{"id":5823,"date":"2019-06-18T16:18:57","date_gmt":"2019-06-18T16:18:57","guid":{"rendered":"https:\/\/thepublicationplan.com\/?p=5823"},"modified":"2019-06-19T06:58:27","modified_gmt":"2019-06-19T06:58:27","slug":"are-european-universities-failing-to-report-clinical-trial-data-in-a-timely-manner","status":"publish","type":"post","link":"https:\/\/thepublicationplan.com\/2019\/06\/18\/are-european-universities-failing-to-report-clinical-trial-data-in-a-timely-manner\/","title":{"rendered":"Are European universities failing to report clinical trial data in a timely manner?"},"content":{"rendered":"<p><img data-recalc-dims=\"1\" loading=\"lazy\" decoding=\"async\" data-attachment-id=\"5824\" data-permalink=\"https:\/\/thepublicationplan.com\/2019\/06\/18\/are-european-universities-failing-to-report-clinical-trial-data-in-a-timely-manner\/sand-running-through-the-bulbs-of-an-hourglass\/\" data-orig-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/06\/EUCTR-reporting.jpg?fit=721%2C485&amp;ssl=1\" data-orig-size=\"721,485\" data-comments-opened=\"1\" data-image-meta=\"{&quot;aperture&quot;:&quot;0&quot;,&quot;credit&quot;:&quot;Getty Images\/iStockphoto&quot;,&quot;camera&quot;:&quot;&quot;,&quot;caption&quot;:&quot;Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copyspace&quot;,&quot;created_timestamp&quot;:&quot;0&quot;,&quot;copyright&quot;:&quot;serggn&quot;,&quot;focal_length&quot;:&quot;0&quot;,&quot;iso&quot;:&quot;0&quot;,&quot;shutter_speed&quot;:&quot;0&quot;,&quot;title&quot;:&quot;Sand running through the bulbs of an hourglass&quot;,&quot;orientation&quot;:&quot;1&quot;}\" data-image-title=\"Sand running through the bulbs of an hourglass\" data-image-description=\"\" data-image-caption=\"&lt;p&gt;Sand running through the bulbs of an hourglass measuring the passing time in a countdown to a deadline, on a dark background with copyspace&lt;\/p&gt;\n\" data-medium-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/06\/EUCTR-reporting.jpg?fit=300%2C202&amp;ssl=1\" data-large-file=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/06\/EUCTR-reporting.jpg?fit=721%2C485&amp;ssl=1\" class=\"alignnone size-full wp-image-5824\" src=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/06\/EUCTR-reporting.jpg?resize=721%2C485&#038;ssl=1\" alt=\"EUCTR reporting.jpg\" width=\"721\" height=\"485\" srcset=\"https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/06\/EUCTR-reporting.jpg?w=721&amp;ssl=1 721w, https:\/\/i0.wp.com\/thepublicationplan.com\/wp-content\/uploads\/2019\/06\/EUCTR-reporting.jpg?resize=300%2C202&amp;ssl=1 300w\" sizes=\"auto, (max-width: 721px) 100vw, 721px\" \/><\/p>\n<p><a href=\"https:\/\/www.ema.europa.eu\/en\/news\/posting-clinical-trial-summary-results-european-clinical-trials-database-eudract-become-mandatory\" target=\"_blank\" rel=\"noopener noreferrer\">European Union (EU) regulations<\/a> mandate that sponsors of interventional clinical trials registered on the <a href=\"https:\/\/www.clinicaltrialsregister.eu\/\" target=\"_blank\" rel=\"noopener noreferrer\">European Clinical Trials Database (EudraCT)<\/a> should publish their results on EudraCT within 12 months of trial completion (6 months for paediatric trials). Certain details, including trial protocols and data subsets, are then made accessible to the public via the <a href=\"https:\/\/www.clinicaltrialsregister.eu\/\" target=\"_blank\" rel=\"noopener noreferrer\">EU Clinical Trials Register (EUCTR)<\/a>. Despite these regulations, a recent joint <a href=\"https:\/\/docs.wixstatic.com\/ugd\/01f35d_42e869002189401d80a672d4ecff3f73.pdf?index=true\" target=\"_blank\" rel=\"noopener noreferrer\">report<\/a> on clinical trial transparency by <a href=\"https:\/\/www.transparimed.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">TranspariMED<\/a>, <a href=\"https:\/\/www.bukopharma.de\/index.php\/de\/\" target=\"_blank\" rel=\"noopener noreferrer\">BUKO Pharma-Kampagne<\/a>, <a href=\"https:\/\/www.test-aankoop.be\/\" target=\"_blank\" rel=\"noopener noreferrer\">Test Aankoop<\/a> and <a href=\"http:\/\/haiweb.org\/\" target=\"_blank\" rel=\"noopener noreferrer\">Health Action International<\/a> identified that 83% of eligible clinical trials run by 30 European universities were missing results on the EUCTR. The results and implications of the report are discussed in detail by Nic Fleming in a <a href=\"https:\/\/www.nature.com\/articles\/d41586-019-01389-y\" target=\"_blank\" rel=\"noopener noreferrer\">news article<\/a> published in <em><a href=\"https:\/\/www.nature.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Nature<\/a><\/em>.<\/p>\n<p>Fleming highlights that in the worst case an institution reported data from only 7% of the 188 trials they were due to have reported on. Furthermore, universities running eligible trials in four European countries (France, Italy, Sweden and Norway) had not posted any results. The author of the full report, <a href=\"https:\/\/www.linkedin.com\/in\/tillbruckner\/?originalSubdomain=uk\" target=\"_blank\" rel=\"noopener noreferrer\">Dr Till Bruckner<\/a> (TranspariMED), also notes that the situation has likely been underestimated, as many of the old trials listed on EUCTR as \u2018ongoing\u2019 may have completed, but their status and results have not been updated.<\/p>\n<p>Fleming has observed <a href=\"https:\/\/www.nature.com\/articles\/d41586-019-00994-1\" target=\"_blank\" rel=\"noopener noreferrer\">a similar situation in the US with regards to trial reporting<\/a>. A recent <a href=\"http:\/\/www.altreroute.com\/clinicaltrials\/assets\/download\/UniversityTransparencyReport2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">study<\/a> identified 25 US universities that were in violation of <a href=\"https:\/\/thepublicationplan.com\/2016\/09\/22\/the-final-rule-clarifies-and-expands-clinical-trial-reporting-requirements\/\" target=\"_blank\" rel=\"noopener noreferrer\">US trial disclosure law<\/a>, which requires sponsors of certain applicable clinical trials of FDA-regulated products to post clinical trial data within 12 months of trial completion.<\/p>\n<p>However, it\u2019s not all doom and gloom \u2013 Fleming highlights that three UK universities (University of Oxford, King\u2019s College London, and University College London) performed significantly better than the rest of Europe with regards to trial reporting, publishing 81\u201393% of results due.<\/p>\n<p>As a reminder to us all, he warns of the implications of failing to report clinical trial data by noting that \u201c<em>Campaigners say the resulting lack of transparency harms patients by undermining the efforts of doctors and health authorities to provide the best treatments, slows medical progress and wastes public funds<\/em>\u201d.<\/p>\n<div data-opinionstage-embed-url=\"https:\/\/www.opinionstage.com\/api\/v1\/polls\/2554947\/code.json?width=\" style=\"display: none; visibility: hidden;\"><\/div>\n<p>\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013<\/p>\n<p>Summary by\u00a0<a href=\"http:\/\/www.aspire-scientific.com\/#team_\">Emma Evans PhD, CMPP<\/a> from\u00a0<a href=\"http:\/\/www.aspire-scientific.com\/\">Aspire Scientific<\/a><\/p>\n<p>\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2014\u2013<\/p>\n<p>With thanks to our sponsors, <a href=\"http:\/\/www.aspire-scientific.com\/\">Aspire Scientific Ltd<\/a> and <a href=\"http:\/\/www.networkpharma.com\/\">NetworkPharma Ltd<\/a><\/p>\n<hr \/>\n","protected":false},"excerpt":{"rendered":"<p>A recent article from Nature news delves into clinical trial reporting following evidence showing that some universities are failing to meet EU regulations.<\/p>\n","protected":false},"author":1,"featured_media":5824,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"advanced_seo_description":"","jetpack_seo_html_title":"","jetpack_seo_noindex":false,"_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"Are European universities failing to report clinical trial data in a timely manner? 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