{"id":13473,"date":"2022-10-03T08:00:08","date_gmt":"2022-10-03T06:00:08","guid":{"rendered":"https:\/\/saludporderecho.org\/?p=13473"},"modified":"2022-09-29T15:25:01","modified_gmt":"2022-09-29T13:25:01","slug":"desigualdades-en-la-transparencia-sobre-los-ensayos-clinicos-en-europa","status":"publish","type":"post","link":"https:\/\/saludporderecho.org\/en\/desigualdades-en-la-transparencia-sobre-los-ensayos-clinicos-en-europa\/","title":{"rendered":"Inequalities in transparency about clinical trials results in Europe"},"content":{"rendered":"<p><strong>The majority of unreported drug trial results in Europe are now concentrated within just four countries, highlighting the strong differences in regulatory quality between European Union member states, <span class=\"VIiyi\" lang=\"en\"><span class=\"JLqJ4b ChMk0b\"><span class=\"Q4iAWc\">shows a new report, led by Transparimed and supported by other organizations, including Salud por Derecho.<\/span><\/span><\/span><br \/>\n<\/strong><\/p>\n<p>National medicines regulators that proactively chase up missing clinical trial results with pharma companies and universities have succeeded in significantly boosting reporting rates. This includes regulators in <strong><em>Germany, Austria, Denmark<\/em><\/strong> and <strong><em>Belgium<\/em><\/strong>.<\/p>\n<p>In contrast, the number of missing results has further grown in <strong><em>Italy<\/em><\/strong> and <strong><em>France<\/em><\/strong>. In <strong><em>Italy<\/em><\/strong> alone, an estimated 1,299 clinical trial results are now missing in violation of European transparency rules.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-13464\" src=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2022\/09\/Missing-results-2020-2022.jpg\" alt=\"\" width=\"566\" height=\"452\" srcset=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2022\/09\/Missing-results-2020-2022.jpg 566w, https:\/\/saludporderecho.org\/wp-content\/uploads\/2022\/09\/Missing-results-2020-2022-300x240.jpg 300w\" sizes=\"(max-width: 566px) 100vw, 566px\" \/><\/p>\n<p>Between them, national medicines regulators in Europe have failed to ensure the publication of <strong><em>at least 5,488 clinical trial results<\/em><\/strong> for which they are unambiguously responsible.<\/p>\n<p><em>Note: Actual figures are almost certainly higher as the estimates below include only single-country trials that were approved up to 2015.<\/em><\/p>\n<p>On the positive side, strong engagement by the <strong><em>European Medicines Agency<\/em><\/strong> at the central level has boosted relative trial reporting rates across all countries since December 2020. Parallel engagement by national regulators has considerably added to this positive momentum. <strong><em>Germany<\/em><\/strong> and <strong><em>Austria<\/em><\/strong> have now achieved high reporting rates, and <strong><em>Denmark<\/em><\/strong> and <strong><em>Belgium<\/em><\/strong> have made substantial progress.<\/p>\n<p>The star performer is <strong><em>Austria<\/em><\/strong>, where the national regulator\u2019s strong outreach to trial sponsors has boosted the reporting rate from 26% to 65% within less than two years.<\/p>\n<p><img decoding=\"async\" class=\"aligncenter size-full wp-image-13466\" src=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2022\/09\/Percent-with-results-2020-2022.jpg\" alt=\"\" width=\"667\" height=\"502\" srcset=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2022\/09\/Percent-with-results-2020-2022.jpg 667w, https:\/\/saludporderecho.org\/wp-content\/uploads\/2022\/09\/Percent-with-results-2020-2022-300x226.jpg 300w\" sizes=\"(max-width: 667px) 100vw, 667px\" \/><\/p>\n<p>Regulators in <strong><em>Italy<\/em><\/strong>, <strong><em>Spain<\/em><\/strong> and <strong><em>France<\/em><\/strong> still be appear to be ignoring the problem, a separate <a href=\"https:\/\/www.transparimed.org\/single-post\/clinical-trial-regulation-europe\">report published last week<\/a> suggests. In contrast, <strong><em>Netherlands<\/em><\/strong> regulator CCMO recently hired someone to chase up missing Dutch trial results.<\/p>\n<p>Commenting on the report, Tilly Metz, health spokesperson for the Greens in the European Parliament, said:<\/p>\n<p><strong><em>&#8220;I am very disappointed in the lack of political will to ensure the transparency of clinical trials data in some member states. I am calling on them to remedy this situation and stop hindering their EU counterpart\u2019s efforts.\u201d <\/em><\/strong><\/p>\n<p><em>\u201cTransparency of clinical trials data is an important basis to boost research efforts at EU level where it is needed and therefore make the best use of public money.&#8221;<\/em><\/p>\n<p>G\u00e9rard Raymond, President of <a href=\"https:\/\/www.france-assos-sante.org\/\">France Assos Sant\u00e9<\/a>, said:<\/p>\n<p><strong><em>&#8220;The low publication rate of clinical trial results in France is harmful to the interests of patients because it limits the information available on the safety, efficacy and actual therapeutic value of the tested products.\u201d <\/em><\/strong><\/p>\n<p><em>\u201cThe French health authorities need to enforce the obligation to publish trial results within one year and should adopt dissuasive sanctions in case of non-compliance, as other European countries have done.&#8221;<\/em><\/p>\n<p>Patient advocate Bettina Ryll of the Melanoma Patient Network Europe said:<\/p>\n<p><em>\u201cIt is depressing to see that academic institutions continue to fail in reporting the outcomes of clinical trials that are conducted on citizens and financed with public money. Maybe the eligibility criteria for receiving funding from European programs like the Cancer Mission or EU4Health should include successfully reported clinical trials.\u201d<\/em><\/p>\n<p>Till Bruckner, founder of TranspariMED, said:<\/p>\n<p><strong><em>\u201cThe European Medicines Agency and many national medicines regulators have been remarkably successful at improving clinical trial reporting and thereby reducing costly research waste, demonstrating that this is a problem that can be fixed.\u201d<\/em><\/strong><\/p>\n<p><em>\u201cThe continued apathy of regulators in Italy, France and Spain puts thousands of older clinical trial results at risk of being lost forever. Unless they reach out to sponsors now, there will be an epidemic of law-breaking in the near future, as many research institutions in those countries are completely unprepared for compliance with the new Clinical Trial Regulation.\u201d <\/em><\/p>\n<p>The full report can be downloaded <a href=\"https:\/\/saludporderecho.org\/wp-content\/uploads\/2022\/09\/Missing-clinical-trial-data-in-Europe_TranspariMED_20221003.pdf\">here<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The majority of unreported drug trial results in Europe are now concentrated within just four countries, highlighting the strong differences in regulatory quality between European Union member states, shows a<\/p>\n","protected":false},"author":2,"featured_media":13471,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[309],"tags":[975,976,411,977,696,978,782,979],"class_list":["post-13473","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-slider-en","tag-agencias-reguladoras-en","tag-ensayos-clinicos-en","tag-espana-en","tag-francia-en","tag-sin-categoria","tag-sin-categoria-en-13","tag-sin-categoria-en-2","tag-sin-categoria-en-14"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.5 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Inequalities in transparency about clinical trials results in Europe | Salud por Derecho<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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