{"id":37611,"date":"2025-02-24T10:06:39","date_gmt":"2025-02-24T09:06:39","guid":{"rendered":"https:\/\/faus-moliner.com\/retos-y-oportunidades-del-real-world-data\/"},"modified":"2025-02-24T10:12:16","modified_gmt":"2025-02-24T09:12:16","slug":"retos-y-oportunidades-del-real-world-data","status":"publish","type":"post","link":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/","title":{"rendered":"Retos y oportunidades del Real World Data"},"content":{"rendered":"\n

\u201cExcellence of clinical evidence is the heart of every well-informed decision on the development, authorization, reimbursement, use and monitoring of medicines\u201d<\/em>. Con esta frase empieza el art\u00edculo \u201cClinical Evidence 2030\u201d<\/em> recientemente publicado en la revista de la American Society for Clinical Pharmacology and Therapeutics<\/em>. El art\u00edculo lo firman algunos de los representantes de las principales agencias nacionales del medicamento, as\u00ed como de la EMA. Un disclaimer nos advierte que las opiniones expresadas en el art\u00edculo son exclusivamente de los autores y no deben entenderse como realizadas en nombre o como reflejo de la posici\u00f3n de las agencias reguladoras a las que est\u00e1n vinculados. Pese a esta advertencia, creo que su visi\u00f3n s\u00ed nos puede servir para tener algunas orientaciones valiosas de hacia d\u00f3nde se encaminar\u00e1 en los pr\u00f3ximos a\u00f1os la generaci\u00f3n de la evidencia cl\u00ednica en el \u00e1mbito del medicamento en la UE.<\/p>\n\n\n\n

En este interesante documento se identifican hasta seis principios rectores que, a juicio de los autores, ayudar\u00e1n a alcanzar la excelencia en la generaci\u00f3n de esta evidencia cl\u00ednica. De entre todos ellos yo destacar\u00eda los dos aspectos siguientes. Primero, el papel central que deben tener los pacientes en la generaci\u00f3n de evidencia cl\u00ednica. Los pacientes aportan su experiencia personal y conocimientos tanto sobre las enfermedades y las opciones de tratamiento como sobre el impacto que las decisiones regulatorias tienen en sus vidas. Se est\u00e1n realizando esfuerzos para orientar la generaci\u00f3n, recopilaci\u00f3n y uso de datos en vida real (RWD) para respaldar la toma de decisiones, apoyar las evaluaciones cient\u00edficas y contribuir al desarrollo, autorizaci\u00f3n y uso seguro y eficaz de medicamentos. Pero para seguir avanzando en esta labor, habr\u00eda que asegurar una participaci\u00f3n significativa del paciente en todo el proceso, fomentando la colaboraci\u00f3n, y tambi\u00e9n la formaci\u00f3n continua, de los distintos stakeholders<\/em> para que esta participaci\u00f3n sea efectiva y orientada a las necesidades de estos pacientes. Dicha formaci\u00f3n mejorar\u00e1 el conocimiento colectivo y la aceptaci\u00f3n de nuevos enfoques.<\/p>\n\n\n\n

Segundo, la importancia de contar con unas normas claras que aporten seguridad jur\u00eddica en todo este proceso. Es necesario seguir estableciendo normas, gu\u00edas y protocolos que fomenten la investigaci\u00f3n y el uso de RWD, garantizando que los datos sean fiables y de calidad y se manejen de forma segura, cumpliendo con todas las garant\u00edas legales. Iniciativas ya en funcionamiento como la Red DARWIN EU<\/em>\u00ae, que facilita un elevado n\u00famero de RWD de calidad, van en la buena direcci\u00f3n, y est\u00e1n llamadas a jugar un papel esencial en este cambio de paradigma.<\/p>\n\n\n\n

Asimismo, es fundamental que la revisi\u00f3n de la legislaci\u00f3n farmac\u00e9utica de la UE y la implementaci\u00f3n de los reglamentos sobre Inteligencia Artificial, el Espacio Europeo de Datos Sanitarios y la Evaluaci\u00f3n de Tecnolog\u00edas Sanitarias est\u00e9n orientados tambi\u00e9n a lograr esta excelencia en la generaci\u00f3n de la evidencia cl\u00ednica. Todos estos elementos ser\u00e1n clave en el fortalecimiento de la competitividad de Europa en investigaci\u00f3n frente a otras regiones en crecimiento.<\/p>\n","protected":false},"excerpt":{"rendered":"

\u201cExcellence of clinical evidence is the heart of every well-informed decision on the development, authorization, reimbursement, use and monitoring of medicines\u201d. Con esta frase empieza el art\u00edculo \u201cClinical Evidence 2030\u201d recientemente publicado en la revista de la American Society for Clinical Pharmacology and Therapeutics. El art\u00edculo lo firman algunos de los representantes de las principales agencias nacionales del… <\/p>\n

<\/div>\n

Read More<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"inline_featured_image":false,"footnotes":""},"categories":[499,71],"tags":[],"coauthors":[106,202],"class_list":["post-37611","post","type-post","status-publish","format-standard","hentry","category-el-global","category-publications"],"acf":[],"yoast_head":"\nRetos y oportunidades del Real World Data - Faus Moliner<\/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:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Retos y oportunidades del Real World Data - Faus Moliner\" \/>\n<meta property=\"og:description\" content=\"\u201cExcellence of clinical evidence is the heart of every well-informed decision on the development, authorization, reimbursement, use and monitoring of medicines\u201d. Con esta frase empieza el art\u00edculo \u201cClinical Evidence 2030\u201d recientemente publicado en la revista de la American Society for Clinical Pharmacology and Therapeutics. El art\u00edculo lo firman algunos de los representantes de las principales agencias nacionales del... Read More\" \/>\n<meta property=\"og:url\" content=\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/\" \/>\n<meta property=\"og:site_name\" content=\"Faus Moliner\" \/>\n<meta property=\"article:published_time\" content=\"2025-02-24T09:06:39+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2025-02-24T09:12:16+00:00\" \/>\n<meta name=\"author\" content=\"Faus Moliner, Eduard Rodellar\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Faus Moliner, Eduard Rodellar\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"3 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"Article\",\"@id\":\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/#article\",\"isPartOf\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/\"},\"author\":{\"name\":\"Faus Moliner\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/b62ac2c67efed1b6f50872c1d6366f90\"},\"headline\":\"Retos y oportunidades del Real World Data\",\"datePublished\":\"2025-02-24T09:06:39+00:00\",\"dateModified\":\"2025-02-24T09:12:16+00:00\",\"mainEntityOfPage\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/\"},\"wordCount\":542,\"publisher\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\"},\"articleSection\":[\"El Global\",\"Publications\"],\"inLanguage\":\"en-US\"},{\"@type\":\"WebPage\",\"@id\":\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/\",\"url\":\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/\",\"name\":\"Retos y oportunidades del Real World Data - Faus Moliner\",\"isPartOf\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#website\"},\"datePublished\":\"2025-02-24T09:06:39+00:00\",\"dateModified\":\"2025-02-24T09:12:16+00:00\",\"breadcrumb\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/\"]}]},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Portada\",\"item\":\"https:\/\/faus-moliner.com\/en\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Retos y oportunidades del Real World Data\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#website\",\"url\":\"https:\/\/faus-moliner.com\/en\/\",\"name\":\"faus-moliner.com\",\"description\":\"Otro sitio realizado con WordPress\",\"publisher\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/faus-moliner.com\/en\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#organization\",\"name\":\"Faus Moliner\",\"url\":\"https:\/\/faus-moliner.com\/en\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg\",\"contentUrl\":\"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg\",\"width\":400,\"height\":283,\"caption\":\"Faus Moliner\"},\"image\":{\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/\"},\"sameAs\":[\"https:\/\/www.linkedin.com\/company\/2372042\/admin\/\"]},{\"@type\":\"Person\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/b62ac2c67efed1b6f50872c1d6366f90\",\"name\":\"Faus Moliner\",\"image\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/image\/88610ef99b0aa1c93ca33c569a053dac\",\"url\":\"https:\/\/secure.gravatar.com\/avatar\/be7b0f78e7edd64676ce7ea245b31f149a0cffff4b139c25ac02aaa676c19d67?s=96&d=mm&r=g\",\"contentUrl\":\"https:\/\/secure.gravatar.com\/avatar\/be7b0f78e7edd64676ce7ea245b31f149a0cffff4b139c25ac02aaa676c19d67?s=96&d=mm&r=g\",\"caption\":\"Faus Moliner\"},\"url\":\"https:\/\/faus-moliner.com\/en\/author\/moon\/\"}]}<\/script>\n<!-- \/ Yoast SEO plugin. -->","yoast_head_json":{"title":"Retos y oportunidades del Real World Data - Faus Moliner","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/","og_locale":"en_US","og_type":"article","og_title":"Retos y oportunidades del Real World Data - Faus Moliner","og_description":"\u201cExcellence of clinical evidence is the heart of every well-informed decision on the development, authorization, reimbursement, use and monitoring of medicines\u201d. Con esta frase empieza el art\u00edculo \u201cClinical Evidence 2030\u201d recientemente publicado en la revista de la American Society for Clinical Pharmacology and Therapeutics. El art\u00edculo lo firman algunos de los representantes de las principales agencias nacionales del... Read More","og_url":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/","og_site_name":"Faus Moliner","article_published_time":"2025-02-24T09:06:39+00:00","article_modified_time":"2025-02-24T09:12:16+00:00","author":"Faus Moliner, Eduard Rodellar","twitter_card":"summary_large_image","twitter_misc":{"Written by":"Faus Moliner, Eduard Rodellar","Est. reading time":"3 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"Article","@id":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/#article","isPartOf":{"@id":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/"},"author":{"name":"Faus Moliner","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/b62ac2c67efed1b6f50872c1d6366f90"},"headline":"Retos y oportunidades del Real World Data","datePublished":"2025-02-24T09:06:39+00:00","dateModified":"2025-02-24T09:12:16+00:00","mainEntityOfPage":{"@id":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/"},"wordCount":542,"publisher":{"@id":"https:\/\/faus-moliner.com\/en\/#organization"},"articleSection":["El Global","Publications"],"inLanguage":"en-US"},{"@type":"WebPage","@id":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/","url":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/","name":"Retos y oportunidades del Real World Data - Faus Moliner","isPartOf":{"@id":"https:\/\/faus-moliner.com\/en\/#website"},"datePublished":"2025-02-24T09:06:39+00:00","dateModified":"2025-02-24T09:12:16+00:00","breadcrumb":{"@id":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/"]}]},{"@type":"BreadcrumbList","@id":"https:\/\/faus-moliner.com\/en\/retos-y-oportunidades-del-real-world-data\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Portada","item":"https:\/\/faus-moliner.com\/en\/"},{"@type":"ListItem","position":2,"name":"Retos y oportunidades del Real World Data"}]},{"@type":"WebSite","@id":"https:\/\/faus-moliner.com\/en\/#website","url":"https:\/\/faus-moliner.com\/en\/","name":"faus-moliner.com","description":"Otro sitio realizado con WordPress","publisher":{"@id":"https:\/\/faus-moliner.com\/en\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/faus-moliner.com\/en\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/faus-moliner.com\/en\/#organization","name":"Faus Moliner","url":"https:\/\/faus-moliner.com\/en\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/","url":"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg","contentUrl":"https:\/\/faus-moliner.com\/wp-content\/uploads\/2023\/03\/Logo-FM-web.jpg","width":400,"height":283,"caption":"Faus Moliner"},"image":{"@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/logo\/image\/"},"sameAs":["https:\/\/www.linkedin.com\/company\/2372042\/admin\/"]},{"@type":"Person","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/b62ac2c67efed1b6f50872c1d6366f90","name":"Faus Moliner","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/faus-moliner.com\/en\/#\/schema\/person\/image\/88610ef99b0aa1c93ca33c569a053dac","url":"https:\/\/secure.gravatar.com\/avatar\/be7b0f78e7edd64676ce7ea245b31f149a0cffff4b139c25ac02aaa676c19d67?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/be7b0f78e7edd64676ce7ea245b31f149a0cffff4b139c25ac02aaa676c19d67?s=96&d=mm&r=g","caption":"Faus Moliner"},"url":"https:\/\/faus-moliner.com\/en\/author\/moon\/"}]}},"_links":{"self":[{"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/posts\/37611","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/comments?post=37611"}],"version-history":[{"count":1,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/posts\/37611\/revisions"}],"predecessor-version":[{"id":37613,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/posts\/37611\/revisions\/37613"}],"wp:attachment":[{"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/media?parent=37611"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/categories?post=37611"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/tags?post=37611"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/faus-moliner.com\/en\/wp-json\/wp\/v2\/coauthors?post=37611"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}