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\nEMA wrangles restrain trial data progress<\/a><\/div>\nChemistryWorld<\/font><\/strong><\/div>\nby Andy Extance<\/div>\n3 July 2014<\/div>\nTempers are being tested as the pharmaceutical industry’s journey towards transparency on clinical trial data enters a critical phase. Even as drug companies announce more voluntary access schemes, campaign group AllTrials<\/a> has accused the European Medical Agency<\/a> [EMA] of a ‘backroom deal with pharma’ to weaken earlier commitments. The disputes have arisen following EMA consultations over its clinical trial data policy, which it hopes to finalise in mid-July, and bring into force in October. The pioneering plan would be the first of its kind to proactively publish clinical trial reports, giving people access for non-commercial use without needing to request it from companies. After receiving over 1100 comments covering a broad spectrum of opinions<\/a>, the EMA conducted follow-up meetings in May to discuss the resulting proposals. Following the meetings researchers<\/a>, AllTrials<\/a>, and even the EU Ombudsman<\/a> reacted critically.<\/p>\n
The chief concern was a ban on saving, downloading or printing clinical study reports [CSRs], making these huge documents available only on-screen. The Institute for Quality and Efficiency in Health Care [IQWiG<\/a>], Germany’s national commission for assessing medical procedures, was especially outraged. It took to Twitter with a long series of photos<\/a> underlining how hard this would make its job. The same groups also warned that the new ‘terms of use’ contract could let trial sponsors sue researchers, creating a legal chill that would deter scrutiny.<\/div>\n<\/blockquote>\nI’m particularly glad there was such widespread outrage about their "screen only" proposed interface. Having used such a system for the last months, I was afraid that people wouldn’t realize what a hinderance that really is. Our analogy of going to sea to see the world in a submarine looking through a periscope was no exaggeration.<\/div>\n\nThe EMA’s new redaction policy on what information could be hidden drew fire too. It arose because of comments in the initial consultation that patient privacy, trust in the system, and commercial confidentiality could be put at risk. Richard Bergstrom, director general of the European Federation of Pharmaceutical Industries and Associations [EFPIA], expressed worry over ‘putting transparency – at whatever cost – ahead of public health interests’.<\/div>\n<\/p>\n
The proposed EMA policy allows drugmakers to propose redactions for text they feel is commercially or otherwise sensitive, although the regulator will retain the final say on what is hidden. Campaigners say this measure and vague policy wording will mean too much is concealed. EMA spokesman Martin Harvey-Allchurch stresses that ‘third parties’ can petition or sue if they think that’s happening, and that the extent of redaction will always be visible<\/font><\/strong>.<\/div>\n<\/blockquote>\nI hadn’t read that red part elsewhere, but that’s a reasonable request if the process of petitioning is clear. That last part ["the extent of redaction will always be visible<\/font>"] is reassuring. I’d prefer that there be no redaction clause at all. What business is Commercially Sensitive Information of the European Medical Agency anyway? But one can’t expect to win every battle.<\/div>\n\nWorking too closely?<\/font><\/strong><\/div>\nYet the new policy still seemed to many a significant departure from the EMA’s previous hard line on data disclosure. Its 2010 ‘access to documents’<\/a> policy considers that most CSRs are not commercially confidential information, and promised to disclose CSRs for every drug it had reviewed. The confidentiality point has drawn fire from some drugmakers, with AbbVie and InterMune<\/a> disputing it in court. But in April, AbbVie dropped its case, the day after the EU passed regulations that will make clinical trial registration and data sharing a legal requirement. Then, at the end of May, InterMune dropped some of its cases against the EMA.<\/p>\n
AllTrials subsequently suggested that the price for dropping the cases had been a more industry-favourable transparency policy, something Harvey-Allchurch ‘absolutely refutes’. ‘AbbVie realised that we’re going to stick with our definition of commercial confidentiality – they knew they were not going to win that one,’ he says. ‘They went away, and came back with proposals for what they wanted redacted. In the end, what they proposed was in line with our redaction principles. The main InterMune case is still running.’<\/p>\n
Following the pressure over its proposals on 12 June, the EMA’s management board agreed an amended policy<\/a>. That allows downloading, saving and printing trial data for academic and non-commercial research purposes, although the other controversial areas remain unchanged. Nevertheless Harvey-Allchurch plays down the outcry surrounding the new policy. ‘The whole purpose of these targeted consultation exercises was to listen,’ he says. ‘We heard the feedback, we listened to it, and proposed an alternative to the board.’ But with Harvey-Allchurch underlining that this policy initiative is a bridge to the new EU regulations that will come in some time after May 2016, the final policy wording will be highly significant.<\/div>\n<\/blockquote>\nI don’t believe what PHARMA says anymore. That was actually a conscious decision on my part. I made it the day I read GSK’s response in the Chronicle of Higher Education denying an agreement they’d just signed [see the only enduring contract…<\/a>]. Life has been easier not having to obsess about what to trust. I’d suggest it to all as a general strategy. To stick to my penchant for old sayings: "The best predictor of future behavior is past behavior.<\/em>" <\/div>\n\nIndustry delivers<\/font><\/strong><\/div>\nMeanwhile, pharma companies continue to progress their own schemes to make data available, with Bristol-Myers-Squibb [BMS] becoming the latest to open up its trial results. The Duke Clinical Research Institute<\/a> at Duke University in Durham, North Carolina will act as the gatekeeper for BMS’ data. It will review study proposals and check final manuscripts ‘for scientific integrity and consistency with the original proposed work’ like Yale is doing for Johnson & Johnson<\/a>. Boehringer-Ingelheim has also said that it will publish documents for all approved products going back to 1998. That move goes beyond the ‘Principles for responsible clinical trial data sharing’ introduced by the EFPIA and the Pharmaceutical Research and Manufacturers of America [PhRMA] last July.<\/p>\n
IQWiG spokesperson Susanne Breuer highlights that a fragmented landscape of company data repositories would be less desirable than the single repository the EMA hosts. ‘The control of data completeness would be much more complicated, and analysing data it would take a lot longer,’ she says. ‘We would appreciate centralised access for scientists.’ Parts of the industry are making progress here, with Eli Lilly and Bayer Healthcare agreeing to make trial data available via Clinicalstudydatarequest.com<\/a>. They bring the number of companies using the portal, created by GlaxoSmithKline last year, to eight.<\/div>\n<\/blockquote>\nI’m on a team looking at the data from a questionable study, and except for the maddening "screen only" interface, I feel comfortable with the access we have to the information we wanted to see. I hasten to add that there was a good deal of negotiating involved in getting it. I think I would be more accepting of these recent examples of industry delivering<\/em> if they had given in much earlier. I’m suspicious of foxhole conversions and that’s what this is. And there’s really no need for PHARMA to maintain that kind of control. In the end, we really should be privy to everything that goes to the regulatory agencies. That’s also true for all Clinical Trials, but that’s another part of the fight… <\/div>\n","protected":false},"excerpt":{"rendered":"Though ChemistryWorld is not one of my usual sites, I give them credit for one fine summary of the current state of the European Medicines Agency Data Transparency story: EMA wrangles restrain trial data progress ChemistryWorld by Andy Extance 3 July 2014 Tempers are being tested as the pharmaceutical industry’s journey towards transparency on clinical […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[2],"tags":[],"class_list":["post-47895","post","type-post","status-publish","format-standard","hentry","category-politics"],"_links":{"self":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47895","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/comments?post=47895"}],"version-history":[{"count":14,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47895\/revisions"}],"predecessor-version":[{"id":47909,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/posts\/47895\/revisions\/47909"}],"wp:attachment":[{"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/media?parent=47895"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/categories?post=47895"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/1boringoldman.com\/index.php\/wp-json\/wp\/v2\/tags?post=47895"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}