{"id":32442,"date":"2014-10-02T12:30:24","date_gmt":"2014-10-02T11:30:24","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=32442"},"modified":"2014-10-29T12:37:28","modified_gmt":"2014-10-29T11:37:28","slug":"wim-weber-eu-seminar-on-access-to-trial-data","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2014\/10\/02\/wim-weber-eu-seminar-on-access-to-trial-data\/","title":{"rendered":"Wim Weber: EU seminar on access to trial data"},"content":{"rendered":"<p><a href=\"https:\/\/blogs.bmj.com\/bmj\/2013\/05\/29\/wim-weber-on-open-the-european-research-project-to-study-publication-bias\/wim_weber\/\" rel=\"attachment wp-att-26736\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft size-full wp-image-26736\" src=\"https:\/\/blogs.bmj.com\/bmj\/files\/2013\/05\/wim_weber.jpg\" alt=\"wim_weber\" width=\"160\" height=\"160\" srcset=\"https:\/\/blogs.bmj.com\/bmj\/files\/2013\/05\/wim_weber.jpg 160w, https:\/\/blogs.bmj.com\/bmj\/files\/2013\/05\/wim_weber-150x150.jpg 150w\" sizes=\"auto, (max-width: 160px) 100vw, 160px\" \/><\/a>On 29 September, more than 150 delegates showed up to attend the \u201c<a href=\"http:\/\/www.ombudsman.europa.eu\/en\/activities\/calendarevent.faces\/en\/864\/html.bookmark\">Transparency and public health<\/a>\u201d seminar, organised by the European ombudsman and held at the European Parliament in Brussels, Belgium.<\/p>\n<p>This \u201cInternational Right to Know Day\u201d is an annual event organised by the ombudsman, and newly appointed Emily O\u2019Reilly from Ireland chose accessibility of clinical trial data as the theme for this year\u2019s event.<!--more--><\/p>\n<p>Panel members were Ben Goldacre, who was seated at one side of the table, and, on the other side, was his main opponent, Richard Bergstr\u00f6m, director of the European Federation of Pharmaceutical Industries and Associations. Between those two were Guido Rasi, director of the European Medicines Agency; Margrete Auken, member of the European Parliament and shadow rapporteur for clinical trials regulation; and Emily O\u2019Reilly, European ombuds(wo)man. Moderating the discussion was Fr\u00e9d\u00e9ric Simon, editor of <em>EurActiv<\/em>.<\/p>\n<p>Viewpoints were as expected: Goldacre, Auken, and O\u2019Reilly arguing for total transparency and availability of all data for interested researchers to analyse; Bergstr\u00f6m stressing issues of patient privacy and commercial interests as possible obstacles\u2014with Rasi somewhat caught in the middle.<\/p>\n<p>Some interesting points emerged. Rasi told us that he expects the EMA\u2019s management board to approve this week the new proposal allowing interested researchers access to all clinical data, with the possibility to download these data. This is an important step from <a href=\"http:\/\/www.bmj.com\/content\/348\/bmj.g3561\">the\u00a0earlier proposal that allowed &#8220;screen only&#8221; views of the data<\/a>. He expects the first complete clinical study reports to be available in 2016.<\/p>\n<p>This is progress of course, but, as Goldacre pointed out, it still leaves us unclear about data from earlier trials, on which more than 90% of our present daily prescribing is based. He also made clear that the EMA can only work with the data they have. The EMA obviously has no data on off-label prescribed medicines, and thus researchers are entirely dependent on the goodwill of the pharmaceutical companies to give access to these data. Bergstr\u00f6m pointed out that at present about half of all companies in his association do comply with requests for old trial data, and the others are working on it. For Goldacre, Auken, and O\u2019Reilly this was not good enough, and Goldacre shared some of his personal experiences on the unwillingness of industry to share their data when asked for it.<\/p>\n<p>As for commercial interests as a possible obstacle, it emerged that this area is as yet undefined in legal terms. In the recent court case of <a href=\"http:\/\/www.bmj.com\/content\/348\/bmj.g2632\">biopharmaceutical company AbbVie suing the EMA<\/a> over its policy of data releasing, adverse events were argued to be commercially sensitive information.<\/p>\n<p>Patient privacy issues can be a problem, especially in very rare diseases, where patients might be easily identifiable from clinical data. Goldacre thought that confidentiality is a bad argument against sharing data, as researchers are bound by secrecy. He has a point here, as\u00a0up until now there have been few problems in this area, despite the massive amount of research going on.<\/p>\n<p>In Goldacre&#8217;s research he has even encountered companies refusing to show the consent forms that they claim forbid them to share patients\u2019 data.<\/p>\n<p>When asked about patient representatives, Emily O\u2019Reilly made an interesting point by answering: \u201cWe are all patients and potential patients.\u201d To me, this makes much sense, as I have often asked myself how representative patient representatives are. There are no patient associations for acute diseases and so patient representation tends to be biased towards chronic disorders.<\/p>\n<p>In summary, progress is still being made, but these are small steps and the <a href=\"http:\/\/www.alltrials.net\/\">AllTrials campaign<\/a> still has its work cut out for itself.<\/p>\n<p><em><strong>Wim Weber<\/strong>\u00a0is European research editor for <\/em>The BMJ<em>.\u00a0<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On 29 September, more than 150 delegates showed up to attend the \u201cTransparency and public health\u201d seminar, organised by the European ombudsman and held at the European Parliament in Brussels, [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/10\/02\/wim-weber-eu-seminar-on-access-to-trial-data\/\">More&#8230;<\/a><\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[116],"tags":[],"class_list":["post-32442","post","type-post","status-publish","format-standard","hentry","category-editors-at-large"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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