{"id":4705,"date":"2020-03-13T16:56:55","date_gmt":"2020-03-13T16:56:55","guid":{"rendered":"https:\/\/live-ubc-llc.pantheonsite.io\/?p=641"},"modified":"2025-05-15T19:17:46","modified_gmt":"2025-05-15T19:17:46","slug":"ispes-position-on-real-world-evidence-rwe","status":"publish","type":"insights","link":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/","title":{"rendered":"ISPE\u2019s Position on Real World Evidence (RWE)"},"content":{"rendered":"\n<p>In February 2020, the International Society for Pharmacoepidemiology (ISPE) released a position statement on Real World Evidence (RWE). Here is a summary (You can read the full statement <a href=\"https:\/\/pharmacoepi.org\/pub\/?id=136DECF1-C559-BA4F-92C4-CF6E3ED16BB6\" target=\"_blank\" rel=\"noreferrer noopener\">here<\/a>):<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>ISPE has contributed to the development of RWE methods for more than 30 years<\/li>\n\n\n\n<li>ISPE applies robust epidemiological, causal inference, and data science methods using a wide variety of Real World Data (RWD) sources (e.g., electronic health records and registries)<\/li>\n\n\n\n<li>Randomized controlled trials (RCTs) will continue to serve as the major evidentiary standard for regulatory approvals, however<strong>, RWE derived from well-designed studies, with the application of rigorous epidemiologic methods, combined with judicious interpretation, can offer robust evidence regarding safety <\/strong><strong><em><u>and<\/u><\/em><\/strong><strong> effectiveness.<\/strong><\/li>\n\n\n\n<li>ISPE is encouraged to see regulatory agencies now considering RWE to support new indications, labeling changes, and for the approval of new products.<\/li>\n\n\n\n<li>ISPE members can provide guidance and drive innovative solutions on key RWE issues, including identifying the optimal study design and which data sources are \u201cfit for purpose,\u201d amongst others.<\/li>\n<\/ul>\n\n\n\n<p>In summary, <strong>ISPE leads and drives exciting new developments in RWE via the breadth of experience and expertise in epidemiologic research of its members,<\/strong> and seeks to collaborate with key stakeholders to further the use and science of RWE.<\/p>\n\n\n\n<p><a href=\"https:\/\/ubc.com\/solution\/evidence-development\/\" target=\"_blank\" rel=\"noreferrer noopener\">Learn more<\/a> about UBC\u2019s expertise and consulting capabilities in accelerating evidence generation.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Read more about the February 2020 position on RWE from ISPE.<\/p>\n","protected":false},"featured_media":10677,"parent":0,"menu_order":0,"comment_status":"open","ping_status":"open","template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"insights_category":[33],"insights_tags":[107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,106,135,136,138,139,140,141,142],"class_list":["post-4705","insights","type-insights","status-publish","format-standard","has-post-thumbnail","hentry","insights_category-blog","insights_tags-anesthesiology","insights_tags-cardiology","insights_tags-dental-and-oral-health","insights_tags-dermatology","insights_tags-endocrinology","insights_tags-gastroenterology","insights_tags-genetic-diseases","insights_tags-gynecology","insights_tags-hematology","insights_tags-hepatology","insights_tags-immunology","insights_tags-infectious-diseases","insights_tags-medical-devices","insights_tags-mens-health","insights_tags-metabolic-diseases","insights_tags-musculoskeletal","insights_tags-nephrology","insights_tags-neurology","insights_tags-obstetrics","insights_tags-oncology","insights_tags-ophthalmology","insights_tags-orthopedics-orthopedic-surgery","insights_tags-otolaryngology","insights_tags-pain","insights_tags-palliative-care","insights_tags-pediatrics-neonatology","insights_tags-podiatry","insights_tags-psychiatry","insights_tags-pulmonary-respiratory-diseases","insights_tags-rare-and-orphan-diseases","insights_tags-rheumatology","insights_tags-surgery","insights_tags-transplantation","insights_tags-trauma","insights_tags-urology","insights_tags-vascular-diseases"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.7 (Yoast SEO v26.1.1) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ISPE\u2019s Position on Real World Evidence (RWE) - UBC<\/title>\n<meta name=\"description\" content=\"Real World Evidence has become a critical piece of the evidence generation puzzle, leading ISPE to release a statement on it&#039;s application.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"ISPE\u2019s Position on Real World Evidence (RWE)\" \/>\n<meta property=\"og:description\" content=\"Real World Evidence has become a critical piece of the evidence generation puzzle, leading ISPE to release a statement on it&#039;s application.\" \/>\n<meta property=\"og:url\" content=\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/\" \/>\n<meta property=\"og:site_name\" content=\"UBC\" \/>\n<meta property=\"article:modified_time\" content=\"2025-05-15T19:17:46+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/ubc.com\/wp-content\/uploads\/2020\/03\/ISPE-Position-on-RWE-1275x1080-1.png\" \/>\n\t<meta property=\"og:image:width\" content=\"1275\" \/>\n\t<meta property=\"og:image:height\" content=\"1080\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"2 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/\",\"url\":\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/\",\"name\":\"ISPE\u2019s Position on Real World Evidence (RWE) - UBC\",\"isPartOf\":{\"@id\":\"https:\/\/ubc.com\/#website\"},\"primaryImageOfPage\":{\"@id\":\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#primaryimage\"},\"image\":{\"@id\":\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#primaryimage\"},\"thumbnailUrl\":\"https:\/\/ubc.com\/wp-content\/uploads\/2020\/03\/ISPE-Position-on-RWE-1275x1080-1.png\",\"datePublished\":\"2020-03-13T16:56:55+00:00\",\"dateModified\":\"2025-05-15T19:17:46+00:00\",\"description\":\"Real World Evidence has become a critical piece of the evidence generation puzzle, leading ISPE to release a statement on it's application.\",\"breadcrumb\":{\"@id\":\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#breadcrumb\"},\"inLanguage\":\"en-US\",\"potentialAction\":[{\"@type\":\"ReadAction\",\"target\":[\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/\"]}]},{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#primaryimage\",\"url\":\"https:\/\/ubc.com\/wp-content\/uploads\/2020\/03\/ISPE-Position-on-RWE-1275x1080-1.png\",\"contentUrl\":\"https:\/\/ubc.com\/wp-content\/uploads\/2020\/03\/ISPE-Position-on-RWE-1275x1080-1.png\",\"width\":1275,\"height\":1080,\"caption\":\"Business man looking at a tablet on the table and thinking as he studies the charts and graphs popping out of the screen.\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#breadcrumb\",\"itemListElement\":[{\"@type\":\"ListItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\/\/ubc.com\/\"},{\"@type\":\"ListItem\",\"position\":2,\"name\":\"Insights\",\"item\":\"https:\/\/ubc.com\/insights\/\"},{\"@type\":\"ListItem\",\"position\":3,\"name\":\"ISPE\u2019s Position on Real World Evidence (RWE)\"}]},{\"@type\":\"WebSite\",\"@id\":\"https:\/\/ubc.com\/#website\",\"url\":\"https:\/\/ubc.com\/\",\"name\":\"UBC\",\"description\":\"\",\"publisher\":{\"@id\":\"https:\/\/ubc.com\/#organization\"},\"potentialAction\":[{\"@type\":\"SearchAction\",\"target\":{\"@type\":\"EntryPoint\",\"urlTemplate\":\"https:\/\/ubc.com\/?s={search_term_string}\"},\"query-input\":{\"@type\":\"PropertyValueSpecification\",\"valueRequired\":true,\"valueName\":\"search_term_string\"}}],\"inLanguage\":\"en-US\"},{\"@type\":\"Organization\",\"@id\":\"https:\/\/ubc.com\/#organization\",\"name\":\"UBC\",\"url\":\"https:\/\/ubc.com\/\",\"logo\":{\"@type\":\"ImageObject\",\"inLanguage\":\"en-US\",\"@id\":\"https:\/\/ubc.com\/#\/schema\/logo\/image\/\",\"url\":\"https:\/\/ubc.com\/wp-content\/uploads\/2023\/07\/Layer_1.png\",\"contentUrl\":\"https:\/\/ubc.com\/wp-content\/uploads\/2023\/07\/Layer_1.png\",\"width\":188,\"height\":50,\"caption\":\"UBC\"},\"image\":{\"@id\":\"https:\/\/ubc.com\/#\/schema\/logo\/image\/\"}}]}<\/script>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"ISPE\u2019s Position on Real World Evidence (RWE) - UBC","description":"Real World Evidence has become a critical piece of the evidence generation puzzle, leading ISPE to release a statement on it's application.","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:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/","og_locale":"en_US","og_type":"article","og_title":"ISPE\u2019s Position on Real World Evidence (RWE)","og_description":"Real World Evidence has become a critical piece of the evidence generation puzzle, leading ISPE to release a statement on it's application.","og_url":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/","og_site_name":"UBC","article_modified_time":"2025-05-15T19:17:46+00:00","og_image":[{"width":1275,"height":1080,"url":"https:\/\/ubc.com\/wp-content\/uploads\/2020\/03\/ISPE-Position-on-RWE-1275x1080-1.png","type":"image\/png"}],"twitter_card":"summary_large_image","twitter_misc":{"Est. reading time":"2 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/","url":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/","name":"ISPE\u2019s Position on Real World Evidence (RWE) - UBC","isPartOf":{"@id":"https:\/\/ubc.com\/#website"},"primaryImageOfPage":{"@id":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#primaryimage"},"image":{"@id":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#primaryimage"},"thumbnailUrl":"https:\/\/ubc.com\/wp-content\/uploads\/2020\/03\/ISPE-Position-on-RWE-1275x1080-1.png","datePublished":"2020-03-13T16:56:55+00:00","dateModified":"2025-05-15T19:17:46+00:00","description":"Real World Evidence has become a critical piece of the evidence generation puzzle, leading ISPE to release a statement on it's application.","breadcrumb":{"@id":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#breadcrumb"},"inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#primaryimage","url":"https:\/\/ubc.com\/wp-content\/uploads\/2020\/03\/ISPE-Position-on-RWE-1275x1080-1.png","contentUrl":"https:\/\/ubc.com\/wp-content\/uploads\/2020\/03\/ISPE-Position-on-RWE-1275x1080-1.png","width":1275,"height":1080,"caption":"Business man looking at a tablet on the table and thinking as he studies the charts and graphs popping out of the screen."},{"@type":"BreadcrumbList","@id":"https:\/\/ubc.com\/insights\/ispes-position-on-real-world-evidence-rwe\/#breadcrumb","itemListElement":[{"@type":"ListItem","position":1,"name":"Home","item":"https:\/\/ubc.com\/"},{"@type":"ListItem","position":2,"name":"Insights","item":"https:\/\/ubc.com\/insights\/"},{"@type":"ListItem","position":3,"name":"ISPE\u2019s Position on Real World Evidence (RWE)"}]},{"@type":"WebSite","@id":"https:\/\/ubc.com\/#website","url":"https:\/\/ubc.com\/","name":"UBC","description":"","publisher":{"@id":"https:\/\/ubc.com\/#organization"},"potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/ubc.com\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Organization","@id":"https:\/\/ubc.com\/#organization","name":"UBC","url":"https:\/\/ubc.com\/","logo":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/ubc.com\/#\/schema\/logo\/image\/","url":"https:\/\/ubc.com\/wp-content\/uploads\/2023\/07\/Layer_1.png","contentUrl":"https:\/\/ubc.com\/wp-content\/uploads\/2023\/07\/Layer_1.png","width":188,"height":50,"caption":"UBC"},"image":{"@id":"https:\/\/ubc.com\/#\/schema\/logo\/image\/"}}]}},"_links":{"self":[{"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/insights\/4705","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/insights"}],"about":[{"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/types\/insights"}],"replies":[{"embeddable":true,"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/comments?post=4705"}],"version-history":[{"count":9,"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/insights\/4705\/revisions"}],"predecessor-version":[{"id":12783,"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/insights\/4705\/revisions\/12783"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/media\/10677"}],"wp:attachment":[{"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/media?parent=4705"}],"wp:term":[{"taxonomy":"insights_category","embeddable":true,"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/insights_category?post=4705"},{"taxonomy":"insights_tags","embeddable":true,"href":"https:\/\/ubc.com\/wp-json\/wp\/v2\/insights_tags?post=4705"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}