{"id":36456,"date":"1998-01-01T00:00:00","date_gmt":"1998-01-01T00:00:00","guid":{"rendered":"https:\/\/www.deberes.net\/tesis\/sin-categoria\/aspectos-metodologicos-y-estadisticos-en-el-diseno-secuencial-de-ensayos-clinicos\/"},"modified":"1998-01-01T00:00:00","modified_gmt":"1998-01-01T00:00:00","slug":"aspectos-metodologicos-y-estadisticos-en-el-diseno-secuencial-de-ensayos-clinicos","status":"publish","type":"post","link":"https:\/\/www.deberes.net\/tesis\/ciencias-medicas\/aspectos-metodologicos-y-estadisticos-en-el-diseno-secuencial-de-ensayos-clinicos\/","title":{"rendered":"Aspectos metodologicos y estadisticos en el dise\u00f1o secuencial de ensayos clinicos."},"content":{"rendered":"<h2>Tesis doctoral de <strong> Ferran Torres Benitez <\/strong><\/h2>\n<p>Introducci\u00f3n: se propuso la elaboraci\u00f3n del dise\u00f1o estad\u00edstico para un ensayo cl\u00ednico en el que se comparaba aas con triflusal en la profilaxis secundaria en los 35 d\u00edas post-infarto agudo de miocardio (iam) -triflusal en el infarto de miocardio (tim)-. Con un dise\u00f1o cl\u00e1sico se requer\u00eda un tama\u00f1o muestral (n) de 4000 pacientes para detectar una diferencia de 2,5% con protecci\u00f3n frente a los errores estad\u00edsticos de tipo i y ii de 0,05 y 0,2 respectivamente. Se realiza una revisi\u00f3n de distintos dise\u00f1os aplicables al estudio tim. Objetivos:  principales: b\u00fasqueda de un dise\u00f1o te\u00f3rico alternativo al dise\u00f1o cl\u00e1sico. Comprobaci\u00f3n del dise\u00f1o mediante simulaciones. Realizaci\u00f3n del dise\u00f1o, monitorizaci\u00f3n y an\u00e1lisis del estudio. Secundarios: revisi\u00f3n de m\u00e9todos alternativos a los dise\u00f1os cl\u00e1sicos. Estudio del ahorro en tama\u00f1o muestral de los m\u00e9todos secuenciales. Material y m\u00e9todo: se realiz\u00f3 una primera selecci\u00f3n de alternativas al dise\u00f1o cl\u00e1sico en base a la posibilidad de finalizaci\u00f3n prematura bajo la hip\u00f3tesis nula con los m\u00e9todos desarrollados en el momento del dise\u00f1o. Se simularon 10000 estudios para cada dise\u00f1o y para distintas diferencias entre tratamientos con fortran 90.  la precisi\u00f3n fue de 0,98% y de 0,78% para la estimaci\u00f3n de los errores i (alfa=0,05) y ii (beta=0,2) respectivamente. El ahorro en tama\u00f1o muestral fue estudiado con los percentiles 50 y 90 -p50(t) y p90(t)- de n y con el n\u00famero de estudios que finalizaron con n respecto a un dise\u00f1o cl\u00e1sico. Finalmente se implement\u00f3 en el estudio tim el modelo raz\u00f3n de probabilidades secuencial (rpst) truncando la regi\u00f3n de continuaci\u00f3n a 5305 pacientes. La primera inspecci\u00f3n se program\u00f3 tras 1000 inclusiones y las sucesivas cada 250, supeditadas a calendario de reuniones. Para el an\u00e1lisis de la variable principal se us\u00f3 el estimador por m\u00e1xima verosimilitud no sesgado con su intervalo de confianza (ic) al 95%, y las variab<\/p>\n<p>&nbsp;<\/p>\n<h3>Datos acad\u00e9micos de la tesis doctoral \u00ab<strong>Aspectos metodologicos y estadisticos en el dise\u00f1o secuencial de ensayos clinicos.<\/strong>\u00ab<\/h3>\n<ul>\n<li><strong>T\u00edtulo de la tesis:<\/strong>\u00a0 Aspectos metodologicos y estadisticos en el dise\u00f1o secuencial de ensayos clinicos. <\/li>\n<li><strong>Autor:<\/strong>\u00a0 Ferran Torres Benitez <\/li>\n<li><strong>Universidad:<\/strong>\u00a0 Aut\u00f3noma de barcelona<\/li>\n<li><strong>Fecha de lectura de la tesis:<\/strong>\u00a0 01\/01\/1998<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n<h3>Direcci\u00f3n y tribunal<\/h3>\n<ul>\n<li><strong>Director de la tesis<\/strong>\n<ul>\n<li>Victor Moreno Alvado<\/li>\n<\/ul>\n<\/li>\n<li><strong>Tribunal<\/strong>\n<ul>\n<li>Presidente del tribunal: Francesc Jan\u00e9 Carrenca <\/li>\n<li>Joan Sentis  Vilalta (vocal)<\/li>\n<li>Xavier Forn Dalmau (vocal)<\/li>\n<li>Francesc Xavier Carne Cladellas (vocal)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Tesis doctoral de Ferran Torres Benitez Introducci\u00f3n: se propuso la elaboraci\u00f3n del dise\u00f1o estad\u00edstico para un ensayo cl\u00ednico en el [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center 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