <div class=\"row\">\n                <!--Accordion info section-->\n                <div class=\"column-1 col-xl-12 col-md-12 col-sm-12\">\n                    <div class=\"accordian-info\">\n                        <h2 class=\"accordian-heading visible\">Acc\u00e8s aux donn\u00e9es cliniques <\/h3>\n                        <p class=\"accordian-summary hidden\"><\/p>\n                    <\/div>\n                <\/div><!--Accordion info section over here -->\n\n                <div class=\"col-xl-12 col-lg-12 col-md-12 col-sm-12\">\n                    <div class=\"accordion accor-group\" id=\"accordionExample1386395859\">\n                         \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading0\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading13863958590\" aria-expanded=\"true\" aria-controls=\"expHeading13863958590\">\n                                                Partage des donn\u00e9es cliniques avec des chercheurs qualifi\u00e9s                                              <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading13863958590\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading0\" data-bs-parent=\"#accordionExample1386395859\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Ipsen s&#8217;engage \u00e0 partager les donn\u00e9es anonymes des \u00e9tudes cliniques telles que les donn\u00e9es individuelles des patients (IPD) et les documents de support avec des chercheurs scientifiques et m\u00e9dicaux qualifi\u00e9s qui en font la demande. Ipsen est heureux d&#8217;\u00eatre membre de la plateforme de partage de donn\u00e9es <strong><a href=\"https:\/\/vivli.org\/\" target=\"_blank\" rel=\"noopener\">www.vivli.org<\/a><\/strong>.\u00a0Les \u00e9tudes disponibles sont r\u00e9pertori\u00e9es sur cette plateforme. Ipsen mettra r\u00e9guli\u00e8rement \u00e0 jour cette liste pour y ajouter des \u00e9tudes \u00e9ligibles.\u00a0Toute demande doit \u00eatre soumise \u00e0 <strong><a href=\"https:\/\/vivli.org\/\" target=\"_blank\" rel=\"noopener\">www.vivli.org<\/a><\/strong> pour \u00e9valuation par un comit\u00e9 d&#8217;examen scientifique ind\u00e9pendant.\u00a0Les donn\u00e9es rendues anonymes seront partag\u00e9es \u00e0 disposition de chercheurs qualifi\u00e9s via la plateforme Vivli apr\u00e8s approbation de la proposition de recherche et signature d&#8217;un accord d&#8217;utilisation\/partage des donn\u00e9es.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                             \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading1\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading13863958591\" aria-expanded=\"true\" aria-controls=\"expHeading13863958591\">\n                                                Partage des donn\u00e9es cliniques avec les autorit\u00e9s r\u00e9glementaires                                             <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading13863958591\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading1\" data-bs-parent=\"#accordionExample1386395859\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Ipsen assure la divulgation en temps voulu des donn\u00e9es cliniques qui soutiennent nos demandes r\u00e9glementaires.\u00a0\u00a0Les donn\u00e9es cliniques sont fournies sur des sites Internet accessibles au public, g\u00e9r\u00e9s par l&#8217;EMA (<strong><a href=\"https:\/\/clinicaldata.ema.europa.eu\/web\/cdp\" target=\"_blank\" rel=\"noopener\">clinicaldata.ema.europa.eu<\/a><\/strong>) et par l\u2019Agence de Sant\u00e9 Canada (<strong><a href=\"https:\/\/clinical-information.canada.ca\/search\/ci-rc\" target=\"_blank\" rel=\"noopener\">clinical-information.canada.ca<\/a><\/strong>), conform\u00e9ment \u00e0 la Policy 0070 et \u00e0 la Public Release of Clinical Information (PRCI), respectivement.<\/p>\n<p>Ipsen collabore \u00e9galement avec les agences r\u00e9glementaires pour faciliter l&#8217;acc\u00e8s aux documents, qu&#8217;ils soient publi\u00e9s de mani\u00e8re proactive par l&#8217;agence ou partag\u00e9s sur demande.<\/p>\n<p>Dans tous les cas, les informations sont partag\u00e9es de fa\u00e7on \u00e0 optimiser l&#8217;utilisation des donn\u00e9es tout en pr\u00e9servant la confidentialit\u00e9 des participants \u00e0 l&#8217;\u00e9tude et du personnel.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                                                <\/div>\n                <\/div> \n            <\/div>\n        <\/div>\n    <\/section>\n    <!--Accordion Cards End Here-->\n\n\n\n    <!--Accordion Cards Start Here-->\n    <section class=\"accordion\" data-according-id=\"20616086\">\n        <div class=\"container\">\n            <div class=\"row\">\n                <!--Accordion info section-->\n                <div class=\"column-1 col-xl-12 col-md-12 col-sm-12\">\n                    <div class=\"accordian-info\">\n                        <h2 class=\"accordian-heading visible\">Communication des r\u00e9sultats de l&#8217;\u00e9tude \u00e0 la communaut\u00e9 scientifique  <\/h3>\n                        <p class=\"accordian-summary hidden\"><\/p>\n                    <\/div>\n                <\/div><!--Accordion info section over here -->\n\n                <div class=\"col-xl-12 col-lg-12 col-md-12 col-sm-12\">\n                    <div class=\"accordion accor-group\" id=\"accordionExample20616086\">\n                         \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading0\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading206160860\" aria-expanded=\"true\" aria-controls=\"expHeading206160860\">\n                                                Publications scientifiques                                             <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading206160860\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading0\" data-bs-parent=\"#accordionExample20616086\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Chez Ipsen, notre engagement envers la transparence et la responsabilit\u00e9 se manifeste par le respect des directives \u00e9thiques en mati\u00e8re de divulgation, assurant que tous les r\u00e9sultats, qu&#8217;ils soient positifs, n\u00e9gatifs ou non concluants, soient rendus public. Depuis 2019, Ipsen a pour objectif de publier ses articles dans des journaux en libre acc\u00e8s. Nous d\u00e9clarons les sources de financement, les liens institutionnels et les conflits d&#8217;int\u00e9r\u00eats potentiels afin de pr\u00e9server l&#8217;int\u00e9grit\u00e9 de nos publications.<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                                                <\/div>\n                <\/div> \n            <\/div>\n        <\/div>\n    <\/section>\n    <!--Accordion Cards End Here-->\n\n\n\n    <!--Accordion Cards Start Here-->\n    <section class=\"accordion\" data-according-id=\"1509472840\">\n        <div class=\"container\">\n            <div class=\"row\">\n                <!--Accordion info section-->\n                <div class=\"column-1 col-xl-12 col-md-12 col-sm-12\">\n                    <div class=\"accordian-info\">\n                        <h2 class=\"accordian-heading visible\">Communiquer les r\u00e9sultats des \u00e9tudes dans un langage vulgaris\u00e9<\/h3>\n                        <p class=\"accordian-summary hidden\"><\/p>\n                    <\/div>\n                <\/div><!--Accordion info section over here -->\n\n                <div class=\"col-xl-12 col-lg-12 col-md-12 col-sm-12\">\n                    <div class=\"accordion accor-group\" id=\"accordionExample1509472840\">\n                         \n                                    <!-- Accordion with Expandable panel & FAQs -->\n                                    <div class=\"accordion-item accor-item\">\n                                        <p class=\"accordion-header accor-head-para\" id=\"expHeading0\">\n                                            <button class=\"accordion-button accor-btn collapsed\" type=\"button\" data-bs-toggle=\"collapse\" data-bs-target=\"#expHeading15094728400\" aria-expanded=\"true\" aria-controls=\"expHeading15094728400\">\n                                                R\u00e9sum\u00e9s en langage vulgaris\u00e9                                            <\/button>\n                                        <\/p>\n                                        <div id=\"expHeading15094728400\" class=\"accordion-collapse collapse \" aria-labelledby=\"expHeading0\" data-bs-parent=\"#accordionExample1509472840\">\n                                            <div class=\"accordion-body\">\n                                                <div class=\"accordion-data\">\n                                                    <p><p>Ipsen s&#8217;engage \u00e0 fournir des r\u00e9sum\u00e9s simples en langage vulgaris\u00e9, incluant les r\u00e9sultats de l&#8217;\u00e9tude, conform\u00e9ment aux nouvelles exigences r\u00e9glementaires et dans le cadre d&#8217;une initiative d&#8217;Ipsen visant \u00e0 r\u00e9pondre \u00e0 la demande croissante de transparence. Ces r\u00e9sum\u00e9s ont pour objectif de rendre les informations sur les \u00e9tudes cliniques accessibles \u00e0 tous.<\/p>\n<p>Les r\u00e9sum\u00e9s sont g\u00e9n\u00e9ralement publi\u00e9s dans l&#8217;ann\u00e9e qui suit la fin de l&#8217;essai ou peu apr\u00e8s l&#8217;obtention de l&#8217;autorisation de mise sur le march\u00e9. Les r\u00e9sum\u00e9s sont accessibles sur le portail europ\u00e9en des essais cliniques (<a href=\"https:\/\/euclinicaltrials.eu\/\" target=\"_blank\" rel=\"noopener\"><strong>euclinicaltrials.eu<\/strong><\/a>), sur le site officiel d&#8217;Ipsen (<strong><a href=\"http:\/\/www.ipsen.com\" target=\"_blank\" rel=\"noopener\">Ipsen.com<\/a><\/strong>) et dans les publications des revues sponsoris\u00e9es par l&#8217;entreprise (sous r\u00e9serve des r\u00e8gles de la revue).<\/p>\n<\/p>\n                                                    <div class=\"cta-block hidden\" >\n                                                                                                            <\/div>\n                                                <\/div>\n                                            <\/div>\n                                        <\/div>\n                                    <\/div>\n                                                <\/div>\n                <\/div> \n            <\/div>\n        <\/div>\n    <\/section>\n    <!--Accordion Cards End Here-->\n\n\n\n<!--Alert Card Layout Start Here-->\n<section class=\"alertcard-section\">\n      <div class=\"container\">\n        <!--Alert Box HTML Start Here-->\n        <div class=\"alert-box warning-box\">\n                    <div class=\"info-icon\">\n              <span class=\"info-circle\"><img decoding=\"async\" src=\"https:\/\/www.ipsen.com\/wp-content\/themes\/ipsen-main\/dist\/images\/alert-warning-icon.png\" alt=\"Ic\u00f4ne d'alerte\" title=\"Ic\u00f4ne d'alerte\" \/><\/i>\n            <\/div>\n                    <div class=\"info-contents\">\n            <p class=\"info-head visible\">Remarque<\/p>\n            <p class=\"info-sub-head-para hidden\"><\/p>\n            <div class=\"alert-content visible\"><p>Une \u00e9tude clinique est toute recherche impliquant des participants humains, tandis que le terme \u00ab essai \u00bb est utilis\u00e9 pour d\u00e9signer les \u00e9tudes interventionnelles. Pour plus d&#8217;informations, consultez la page \u00ab\u00a0essais cliniques\u00a0\u00bb sur le portail des essais cliniques (euclinicaltrials.eu), le site officiel d&#8217;Ipsen (Ipsen.com) et les publications des revues sponsoris\u00e9es par l&#8217;entreprise (sous r\u00e9serve des r\u00e8gles demise \u00e0 jour).<\/p>\n<\/div>\n          <\/div>\n        <\/div>\n        <!--Alert Box HTML Start Here-->\n      <\/div>\n    <\/section>\n<!--Alert Card Layout End Here-->\n\n\n\n<div class=\"wp-block-columns is-layout-flex wp-container-core-columns-is-layout-1 wp-block-columns-is-layout-flex\">\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\" style=\"flex-basis:75px\"><\/div>\n\n\n\n<div class=\"wp-block-column is-layout-flow wp-block-column-is-layout-flow\">\n<p><\/p>\n\n\n\n<p><strong>Plus d&#8217;informations sur l&#8217;acc\u00e8s d&#8217;Ipsen aux donn\u00e9es cliniques<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"4\"><strong>Inscription aux \u00e9tudes<\/strong><\/td><\/tr><tr><td><strong>O\u00f9<\/strong><\/td><td colspan=\"2\"><strong>Quoi<\/strong><\/td><td><strong>Quand<\/strong><\/td><\/tr><tr><td>U.S. Clinical Trials Register <a href=\"https:\/\/www.clinicaltrials.gov\/\">ClinicalTrials.gov<\/a><\/td><td colspan=\"2\">\u00c9tudes interventionnelles, non interventionnelles et programmes d&#8217;acc\u00e8s \u00e9largi (au niveau produit)<\/td><td>A partir de juin 2005 &nbsp; (date de l&#8217;engagement d&#8217;Ipsen)<\/td><\/tr><tr><td>EU Clinical Trials Register <a href=\"http:\/\/www.clinicaltrialsregister.eu\/\">clinicaltrialsregister.eu<\/a> &nbsp;<\/td><td colspan=\"2\">\u00c9tudes interventionnelles men\u00e9es dans l&#8217;UE et l&#8217;Espace \u00e9conomique europ\u00e9en (EEE) chez des patients. \u00c9tudes sur des enfants r\u00e9alis\u00e9es en dehors de l&#8217;UE\/EEE, lorsque la r\u00e9glementation s&#8217;applique.<\/td><td>De mai 2004 au 30 janvier 2023<\/td><\/tr><tr><td>EU Clinical Trials Portal <a href=\"https:\/\/euclinicaltrials.eu\/\">euclinicaltrials.eu<\/a><\/td><td colspan=\"2\">\u00c9tudes interventionnelles et peu interventionnelles men\u00e9es dans l&#8217;UE\/EEE<\/td><td>\u00c0 partir du 31 janvier 2023<\/td><\/tr><tr><td>EMA RWD Catalogues <a href=\"https:\/\/catalogues.ema.europa.eu\/\">catalogues.ema.europa.eu<\/a> (Pr\u00e9c\u00e9demment Registre de s\u00e9curit\u00e9 post-autorisation (PAS) de l&#8217;UE)<\/td><td colspan=\"2\">\u00c9tudes PAS non interventionnelles (au minimum)<\/td><td>A partir de juillet 2012<\/td><\/tr><tr><td colspan=\"4\"><strong>Affichage des r\u00e9sultats<\/strong><\/td><\/tr><tr><td><strong>O\u00f9<\/strong><\/td><td><strong>Quoi<\/strong><\/td><td><strong>Comment<\/strong><\/td><td><strong>Quand<\/strong><\/td><\/tr><tr><td>U.S. Clinical Trials Register <a href=\"https:\/\/www.clinicaltrials.gov\/\">ClinicalTrials.gov<\/a><\/td><td>\u00c9tudes cliniques interventionnelles chez des patients<\/td><td>R\u00e9sum\u00e9 scientifique sous forme de tableau<\/td><td>\u00c0 partir de juin 2009, essais soumis \u00e0 la l\u00e9gislation am\u00e9ricaine FDAAA 801 &nbsp; \u00c0 partir de janvier 2014, tous les essais interventionnels chez les patients (date d&#8217;engagement d&#8217;Ipsen)<\/td><\/tr><tr><td>EU Clinical Trials Register <a href=\"http:\/\/www.clinicaltrialsregister.eu\/\">clinicaltrialsregister.eu<\/a><\/td><td>&nbsp; \u00c9tudes cliniques interventionnelles men\u00e9es aupr\u00e8s de patients dans l&#8217;UE\/EEE<\/td><td>R\u00e9sum\u00e9 scientifique sous forme de tableau<\/td><td>\u00c0 partir du 21 juillet 2015, r\u00e9sultats des \u00e9tudes achev\u00e9es entre le 21 juillet 2013 et le 30 janvier 2025 &nbsp; A partir du 21 juillet 2016 \u00e9tudes commenc\u00e9es depuis mai 2004 et achev\u00e9es avant le 21 juillet 2013<\/td><\/tr><tr><td>EU Clinical Trials Portal <a href=\"https:\/\/euclinicaltrials.eu\/\">euclinicaltrials.eu<\/a><\/td><td>\u00c9tudes cliniques interventionnelles et peu interventionnelles<\/td><td>R\u00e9sum\u00e9 scientifique sous forme de tableau &nbsp;<\/td><td>\u00c0 partir du 31 janvier 2023<\/td><\/tr><tr><td>EMA RWD Catalogues catalogues.ema.europa.eu (Formally the EU PAS Register <a href=\"https:\/\/encepp.europa.eu\/\">encepp.europa.eu<\/a>)<\/td><td>\u00c9tudes PAS non interventionnelles (au minimum)<\/td><td>R\u00e9sum\u00e9 du rapport scientifique<\/td><td>A partir de juillet 2012<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Plus d&#8217;informations sur la divulgation des \u00e9tudes d&#8217;Ipsen&nbsp;<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"3\"><strong>Avec des chercheurs qualifi\u00e9s<\/strong><\/td><\/tr><tr><td><strong>O\u00f9<\/strong><\/td><td><strong>Quoi<\/strong><\/td><td><strong>Comment<\/strong><\/td><\/tr><tr><td>Vivli <a href=\"https:\/\/vivli.org\/ourmember\/ipsen\/\">Vivli.org<\/a><\/td><td>\u00c9tudes de phase II \u00e0 IV achev\u00e9es avec un premier patient recrut\u00e9 \u00e0 partir du 1er janvier 2005. &nbsp; Inclut les produits et les indications qui sont approuv\u00e9s aux \u00c9tats-Unis et dans l&#8217;UE (aux \u00c9tats-Unis ou dans l&#8217;UE lorsque des soumissions dans les deux r\u00e9gions ne sont pas pr\u00e9vues) et pour lesquels Ipsen est le d\u00e9tenteur de l&#8217;autorisation de mise sur le march\u00e9.<\/td><td>A partir d&#8217;ao\u00fbt 2022&nbsp; &nbsp; (date d&#8217;adh\u00e9sion \u00e0 Ipsen Vivli)<\/td><\/tr><tr><td colspan=\"3\"><strong>Avec r\u00e9gulateurs<\/strong><\/td><\/tr><tr><td><strong>O\u00f9<\/strong><\/td><td><strong>Quoi<\/strong><\/td><td><strong>Quand<\/strong><\/td><\/tr><tr><td>EMA Clinical Data <a href=\"https:\/\/clinicaldata.ema.europa.eu\/web\/cdp\">clinicaldata.ema.europa.eu<\/a><\/td><td>Donn\u00e9es cliniques pour les m\u00e9dicaments \u00e0 usage humain dans l&#8217;UE<\/td><td>\u00c0 partir du 1er janvier 2015<\/td><\/tr><tr><td>Government of Canada <a href=\"https:\/\/clinical-information.canada.ca\/search\/ci-rc\">clinical-information.canada.ca<\/a><\/td><td>Informations cliniques sur les m\u00e9dicaments et les dispositifs m\u00e9dicaux au Canada<\/td><td>A partir du 20 mars 2019<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n<p><strong>Plus d&#8217;informations sur la communication des r\u00e9sultats des \u00e9tudes&nbsp;<\/strong><\/p>\n\n\n\n<figure class=\"wp-block-table\"><table class=\"has-fixed-layout\"><tbody><tr><td colspan=\"4\"><strong>Avec la communaut\u00e9 scientifique<\/strong><\/td><\/tr><tr><td><strong>O\u00f9<\/strong><\/td><td><strong>Quoi<\/strong><\/td><td><strong>Comment<\/strong><\/td><td><strong>Quand<\/strong><\/td><\/tr><tr><td>Journaux \u00e9valu\u00e9s par des pairs et\/ou pr\u00e9sentation lors de conf\u00e9rences scientifiques<\/td><td>\u00c9tudes interventionnelles et non interventionnelles, y compris les produits commercialis\u00e9s, en d\u00e9veloppement et abandonn\u00e9s<\/td><td>Manuscrit, r\u00e9sum\u00e9, poster, pr\u00e9sentation<\/td><td>Depuis ~2004 &nbsp; A partir de 2019, tous les articles de journaux en libre acc\u00e8s (date de l&#8217;engagement d&#8217;Ipsen)<\/td><\/tr><tr><td colspan=\"4\"><strong>En langage vulgaris\u00e9<\/strong><\/td><\/tr><tr><td><strong>O\u00f9<\/strong><\/td><td><strong>Quoi<\/strong><\/td><td><strong>Comment<\/strong><\/td><td><strong>Quand<\/strong><\/td><\/tr><tr><td>EU Clinical Trials Portal <a href=\"https:\/\/euclinicaltrials.eu\/\">euclinicaltrials.eu<\/a> (en anglais et dans la langue locale selon le lieu de l&#8217;\u00e9tude) et le site Internet d&#8217;Ipsen&nbsp; <a href=\"https:\/\/www.ipsen.com\/patients\/lay-summaries\/\">ipsen.com<\/a><\/td><td>\u00c9tudes cliniques interventionnelles : &nbsp; commenc\u00e9es \u00e0 partir de janvier 2022 ou commenc\u00e9es avant janvier 2022 et dont la date de fin est post\u00e9rieure \u00e0 janvier 2023.<\/td><td>R\u00e9sum\u00e9 de 4 \u00e0 8 pages<\/td><td>A partir du 31 janvier 2023 (Portail europ\u00e9en des essais cliniques) &nbsp; \u00c0 partir de mai 2023 (engagement Ipsen sur le site web de l&#8217;entreprise)<\/td><\/tr><tr><td>Parall\u00e8lement aux publications de revues parrain\u00e9es par l&#8217;entreprise (lorsque les r\u00e8gles de la revue le permettent)<\/td><td>\u00c9tudes interventionnelles et non interventionnelles.&nbsp; &nbsp; Comprend les produits commercialis\u00e9s, les produits en d\u00e9veloppement et les produits abandonn\u00e9s.<\/td><td>R\u00e9sum\u00e9 de 250 mots maximum<\/td><td>A partir de juillet 2022 en acc\u00e8s libre (date de l&#8217;engagement Ipsen)<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":11,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-69521","page","type-page","status-publish","hentry","entry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v22.5 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Transparence des donn\u00e9es cliniques - Global<\/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:\/\/www.ipsen.com\/fr\/transparence-des-donnees-cliniques\/\" \/>\n<meta property=\"og:locale\" content=\"fr_FR\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta 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