{"id":6674,"date":"2024-05-31T10:46:17","date_gmt":"2024-05-31T08:46:17","guid":{"rendered":"https:\/\/www.biomeris.it\/?p=6674"},"modified":"2024-05-31T10:47:55","modified_gmt":"2024-05-31T08:47:55","slug":"real-world-evidence","status":"publish","type":"post","link":"https:\/\/www.biomeris.it\/en\/real-world-evidence\/","title":{"rendered":"Real World Evidence"},"content":{"rendered":"<p>As the name itself suggests, the definition \u201creal world evidence\u201d (RWE) indicates scientific evidence derived from the real world, i.e. the output of analysis of data coming from a patient\u2019s daily life (\u201creal world data\u201d, RWD).<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6655 aligncenter\" src=\"https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/rwd.jpg\" alt=\"\" width=\"1509\" height=\"998\" srcset=\"https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/rwd.jpg 1509w, https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/rwd-300x198.jpg 300w, https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/rwd-1030x681.jpg 1030w, https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/rwd-768x508.jpg 768w, https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/rwd-1500x992.jpg 1500w, https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/rwd-705x466.jpg 705w\" sizes=\"auto, (max-width: 1509px) 100vw, 1509px\" \/><\/p>\n<p>RWD are originated from numerous sources, among which electronic health records, administrative logs (e.g. for reimbursements or activity monitoring), pathology registers and non-clinical sources capable of providing information on the state of health (e.g., mobile and\/or wearable devices).<\/p>\n<p>An RWE-based approach favors research from several points of view, improving the planning of processes from the clinical, management and financial point of view<strong>.<\/strong><\/p>\n<p>An example of the above described situation comes from the <a href=\"https:\/\/www.openaccessjournals.com\/articles\/an-evidencebased-approach-to-conducting-clinical-trial-feasibility-assessments.pdf\" target=\"_blank\" rel=\"noopener\">issues stemming from inadequate planning<\/a>, which affect clinical trials causing delays- or even, in extreme cases, the failure of the set objectives.<\/p>\n<ul>\n<li>11% of the involved investigators enroll no patient at all<\/li>\n<li>48% of the investigators underperform with respect to the trial\u2019s requirements (low number of enrolled patients)<\/li>\n<li>80% of the enrolment timelines for Phase II-IV studies are not met<\/li>\n<li>As a consequence, an extension of the timelines (sometimes even requiring twice the initially estimated time) to allow meeting the enrolment quota<\/li>\n<li>On average, about half the patients get to the completion of the study<\/li>\n<\/ul>\n<p>It is clear how the management of these unforeseen situations affects not only the scientific aspect of a trial, but also the financial one, by significantly impacting the size of the investment necessary to meet the set goals.<\/p>\n<p>A data driven approach to the feasibility analysis for trials allows the execution of estimations that are more precise and helps containing the above listed issues.<\/p>\n<p>This analysis (patients eligibility assessment) is traditionally carried out through surveys for potential investigators. Instruments exist that allow the optimization of the evaluation process.<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6659 alignleft\" src=\"https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/datawarehouse.png\" alt=\"\" width=\"280\" height=\"248\" \/><\/p>\n<p>The availability of research data warehouses (DWH)- i.e. an aggregator of data originating from different sources- facilitates a fast, accurate and reliable assessment.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p><img loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-6657 alignright\" src=\"https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/reti-dwh.png\" alt=\"\" width=\"363\" height=\"333\" srcset=\"https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/reti-dwh.png 363w, https:\/\/www.biomeris.it\/wp-content\/uploads\/2024\/05\/reti-dwh-300x275.png 300w\" sizes=\"auto, (max-width: 363px) 100vw, 363px\" \/><\/p>\n<p>The creation of DWH networks based on a common data model (CDM) bringing together different centers favors a federated approach to research: the sharing of aggregated data and the implementation of semi-automated procedures that can work in all the nodes of the network<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>The exploitation of <a href=\"https:\/\/www.biomeris.it\/en\/standard-terminologies\/\" target=\"_blank\" rel=\"noopener\">standard terminologies<\/a>, the use of a <a href=\"https:\/\/www.biomeris.it\/en\/services\/omop-ohdsi\/\" target=\"_blank\" rel=\"noopener\">common data model<\/a> and the alignment of the data sources to <a href=\"https:\/\/www.biomeris.it\/en\/introduction-fair-principles\/\" target=\"_blank\" rel=\"noopener\">the FAIR principles<\/a>, all of which are covered in other insights on this site, are essential elements to ensure interoperability within a federated infrastructure.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>As the name itself suggests, the definition \u201creal world evidence\u201d (RWE) indicates scientific evidence derived from the real world, i.e. the output of analysis of data coming from a patient\u2019s daily life (\u201creal world data\u201d, RWD). RWD are originated from numerous sources, among which electronic health records, administrative logs (e.g. for reimbursements or activity monitoring), [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":6655,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[188,171,193],"tags":[],"class_list":["post-6674","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-focus","category-news","category-omop-en"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 5.0.0.1 - aioseo.com -->\n\t<meta name=\"description\" content=\"As the name itself suggests, the definition \u201creal world evidence\u201d (RWE) indicates scientific evidence derived from the real world, i.e. the output of analysis of data coming from a patient\u2019s daily life (\u201creal world data\u201d, RWD). RWD are originated from numerous sources, among which electronic health records, administrative logs (e.g. for reimbursements or activity monitoring),\" \/>\n\t<meta name=\"robots\" content=\"max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n\t<meta name=\"author\" content=\"rita-biomeris\"\/>\n\t<link rel=\"canonical\" href=\"https:\/\/www.biomeris.it\/en\/real-world-evidence\/\" \/>\n\t<meta name=\"generator\" content=\"All in One SEO (AIOSEO) 5.0.0.1\" \/>\n\t\t<meta property=\"og:locale\" content=\"en_US\" \/>\n\t\t<meta property=\"og:site_name\" content=\"Biomeris |\" \/>\n\t\t<meta property=\"og:type\" content=\"article\" \/>\n\t\t<meta property=\"og:title\" content=\"Real World Evidence | Biomeris\" \/>\n\t\t<meta property=\"og:description\" content=\"As the name itself suggests, the definition \u201creal world evidence\u201d (RWE) indicates scientific evidence derived from the real world, i.e. the output of analysis of data coming from a patient\u2019s daily life (\u201creal world data\u201d, RWD). 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