{"id":32473,"date":"2014-10-07T15:30:05","date_gmt":"2014-10-07T14:30:05","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=32473"},"modified":"2014-10-07T15:30:05","modified_gmt":"2014-10-07T14:30:05","slug":"tom-jefferson-emas-release-of-regulatory-data-trust-but-verify","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2014\/10\/07\/tom-jefferson-emas-release-of-regulatory-data-trust-but-verify\/","title":{"rendered":"Tom Jefferson: EMA&#8217;s release of regulatory data\u2014trust but verify"},"content":{"rendered":"<p>The European Medicines Agency (EMA) has <a href=\"http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Other\/2014\/10\/WC500174796.pdf\">now released the final version of its policy<\/a> on the prospective release of clinical reports of trials, which are\u00a0submitted by sponsors\u00a0to support\u00a0marketing authorisation applications (MAAs).\u00a0The agency has said that it will\u2014at a future date\u2014determine how to release individual participant data (IPD).<\/p>\n<p><strong>Scope<\/strong><br \/>\nThe policy\u2014to become effective from 1 January 2015\u2014explains what will be released and how. Full clinical study reports will not be released.\u00a0Rather, selected parts of clinical study reports will be released, including the \u201ccore report\u201d (although this is not labelled as such in the text), the\u00a0statistical analysis plan, protocol and its amendments, and a blank case report form. (To those familiar with clinical study reports, these are sections 1-15, 16.1.1, 16.1.2, and 16.1.9 of <a href=\"http:\/\/www.ich.org\/fileadmin\/Public_Web_Site\/ICH_Products\/Guidelines\/Efficacy\/E3\/E3_Guideline.pdf\">the ICH E3 guidelines<\/a>.)\u00a0The policy document does not explain why full\u00a0clinical study reports will not be released.<!--more--><\/p>\n<p><strong>Redactions<\/strong><br \/>\nThe EMA\u2019s policy states: \u201cThe Agency respects and will not divulge CCI [commercially confidential information]. In general, however, clinical data cannot be considered CCI.\u201d\u00a0 That said, commercially confidential information will be redacted, \u201cwhere disclosure may undermine the legitimate economic interest of the applicant\/market authorization holder\u201d and in\u00a0items\u00a0that may facilitate identification of trial participants. Sponsors will have primary responsibility for redacting study reports for EMA\u2019s approval prior to their being made accessible under the new policy.<\/p>\n<p><strong>Who gets access?<\/strong><br \/>\nTwo levels of access are described in the policy\u2019s terms of use (TOU). The first level will be accessed through a simple registration process and will be a view\u00a0on screen only mode. The second level (for academic and research use only) will require proof of identity in addition to the simple registration procedure. Users of this level will be able to download and save searchable clinical study reports. Both levels will be serviced by an electronic tool described as \u201cuser-friendly.\u201d In a second phase the\u00a0EMA plans to consult, and draft a policy, on access to IPD.<\/p>\n<p>The policy is a landmark, as for the first time it ensures access to clinical study reports of drugs\u00a0that have obtained a MAA or on which a decision has been made. The EMA may be the first regulator to allow such access and the Nordic Cochrane Centre, the European Ombudsman, and the EMA deserve credit for that.<\/p>\n<p>There&#8217;s a lot of good news for researchers\u00a0in the final version of the policy. Gone is the <a href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/06\/13\/tom-jefferson-and-peter-doshi-emas-double-u-turn-on-its-peeping-tom-policy-for-data-release\/\">\u201cPeeping Tom\u201d clause<\/a> of &#8220;viewing only&#8221; access to data\u2014described by users of comparable policies as \u201cscience through a periscope\u201d\u2014and there is no trace of a threat of legal proceedings for those who produce research that is disagreeable to sponsors.<\/p>\n<p>Peeping will be\u00a0limited to first level users, possibly mostly members of the public (who may not be able to make sense of such vast and complex documents through a periscope).<\/p>\n<p>Users of the data (academics and researchers) are encouraged to provide the EMA with a copy of their secondary analysis\u00a0before publishing it. This is a welcome softening of the requirement from previous drafts, which appeared to give the\u00a0EMA the right of veto on the release of any analyses. However, the motivation given for providing a copy (so that we can\u00a0alert the EMA of any cases in which re-analysis may change conclusions\u00a0and enable action to be taken) does not resonate with me. My review group has shown that <a href=\"http:\/\/www.bmj.com\/tamiflu\/ema\">the clinical study report evidence on oseltamivir in EMA\u2019s possession did not support some of the drug\u2019s approved indications<\/a>, but no action has been taken so far.<\/p>\n<p>The levels of redaction may also prove to be a hindrance to interpretation of the data by second level users.\u00a0My review\u00a0group has recently been the\u00a0recipient of clinical study reports in which redactions impeded interpretation of a potential serious harms narrative.<\/p>\n<p>The vagueness of exactly which parts of clinical study reports will be released is also worrying, as the main purpose of using regulatory data in research synthesis is to minimise the effects of reporting bias. It is possible that from now on clinical study reports will be written and structured in such a way as\u00a0to withhold vital details of a pharmaceutical drug\u2019s effects or present them in the best possible light\u2014mirroring the unreliability\u00a0of trial results published in journals (in their potential to\u00a0be affected by\u00a0reporting bias).<\/p>\n<p>Finally, there&#8217;s\u00a0a restrictive clause that requires non-European residents to have a proxy place of address in the European Union. The clause (which affects most of humanity) may prove a nice little earner for entrepreneurial organisations willing to provide an electronic abode.<\/p>\n<p>In <a href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/06\/13\/tom-jefferson-and-peter-doshi-emas-double-u-turn-on-its-peeping-tom-policy-for-data-release\/\">a previous post <\/a>I urged users to\u00a0adopt Reagan\u2019s maxim of \u201ctrust but verify\u201d when reading the EMA&#8217;s policies. Ultimately, we will not know how usable and transparent this policy is until it has been in use for some time.<\/p>\n<p><em><strong>Tom Jefferson<\/strong>, reviewer, Cochrane Acute Respiratory Infections Group, 00187, Roma, Italy<\/em>.<\/p>\n<p>Acknowledgements: Peter Doshi.<\/p>\n<p>Competing interests: TJ was a co-recipient of a UK National Institute for Health Research grant (HTA \u2013 10\/80\/01 Update and amalgamation of two Cochrane Reviews: neuraminidase inhibitors for preventing and treating influenza in healthy adults and children\u2014<a href=\"http:\/\/www.nets.nihr.ac.uk\/projects\/hta\/108001\">http:\/\/www.nets.nihr.ac.uk\/projects\/hta\/108001<\/a>).<br \/>\nIn addition: TJ receives royalties from his books published by Blackwells and Il Pensiero Scientifico Editore, Rome. TJ is occasionally interviewed by market research companies for anonymous interviews about Phase 1 or 2 pharmaceutical products. In 2011-2013, TJ acted as an expert witness in a litigation case related to oseltamivir phosphate; Tamiflu [Roche] and in a labour case on influenza vaccines in healthcare workers in Canada. In 1997-99 TJ acted as consultant for Roche, in 2001-2 for GSK, and in 2003 for Sanofi-Synthelabo for pleconaril (an anti-rhinoviral which did not get approval from the FDA). TJ was a consultant for IMS Health in 2013, and in 2014 was retained as a scientific adviser to a legal team acting on the drug Tamiflu (oseltamivir, Roche).<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The European Medicines Agency (EMA) has now released the final version of its policy on the prospective release of clinical reports of trials, which are\u00a0submitted by sponsors\u00a0to support\u00a0marketing authorisation applications [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2014\/10\/07\/tom-jefferson-emas-release-of-regulatory-data-trust-but-verify\/\">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":[5744],"tags":[],"class_list":["post-32473","post","type-post","status-publish","format-standard","hentry","category-open-data"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.5 - 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