{"id":44054,"date":"2020-05-25T03:00:20","date_gmt":"2020-05-25T01:00:20","guid":{"rendered":"https:\/\/www.cde.ual.es\/?p=44054"},"modified":"2021-11-23T14:54:24","modified_gmt":"2021-11-23T13:54:24","slug":"international-coordination-to-encourage-the-conduct-of-covid-19-clinical-trials","status":"publish","type":"post","link":"https:\/\/www.cde.ual.es\/en\/international-coordination-to-encourage-the-conduct-of-covid-19-clinical-trials\/","title":{"rendered":"International coordination to encourage the conduct of COVID-19 clinical trials"},"content":{"rendered":"<p>Regulators are highlighting the need for a comprehensive <strong>international coordination mechanism<\/strong> to allow the conduct of adequately powered, randomised controlled trials, which can generate sound evidence on the effects of <strong>therapeutics or vaccines against COVID-19. <\/strong><\/p>\n<p><a href=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/close-up-view-of-person-holding-a-vaccine-4047183-2-scaled.jpg\"><img decoding=\"async\" class=\"size-medium wp-image-41824 aligncenter\" src=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/close-up-view-of-person-holding-a-vaccine-4047183-2-236x300.jpg\" alt=\"\" width=\"236\" height=\"300\" srcset=\"https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/close-up-view-of-person-holding-a-vaccine-4047183-2-236x300.jpg 236w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/close-up-view-of-person-holding-a-vaccine-4047183-2-807x1024.jpg 807w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/close-up-view-of-person-holding-a-vaccine-4047183-2-768x975.jpg 768w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/close-up-view-of-person-holding-a-vaccine-4047183-2-1210x1536.jpg 1210w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/close-up-view-of-person-holding-a-vaccine-4047183-2-1613x2048.jpg 1613w, https:\/\/www.cde.ual.es\/wp-content\/uploads\/2020\/04\/close-up-view-of-person-holding-a-vaccine-4047183-2-scaled.jpg 2017w\" sizes=\"(max-width: 236px) 100vw, 236px\" \/><\/a><\/p>\n<p>This follows a\u00a0call made by EMA\u2019s Human Medicines Committee (CHMP)\u00a0for the research community to pool resources into large, well-designed, multi-arm\u00a0clinical trials\u00a0to determine which investigational or repurposed medicines would be safe and effective for the treatment or prevention of COVID-19.<\/p>\n<p>Although the scientific community has responded to the COVID-19 challenge in an unprecedented manner, there are concerns about the growing number of COVID-19 stand-alone\u00a0clinical trials\u00a0with a small number of participants and observational studies, which might not generate the data required for regulatory decision-making.<\/p>\n<p>In an\u00a0<a class=\"ecl-link--external\" href=\"http:\/\/ascpt.onlinelibrary.wiley.com\/doi\/abs\/10.1002\/cpt.1891\" target=\"_blank\" rel=\"noopener noreferrer\">article published in Clinical Pharmacology &amp; Therapeutics,<\/a>\u00a0EMA authors have therefore set out concrete actions that stakeholders involved with COVID-19\u00a0clinical trials\u00a0should take to generate the type of conclusive evidence needed to enable rapid development and approval of potential treatments and vaccines against COVID-19. These include:<\/p>\n<ul>\n<li>research community to consider whether their planned trial can become part of a larger platform;<\/li>\n<li>developers of COVID-19 treatments to seek interactions with regulators as early as possible;<\/li>\n<li>support well-established public or private consortia to ramp up their activities and take on a wider role in the management of trials;<\/li>\n<li>regulatory flexibility in\u00a0clinical trial\u00a0management to address challenges arising from the COVID-19 pandemic, while ensuring a high level of quality,\u00a0efficacy\u00a0and safety of medicines;<\/li>\n<li>ethics committees to ensure that the benefits of conducting a stand-alone\u00a0clinical trial\u00a0for COVID-19 outweighs risks and burdens to the participants;<\/li>\n<li>establish infrastructure to support\u00a0clinical trial\u00a0conduct;<\/li>\n<li>umbrella patient organisations and learned societies to use their influence to encourage\u00a0clinical trial\u00a0coordination.<\/li>\n<\/ul>\n<p>Medicine regulatory authorities worldwide are cooperating under the umbrella of the\u00a0<a href=\"news:\/\/https:\/\/www.ema.europa.eu\/en\/partners-networks\/international-activities\/multilateral-organisations-initiatives\/international-coalition-medicines-regulatory-authorities-icmra\" target=\"_self\" rel=\"noopener noreferrer\">International Coalition of Medicines Regulatory Authorities (ICMRA)<\/a>\u00a0with the aim of expediting and streamlining the development of COVID-19 vaccines and treatments. In a series of ICMRA meetings on COVID-19 held in March and April 2020, they have exchanged information about regulatory issues, including prioritisation of COVID-19\u00a0clinical trials, and sought alignment in their approaches to enhance the efficiency and effectiveness of regulatory decision-making during the current pandemic.<\/p>\n<h3>More information<\/h3>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/international-coordination-needed-encourage-conduct-large-decision-relevant-covid-19-clinical-trials\">Full news<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of adequately powered, randomised controlled trials, which can generate sound evidence on the effects of therapeutics or vaccines against COVID-19. This follows a\u00a0call made by EMA\u2019s Human Medicines Committee (CHMP)\u00a0for the research community to pool resources into large, well-designed, multi-arm\u00a0clinical [&hellip;]<\/p>\n","protected":false},"author":101012,"featured_media":41824,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":"","footnotes":""},"categories":[4093,346,4092,4064],"tags":[1771,1352],"class_list":{"0":"post-44054","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-diseases","8":"category-eu-news","9":"category-health","10":"category-institutional","11":"tag-clinical-trials","12":"tag-covid-19","13":"entry"},"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>International coordination to encourage the conduct of COVID-19 clinical trials | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda<\/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:\/\/www.cde.ual.es\/en\/international-coordination-to-encourage-the-conduct-of-covid-19-clinical-trials\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"International coordination to encourage the conduct of COVID-19 clinical trials | CDE Almer\u00eda - Centro de Documentaci\u00f3n Europea - Universidad de Almer\u00eda\" \/>\n<meta property=\"og:description\" content=\"Regulators are highlighting the need for a comprehensive international coordination mechanism to allow the conduct of adequately powered, randomised controlled trials, which can generate sound evidence on the effects of therapeutics or vaccines against COVID-19. 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