{"id":4372,"date":"2010-09-20T16:59:05","date_gmt":"2010-09-20T15:59:05","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=4372"},"modified":"2010-10-08T13:50:30","modified_gmt":"2010-10-08T12:50:30","slug":"wim-weber-on-independent-clinical-research-in-europe","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2010\/09\/20\/wim-weber-on-independent-clinical-research-in-europe\/","title":{"rendered":"Wim Weber on independent clinical research in Europe"},"content":{"rendered":"<p><img loading=\"lazy\" decoding=\"async\" class=\"alignleft\" style=\"float: left\" src=\"http:\/\/www.bmj.com\/columns\/icons\/wim_weber.jpg\" alt=\"Wim Weber\" width=\"160\" height=\"160\" \/> Earlier this month the workshop on the \u201cFuture of Independent Academic Clinical research in Europe\u201d took place in the\u00a0<a title=\"Academic Royale\" href=\"http:\/\/www.armb.be\/\" target=\"_blank\">Acad\u00e9mie royale de m\u00e9decine de\u00a0Belgique<\/a>,\u00a0housed in a palace neighbouring King Albert\u2019s\u00a0 in Brussels.<\/p>\n<p>Greeting you at the entrance is a statue of the Belgian mathematician <a title=\"Adolphe Quetelet\" href=\"http:\/\/en.wikipedia.org\/wiki\/Adolphe_Quetelet\" target=\"_blank\">Adolphe Quetelet <\/a>(he of the index), but entering is hampered by scaffolding, lorries, and builders. The palace, built in 1823, is presently being renovated. This was a fitting ambience for the workshop, because there is another European monument in urgent need of restructuring: independent clinical research.<!--more--><\/p>\n<p>What is the problem? Lack of funding and bureaucracy, say the organisers. <a title=\"Francoise Meunier\" href=\"http:\/\/en.wikipedia.org\/wiki\/Fran%C3%A7oise_Meunier\" target=\"_blank\">Fran\u00e7oise Meunier<\/a>, director of the <a title=\"EORTC\" href=\"http:\/\/www.eortc.be\/\" target=\"_blank\">European Organisation for Research and Treatment of Cancer<\/a> (EORTC), organised the meeting to put the problem on the agenda of the European Commission (Belgium is now chairing the EU).<\/p>\n<p>Liselotte H\u00f8jgaard, nuclear medicine specialist from Copenhagen, and currently chair of the <a title=\"European Medical Research Councils\" href=\"http:\/\/www.esf.org\/home.html\" target=\"_blank\">European Medical Research Councils<\/a>, told\u00a0the\u00a0conference:\u00a0\u00a0&#8220;The USA spends three times as much as Europe on medical research, with the NIH alone already giving out 40 billion dollars a year.&#8221;\u00a0 She urged politicians to allocate more European research money into clinical research, citing the 2008 <a title=\"Wellcome Trust\" href=\"http:\/\/www.wellcome.ac.uk\/About-us\/Publications\/Reports\/Biomedical-science\/WTX052113.htm\" target=\"_blank\">Wellcome Trust <\/a>report, that calculated a return on investment of medical research of 39%. &#8220;Where else can you get that percentage on your invested money?&#8221; she asked.<\/p>\n<p>This was illustrated by Martine Piccart, a Brussels-based oncologist, who told the story of funding for a major breast cancer trial with 6000 patients: &#8220;After years of haggling for money within Europe, we were at last able to do the trial because the American NIH gave us $20m.&#8221;<\/p>\n<p>Bureaucracy raises even more emotions. Francoise Meunier gave the example of the pregnant principal investigator: &#8220;When the PI is expecting, this constitutes a major amendment according to the EU guidelines, and it involves major paperwork and major delays.&#8221;<\/p>\n<p>Surely, all the guidelines are there to protect the patients, but we learned from one of them that lack of information, not lack of guidelines, is the main obstacle to taking part in clinical trials. Kathy Oliver, of the <a title=\"IBTA\" href=\"http:\/\/www.theibta.org\/\" target=\"_blank\">International Brain Tumour Alliance<\/a> in the UK, showed us that participation rates in UK cancer trials are more than double the rates in the rest of the world: &#8220;Patient involvement in the early design of clinical trials is crucial\u2026&#8221;<\/p>\n<p>This was echoed by a clinical researcher in the audience, who said: &#8220;Most ethics committees do not understand the research, so they spend their energy on the patient information section; the result is that these sections end up being 4-5 pages long and completely unintelligible to patients.&#8221;<\/p>\n<p>Is clinical research really endangered in Europe ? Stefan F\u00fchring of the EU directorate general for Health and Consumers, showed us that this is indeed so. He said: &#8220;The number of clinical trial applications has fallen from 5028 in 2007 to 4491 in 2009, and, even more alarmingly, the number of patients taking part in them has fallen from 535481 to 35829.&#8221; His directorate is currently revising the <a title=\"EU trial guidelines\" href=\"http:\/\/ec.europa.eu\/health\/human-use\/clinical-trials\/index_en.htm\" target=\"_blank\">EU trial guidelines<\/a>, that were drawn up in 2001. He welcomes any suggestions.<\/p>\n<p>Well, better late than never. He might want to have a look at the 31 July 2004 issue of the <a title=\"BMJ\" href=\"http:\/\/www.bmj.com\/content\/329\/7460\/0.8.full\" target=\"_blank\"><em>BMJ<\/em><\/a>, that includes, according to Richard\u00a0Smith&#8217;s editor&#8217;s choice, a &#8220;series of Kafkaesque experiences with ethics committees that have made research difficult or impossible.&#8221;<\/p>\n<p><strong>Wim Weber<\/strong> is the European research editor, <em>BMJ<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Earlier this month the workshop on the \u201cFuture of Independent Academic Clinical research in Europe\u201d took place in the\u00a0Acad\u00e9mie royale de m\u00e9decine de\u00a0Belgique,\u00a0housed in a palace neighbouring King Albert\u2019s\u00a0 in [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2010\/09\/20\/wim-weber-on-independent-clinical-research-in-europe\/\">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-4372","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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