{"id":10233,"date":"2021-11-17T09:30:04","date_gmt":"2021-11-17T14:30:04","guid":{"rendered":"https:\/\/platform.enroll-hd.org\/?page_id=10233"},"modified":"2021-12-08T11:56:15","modified_gmt":"2021-12-08T16:56:15","slug":"enrichment-in-clinical-trial-recruitment","status":"publish","type":"page","link":"https:\/\/enroll-hd.org\/fr\/for-researchers\/analyzing-data\/enrichment-in-clinical-trial-recruitment\/","title":{"rendered":"Enrichissement dans le recrutement d&#039;essais cliniques"},"content":{"rendered":"<style>.elementor-10233 .elementor-element.elementor-element-c43db38 .jeg-elementor-kit.jkit-button{text-align:center;}.elementor-10233 .elementor-element.elementor-element-c43db38 .jeg-elementor-kit.jkit-button .jkit-button-wrapper{padding:0px 0px 0px 0px;font-family:var( --e-global-typography-6cb29b0-font-family ), Sans-serif;font-size:var( --e-global-typography-6cb29b0-font-size );font-weight:var( --e-global-typography-6cb29b0-font-weight );line-height:var( 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.jeg-elementor-kit.jkit-button.icon-position-before .jkit-button-wrapper svg{margin-right:10px;}.elementor-10233 .elementor-element.elementor-element-e6cd407 .jeg-elementor-kit.jkit-button.icon-position-after .jkit-button-wrapper i, .elementor-10233 .elementor-element.elementor-element-e6cd407 .jeg-elementor-kit.jkit-button.icon-position-after .jkit-button-wrapper svg{margin-left:10px;}.elementor-10233 .elementor-element.elementor-element-7a93c61 .elementor-heading-title{font-size:16px;}}<\/style>\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"10233\" class=\"elementor elementor-10233\" data-elementor-post-type=\"page\">\n\t\t\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-0959aa5 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"0959aa5\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-4362823\" data-id=\"4362823\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-c43db38 elementor-widget__width-auto elementor-widget elementor-widget-jkit_button\" data-id=\"c43db38\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"jkit_button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div  class=\"jeg-elementor-kit jkit-button  icon-position-after jeg_module___69d26973afeb9\" ><a href=\"\/fr\/for-researchers\/\" class=\"jkit-button-wrapper\">Pour les chercheurs<i aria-hidden=\"true\" class=\"fas fa-chevron-right\"><\/i><\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-c9eec4e elementor-widget__width-auto elementor-widget elementor-widget-jkit_button\" data-id=\"c9eec4e\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"jkit_button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div  class=\"jeg-elementor-kit jkit-button  icon-position-after jeg_module__1_69d26973b0dca\" ><a href=\"\" class=\"jkit-button-wrapper\">Outils<i aria-hidden=\"true\" class=\"fas fa-chevron-right\"><\/i><\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-ae4e7dc elementor-widget__width-auto elementor-widget elementor-widget-jkit_button\" data-id=\"ae4e7dc\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"jkit_button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div  class=\"jeg-elementor-kit jkit-button  icon-position-after jeg_module__2_69d26973b1c17\" ><a href=\"\/fr\/for-researchers\/analyzing-data\/\" class=\"jkit-button-wrapper\">Analyser les donn\u00e9es<i aria-hidden=\"true\" class=\"fas fa-chevron-right\"><\/i><\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-e6cd407 elementor-widget__width-auto elementor-widget elementor-widget-jkit_button\" data-id=\"e6cd407\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"jkit_button.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<div  class=\"jeg-elementor-kit jkit-button  icon-position-after jeg_module__3_69d26973b2a40\" ><a href=\"\" class=\"jkit-button-wrapper\">Enrichissement dans le recrutement d&#039;essais cliniques<\/a><\/div>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<section class=\"elementor-section elementor-top-section elementor-element elementor-element-d799ba4 elementor-section-boxed elementor-section-height-default elementor-section-height-default\" data-id=\"d799ba4\" data-element_type=\"section\" data-e-type=\"section\">\n\t\t\t\t\t\t<div class=\"elementor-container elementor-column-gap-default\">\n\t\t\t\t\t<div class=\"elementor-column elementor-col-100 elementor-top-column elementor-element elementor-element-18a6d3d\" data-id=\"18a6d3d\" data-element_type=\"column\" data-e-type=\"column\">\n\t\t\t<div class=\"elementor-widget-wrap elementor-element-populated\">\n\t\t\t\t\t\t<div class=\"elementor-element elementor-element-6b9acd4 elementor-widget elementor-widget-heading\" data-id=\"6b9acd4\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h2 class=\"elementor-heading-title elementor-size-default\">Enrichissement dans le recrutement d&#039;essais cliniques<\/h2>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-7a93c61 elementor-widget elementor-widget-heading\" data-id=\"7a93c61\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"heading.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t<h5 class=\"elementor-heading-title elementor-size-default\">Doug Langbehn<\/h5>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<div class=\"elementor-element elementor-element-b673a94 elementor-widget elementor-widget-text-editor\" data-id=\"b673a94\" data-element_type=\"widget\" data-e-type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p>L\u2019objectif d\u2019un essai clinique est de tester si un traitement potentiel ralentit la progression de la maladie. La figure 1 illustre la plage hypoth\u00e9tique de progression future dans une mesure de r\u00e9sultat parmi tous les volontaires potentiels (des valeurs plus \u00e9lev\u00e9es repr\u00e9sentent une plus grande progression de la maladie). Nous soulignons que cette progression se produit dans le futur et n'est pas encore observ\u00e9e au moment de l'inclusion dans l'essai.<\/p><p><strong>Figure 1<\/strong><\/p><p><a href=\"http:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-1.png\"><img fetchpriority=\"high\" decoding=\"async\" class=\"alignnone wp-image-10235 size-full\" src=\"http:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-1.png\" alt=\"\" width=\"482\" height=\"402\" srcset=\"https:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-1.png 482w, https:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-1-300x250.png 300w\" sizes=\"(max-width: 482px) 100vw, 482px\" \/><\/a><\/p><p>Pour de nombreux participants potentiels, il y aurait peu ou pas de progression clairement mesurable au cours de l'essai, qu'ils re\u00e7oivent ou non le traitement actif de l'essai. Au cours des deux visites de cet exemple, il y a une fluctuation du taux de changement de chaque participant d'une visite \u00e0 l'autre. Cette fluctuation est en grande partie due au \u00ab bruit \u00bb dans le rapport signal\/bruit \u00e9voqu\u00e9 dans \u00ab Utilisation des donn\u00e9es d'observation pour \u00e9clairer la conception des essais cliniques \u00bb. Ce bruit est souvent d\u00fb \u00e0 une combinaison de techniques de mesure incoh\u00e9rentes (par exemple, changement de clinicien\/\u00e9valuateur) et de variations quotidiennes r\u00e9elles al\u00e9atoires des r\u00e9sultats. Si, en l'absence de traitement, il y a peu de progression constante (c'est-\u00e0-dire de signal) par rapport au bruit dans la mesure, il sera alors tr\u00e8s difficile, voire impossible, de mesurer si le traitement a un impact. Il est important de noter que nous supposons g\u00e9n\u00e9ralement qu'un traitement r\u00e9ussi ralentira, voire arr\u00eatera la progression de la maladie, mais n'entra\u00eenera pas d'am\u00e9lioration par rapport \u00e0 la gravit\u00e9 de la maladie au moment de l'entr\u00e9e dans l'\u00e9tude.<\/p><p>Dans cet exemple, presque toutes les informations indiquant si un traitement a un effet sont dues aux diff\u00e9rences de r\u00e9sultats entre le traitement randomis\u00e9 et le contr\u00f4le parmi ceux surlign\u00e9s en rouge dans la figure 2. L'essai clinique pourrait \u00eatre r\u00e9alis\u00e9 beaucoup plus efficacement, avec moins de participants, si nous pouvions initialement screener pour inclure uniquement ceux avec une progression rouge.<\/p><p><strong>Figure 2<\/strong><\/p><p><a href=\"http:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-2.png\"><img decoding=\"async\" class=\"alignnone wp-image-10236 size-full\" src=\"http:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-2.png\" alt=\"\" width=\"468\" height=\"390\" srcset=\"https:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-2.png 468w, https:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-2-300x250.png 300w\" sizes=\"(max-width: 468px) 100vw, 468px\" \/><\/a><\/p><p>Nous ne pouvons bien s\u00fbr pas conna\u00eetre avec certitude la future progression des participants potentiels non trait\u00e9s. Cependant, nous pourrons peut-\u00eatre pr\u00e9dire quels participants sont les plus susceptibles de progresser en fonction de leurs caract\u00e9ristiques actuelles (facteurs de risque). <em><strong>La mod\u00e9lisation statistique des donn\u00e9es longitudinales issues d&#039;\u00e9tudes observationnelles telles que Enroll-HD nous permet d&#039;identifier ces caract\u00e9ristiques et d&#039;estimer l&#039;ampleur de leur influence sur la progression future.<\/strong><\/em><\/p><p>Les essais cliniques pourraient \u00eatre rendus plus efficaces si les valeurs seuils des caract\u00e9ristiques de risque \u00e9taient utilis\u00e9es comme crit\u00e8res d'inclusion pour screener les personnes pr\u00e9sentant un risque \u00e9lev\u00e9 de progression mesurable (Figure 3). C\u2019est ce qu\u2019on appelle l\u2019enrichissement des inclusions.<\/p><p><strong>figure 3<\/strong><\/p><p><a href=\"http:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-3.png\"><img decoding=\"async\" class=\"alignnone wp-image-10237 size-full\" src=\"http:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-3.png\" alt=\"\" width=\"468\" height=\"390\" srcset=\"https:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-3.png 468w, https:\/\/enroll-hd.org\/wp-content\/uploads\/2021\/11\/enrichment-in-ctr-3-300x250.png 300w\" sizes=\"(max-width: 468px) 100vw, 468px\" \/><\/a><\/p><p>Parce que nous ne pouvons pas pr\u00e9dire parfaitement l\u2019avenir, aucune strat\u00e9gie d\u2019enrichissement ne sera compl\u00e8tement efficace pour \u00e9liminer ceux dont la progression future est faible (il y a encore quelques lignes de progression noires dans la figure 3). Cependant, la quantit\u00e9 moyenne de donn\u00e9es informatives fournies par participant sera beaucoup plus \u00e9lev\u00e9e dans l\u2019\u00e9chantillon enrichi.<\/p><p>Les figures 1 \u00e0 3 repr\u00e9sentent les groupes de participants potentiels plut\u00f4t que l'ensemble final de participants \u00e0 un essai. L'enrichissement conduit \u00e0 un plus petit bassin de participants potentiels, mais le nombre de participants qui doivent \u00eatre \u00e9chantillonn\u00e9s dans ce pool pour participer \u00e0 l'essai sera beaucoup plus petit que le nombre requis si aucune strat\u00e9gie d'enrichissement n'est utilis\u00e9e.<\/p><p>Nous devons souligner que l'id\u00e9e d'enrichissement d\u00e9pend essentiellement de l'hypoth\u00e8se selon laquelle la gravit\u00e9 de la maladie au sein de l'\u00e9chantillon enrichi est \u00e0 un niveau appropri\u00e9 pour \u00eatre cibl\u00e9e par le m\u00e9canisme du traitement test\u00e9 dans l'essai. Cette hypoth\u00e8se doit \u00eatre \u00e9valu\u00e9e avec soin. Une progression rapide sans traitement n\u2019a aucune valeur si elle survient chez des personnes trop malades pour b\u00e9n\u00e9ficier du traitement. Dans cet esprit, nous notons que les techniques d\u00e9crites ici peuvent \u00eatre utilis\u00e9es pour s\u00e9lectionner le groupe d'inclus le plus appropri\u00e9 pour un traitement propos\u00e9, m\u00eame si le groupe le plus appropri\u00e9 n'est pas celui ayant la progression la plus rapide.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"<p>Pour les chercheurs Outils Analyser l&#039;enrichissement des donn\u00e9es dans le recrutement pour les essais cliniques Enrichissement dans le recrutement pour les essais cliniques Doug Langbehn L&#039;objectif d&#039;un essai clinique est de tester si un traitement potentiel ralentit le taux de progression de la maladie. La figure 1 illustre la plage hypoth\u00e9tique de progression future dans une mesure de r\u00e9sultat parmi tous les volontaires potentiels (valeurs plus \u00e9lev\u00e9es [\u2026]<\/p>","protected":false},"author":1,"featured_media":0,"parent":1419,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"class_list":["post-10233","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/pages\/10233","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/comments?post=10233"}],"version-history":[{"count":10,"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/pages\/10233\/revisions"}],"predecessor-version":[{"id":11174,"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/pages\/10233\/revisions\/11174"}],"up":[{"embeddable":true,"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/pages\/1419"}],"wp:attachment":[{"href":"https:\/\/enroll-hd.org\/fr\/wp-json\/wp\/v2\/media?parent=10233"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}