{"id":6419,"date":"2021-12-29T08:13:37","date_gmt":"2021-12-29T08:13:37","guid":{"rendered":"http:\/\/164.90.225.225\/2023\/05\/02\/widespread-use-of-real-world-evidence-in-eu-medicines-regulation\/"},"modified":"2023-05-25T12:08:09","modified_gmt":"2023-05-25T11:08:09","slug":"widespread-use-of-real-world-evidence-in-eu-medicines-regulation","status":"publish","type":"post","link":"https:\/\/www.quinta.cz\/cs\/2021\/12\/29\/widespread-use-of-real-world-evidence-in-eu-medicines-regulation\/","title":{"rendered":"Widespread use of real-world evidence in EU medicines regulation"},"content":{"rendered":"

Widespread use of real-world evidence in EU medicines regulation. Is it possible by 2025?<\/p>\n

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That\u2019s certainly the aim and vision of the European Medicines Agency<\/p>\n

Real-world data (RWD) and real-world evidence (RWE) are already partially used in the regulation of the development, authorization, and supervision of some selected medicines across the EU, but the vision is that by 2025 the use of RWE will have been fully enabled and the value will have been established across the whole spectrum of regulatory use cases.<\/p>\n

Aiming to complement rather than replace randomized clinical trials (RCTs), which are currently the gold standard demonstrators of the efficacy of a medicine, the vision is that both RWE and RCTs strengths will be jointly utilized in accordance with their importance to each regulatory question, and that a rigorous and systematic approach to \u2018learning from doing\u2019 be established.<\/p>\n

To aid this objective, the agency is creating a \u2018Data Analytics and Real World Interrogation Network\u2019 which they say will be key to delivering this vision. This EU-wide network, due to launch early next year, will allow access to healthcare data from across the EU and will onboard data partners to drive the conduct of studies requested by medicines regulators and, at a later stage, by other stakeholders.<\/p>\n

If successful, delivering it will support the development and use of better medicines for patients, and of better information for healthcare professionals, industry, regulatory and public health agencies, academia, and more.<\/p>\n

As providers of a plethora of pharma services, including clinical trials, in their own in-house facilities, QUINTA-ANALYTICA support and encourage such forward-thinking, and indeed any other proposal whose goal aligns with theirs – that of enabling the best medicines that science can offer.<\/p>\n

Learn more about Quinta\u2019s services and ethos by getting in touch with us today.<\/p>\n","protected":false},"excerpt":{"rendered":"

Real-world data and real-world evidence are already used in the regulation of some medicines across the EU, but the vision is that by 2025 the use of RWE will have been fully enabled.<\/p>\n","protected":false},"author":6,"featured_media":6420,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-6419","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorised"],"_links":{"self":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6419","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/comments?post=6419"}],"version-history":[{"count":2,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6419\/revisions"}],"predecessor-version":[{"id":7801,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/posts\/6419\/revisions\/7801"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/media\/6420"}],"wp:attachment":[{"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/media?parent=6419"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/categories?post=6419"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.quinta.cz\/cs\/wp-json\/wp\/v2\/tags?post=6419"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}