{"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\/es\/for-researchers\/analyzing-data\/enrichment-in-clinical-trial-recruitment\/","title":{"rendered":"Enriquecimiento en el reclutamiento de ensayos cl\u00ednicos"},"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___69d212b855fa1\" ><a href=\"\/es\/for-researchers\/\" class=\"jkit-button-wrapper\">Para investigadores<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_69d212b856ec9\" ><a href=\"\" class=\"jkit-button-wrapper\">Herramientas<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_69d212b857d45\" ><a href=\"\/es\/for-researchers\/analyzing-data\/\" class=\"jkit-button-wrapper\">Analizando datos<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_69d212b858b9d\" ><a href=\"\" class=\"jkit-button-wrapper\">Enriquecimiento en el reclutamiento de ensayos cl\u00ednicos<\/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\">Enriquecimiento en el reclutamiento de ensayos cl\u00ednicos<\/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\">David 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>El objetivo de un ensayo cl\u00ednico es probar si un tratamiento potencial ralentiza la tasa de progresi\u00f3n de la enfermedad. La Figura 1 ilustra el rango hipot\u00e9tico de progresi\u00f3n futura en una medida de resultado entre todos los voluntarios potenciales (los valores m\u00e1s altos representan una mayor progresi\u00f3n de la enfermedad). Hacemos hincapi\u00e9 en que esta progresi\u00f3n se producir\u00e1 en el futuro y a\u00fan no se observa en el momento de la inscripci\u00f3n al ensayo.<\/p><p><strong>Figura 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>Para muchos posibles inscritos, habr\u00eda poca o ninguna progresi\u00f3n claramente medible a lo largo del ensayo, independientemente de si reciben o no el tratamiento activo del ensayo. Durante las dos visitas de este ejemplo, hay una fluctuaci\u00f3n en la tasa de cambio de cada inscrito de una visita a otra. Esta fluctuaci\u00f3n se debe en gran medida al \u201cruido\u201d dentro de la relaci\u00f3n se\u00f1al-ruido que se analiza en 'Uso de datos de observaci\u00f3n para informar el dise\u00f1o de ensayos cl\u00ednicos'. Este ruido a menudo se debe a una combinaci\u00f3n de una t\u00e9cnica de medici\u00f3n inconsistente (p. ej., cambio de m\u00e9dico\/evaluador) y una variaci\u00f3n aleatoria real del resultado d\u00eda a d\u00eda. Si, en ausencia de tratamiento, hay poca progresi\u00f3n consistente (es decir, se\u00f1al) en relaci\u00f3n con el ruido en la medici\u00f3n, entonces ser\u00e1 muy dif\u00edcil o imposible medir si el tratamiento tiene un impacto. Es importante tener en cuenta que generalmente asumimos que un tratamiento exitoso retardar\u00e1 o incluso detendr\u00e1 la progresi\u00f3n de la enfermedad, pero no conducir\u00e1 a una mejora en relaci\u00f3n con la gravedad de la enfermedad en el momento del ingreso al estudio.<\/p><p>En este ejemplo, casi toda la informaci\u00f3n sobre si un tratamiento tiene un efecto se debe a las diferencias de resultados entre el tratamiento aleatorio versus el control entre los resaltados en rojo en la Figura 2. El ensayo cl\u00ednico podr\u00eda realizarse de manera mucho m\u00e1s eficiente, con menos participantes, si Inicialmente podr\u00eda seleccionar para inscribir solo a aquellos con progresi\u00f3n roja.<\/p><p><strong>Figura 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>Por supuesto, no podemos conocer con certeza la futura progresi\u00f3n de los posibles inscritos sin tratamiento. Sin embargo, es posible que podamos predecir qu\u00e9 afiliados tienen m\u00e1s probabilidades de progresar en funci\u00f3n de sus caracter\u00edsticas actuales (factores de riesgo). <em><strong>El modelado estad\u00edstico de datos longitudinales de estudios observacionales como el Enroll-HD nos permite identificar dichas caracter\u00edsticas y estimar la magnitud de su influencia en la progresi\u00f3n futura.<\/strong><\/em><\/p><p>Los ensayos cl\u00ednicos podr\u00edan ser m\u00e1s eficientes si se utilizaran valores umbral de las caracter\u00edsticas de riesgo como criterios de inscripci\u00f3n para detectar a aquellos con alto riesgo de progresi\u00f3n mensurable (Figura 3). Esto se llama enriquecimiento de inscripci\u00f3n.<\/p><p><strong>figura 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>Debido a que no podemos predecir el futuro perfectamente, ninguna estrategia de enriquecimiento ser\u00e1 completamente efectiva para descartar a aquellos con poca progresi\u00f3n futura (todav\u00eda hay algunas l\u00edneas de progresi\u00f3n negras en la Figura 3). Sin embargo, la cantidad promedio de datos informativos aportados por inscrito ser\u00e1 mucho mayor en la muestra enriquecida.<\/p><p>Las figuras 1 a 3 representan los grupos de posibles inscritos en lugar del conjunto final de inscritos en un ensayo. El enriquecimiento conduce a un grupo m\u00e1s peque\u00f1o de posibles inscritos, pero el n\u00famero de inscritos que se deben tomar como muestra de este grupo para participar en el ensayo ser\u00e1 mucho menor que el n\u00famero requerido si no se emplea una estrategia de enriquecimiento.<\/p><p>Debemos enfatizar que la idea de enriquecimiento depende cr\u00edticamente de la suposici\u00f3n de que la gravedad de la enfermedad entre la muestra enriquecida se encuentra en un nivel apropiado para ser objetivo del mecanismo de tratamiento que se prueba en el ensayo. Esta suposici\u00f3n debe evaluarse cuidadosamente. La progresi\u00f3n r\u00e1pida sin tratamiento no tiene valor si ocurre entre personas que est\u00e1n demasiado enfermas para beneficiarse del tratamiento. Teniendo esto en cuenta, observamos que las t\u00e9cnicas descritas aqu\u00ed se pueden utilizar para seleccionar el grupo de inscripci\u00f3n m\u00e1s apropiado para un tratamiento propuesto, incluso si el grupo m\u00e1s apropiado no es el grupo con la progresi\u00f3n m\u00e1s r\u00e1pida.<\/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>Para investigadores Herramientas de an\u00e1lisis de datos Enriquecimiento en el reclutamiento de ensayos cl\u00ednicos Enriquecimiento en el reclutamiento de ensayos cl\u00ednicos Doug Langbehn El objetivo de un ensayo cl\u00ednico es probar si un tratamiento potencial ralentiza la tasa de progresi\u00f3n de la enfermedad. La Figura 1 ilustra el rango hipot\u00e9tico de progresi\u00f3n futura en una medida de resultado entre todos los voluntarios potenciales (valores m\u00e1s altos [\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\/es\/wp-json\/wp\/v2\/pages\/10233","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/enroll-hd.org\/es\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/enroll-hd.org\/es\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/enroll-hd.org\/es\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/enroll-hd.org\/es\/wp-json\/wp\/v2\/comments?post=10233"}],"version-history":[{"count":10,"href":"https:\/\/enroll-hd.org\/es\/wp-json\/wp\/v2\/pages\/10233\/revisions"}],"predecessor-version":[{"id":11174,"href":"https:\/\/enroll-hd.org\/es\/wp-json\/wp\/v2\/pages\/10233\/revisions\/11174"}],"up":[{"embeddable":true,"href":"https:\/\/enroll-hd.org\/es\/wp-json\/wp\/v2\/pages\/1419"}],"wp:attachment":[{"href":"https:\/\/enroll-hd.org\/es\/wp-json\/wp\/v2\/media?parent=10233"}],"curies":[{"name":"gracias","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}