{"id":36027,"date":"2016-01-21T10:14:09","date_gmt":"2016-01-21T09:14:09","guid":{"rendered":"https:\/\/blogs.bmj.com\/bmj\/?p=36027"},"modified":"2016-01-22T11:36:12","modified_gmt":"2016-01-22T10:36:12","slug":"peter-doshi-roche-to-publicly-post-trial-protocols-just-kidding","status":"publish","type":"post","link":"https:\/\/blogs.bmj.com\/bmj\/2016\/01\/21\/peter-doshi-roche-to-publicly-post-trial-protocols-just-kidding\/","title":{"rendered":"Peter Doshi: Roche to publicly post trial protocols\u2014just kidding"},"content":{"rendered":"<p>\u201cThirdly, we will post the protocol of our trials as they are started and the results of trials once they are completed on two websites which are available to the public, clinicaltrials.gov and roche-trials.com.\u201d<\/p>\n<p><a href=\"http:\/\/www.roche.com\/research_and_development\/who_we_are_how_we_work\/clinical_trials\/our_commitment_to_data_sharing.htm?acc1=tab11\">So states Roche<\/a> in describing one element of its 2013 <a href=\"http:\/\/roche-trials.com\/pdf\/RocheGlobalDataSharingPolicy.pdf\">policy<\/a> on clinical trial data sharing.<\/p>\n<p>Such a policy would place the Swiss pharmaceutical company ahead of its peers, even GlaxoSmithKline, generally seen as the pharma leader in trial transparency.<\/p>\n<p>The only problem is that does not appear to be true.<!--more--><\/p>\n<p>I looked up two random studies on roche-trials.com: <a href=\"http:\/\/roche-trials.com\/trialDetailsGet.action?studyNumber=GO28888\">GO28888<\/a> (which Roche lists as currently recruiting participants) and <a href=\"http:\/\/roche-trials.com\/trialDetailsGet.action?studyNumber=GO28753\">GO28753<\/a> (which Roche says is \u201cactive, not recruiting\u201d). Both are oncology trials of unapproved, investigational drugs. Neither roche-trials.com webpage includes a link to the protocol.<\/p>\n<p>I wrote Roche, but they suggested I was looking in the wrong place and directed me to the US ClinicalTrials.gov and the EMA EUdraCT trial registries\u201d.<\/p>\n<p>This sounds fine, but there is one problem: the ClinicalTrials.gov website presently does not allow for the uploading and public posting of trial protocols; instead what appears is a structured summary of study details such as the purpose and eligibility criteria. (See the ClinicalTrials.gov entries for <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02273973\">GO28888<\/a> and <a href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01903993\">GO28753<\/a>). Nor are the documents available on the European Clinical Trials Register: <a href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/search?query=eudract_number:2013-000568-28\">GO28888<\/a> and <a href=\"https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2013-001142-34\/HU\">GO28753<\/a>.<\/p>\n<p>I asked Roche to clarify. They said I was correct.<\/p>\n<p>\u201cIt is correct that depending on the rules and regulations of the respective sites, protocols\/attachments cannot be uploaded. For the time being, protocols can therefore only be requested via this link,\u201d a spokesperson wrote, pointing me to <a href=\"http:\/\/www.roche.com\/research_and_development\/who_we_are_how_we_work\/clinical_trials\/our_commitment_to_data_sharing\/clinical_study_documents_request_form.htm\">Roche\u2019s online platform<\/a> for requesting access to clinical study data.<\/p>\n<p>I submitted a request for the two protocols, and received Roche\u2019s response a week later: sorry, but the documents are \u201cout of scope\u201d.<\/p>\n<p>\u201cUnfortunately, the documents that you requested have been deemed out of scope due to the fact that both studies are for non-marketed products for which we have not as yet received a Regulatory decision,\u201d stated the letter from global.data_sharing@roche.com.<\/p>\n<p>I had one last question for Roche: \u201cMay I ask whether there is any plan to make the protocols public? Or will they remain by request only, as now?\u201d<\/p>\n<p>Their response: \u201cAt this point in time, there are only plans to use the request link in order to make the protocols available.\u201d<\/p>\n<p>It is hard not to feel a bit of d\u00e9j\u00e0 vu here. In 2004, the New York State Attorney General\u2019s office settled its lawsuit against GlaxoSmithKline regarding consumer fraud related to the anti-depressant paroxetine. <a href=\"http:\/\/psychrights.org\/states\/NewYork\/NY-GSKConsentDecree.pdf\">In the settlement<\/a>, GSK agreed to publicly post the clinical study reports of its studies of paroxetine in adolescent and pediatric patients. But for eight years GSK neglected to post the appendices of these trial reports. When I asked for them in 2012, GSK refused. After I raised the point with the New York State Attorney General\u2019s office, the company posted an additional <a href=\"http:\/\/www.gsk.com\/en-gb\/media\/resource-centre\/paroxetine\/paroxetine-paediatric-and-adolescent-patients\/\">38,781 pages<\/a> \u2013 documents a RIAT team subsequently used to restore GSK\u2019s <a href=\"http:\/\/www.bmj.com\/content\/351\/bmj.h4629.full?ijkey=00ZjcBlMGct6aDR&amp;keytype=ref\">infamous<\/a> <a href=\"http:\/\/www.bmj.com\/content\/351\/bmj.h4320\">Study 329<\/a>.<\/p>\n<p>Between 2012 and 2014, <a href=\"http:\/\/www.gsk.com\/en-gb\/media\/press-releases\/2013\/gsk-announces-support-for-alltrials-campaign-for-clinical-data-transparency\/\">a wave<\/a> <a href=\"http:\/\/www.pfizer.com\/news\/press-release\/press-release-detail\/pfizer_expands_clinical_trial_data_access_policy_and_launches_data_access_portal\">of<\/a> <a href=\"http:\/\/www.phrma.org\/press-release\/EFPIA-and-phrma-release-joint-principles-for-responsible-clinical-trial-data-sharing-to-benefit-patients\">new<\/a> <a href=\"http:\/\/www.jnj.com\/news\/all\/johnson-and-johnson-announces-clinical-trial-data-sharing-agreement-with-yale-school-of-medicine\">transparency<\/a> <a href=\"https:\/\/www.bio.org\/articles\/bio-principles-clinical-trial-data-sharing\">policies<\/a> from industry seemed to usher in a <a href=\"http:\/\/circoutcomes.ahajournals.org\/content\/7\/4\/499\">new era<\/a> of data sharing. <a href=\"http:\/\/www.bmj.com\/content\/348\/bmj.g1615\">But I remain unconvinced that the policies are actually delivering on their promises<\/a>. It took AstraZeneca\u2014which announced its own \u201c<a href=\"https:\/\/www.astrazeneca.com\/our-company\/media-centre\/press-releases\/2015\/astrazeneca-scientific-review-board-clinical-trial-data-transparency-19032015.html\">transparency commitment<\/a>\u201d in 2015\u2014<a href=\"http:\/\/www.bmj.com\/content\/351\/bmj.h4169\">seven months<\/a> to inform me and colleagues at Johns Hopkins that it would not be providing us with clinical study reports or patient level datasets for use in our <a href=\"http:\/\/www.pcori.org\/research-results\/2013\/integrating-multiple-data-sources-meta-analysis-improve-patient-centered\">PCORI-funded study<\/a> of seroquel.<\/p>\n<p>Open data advocate Ben Goldacre often talks about the journey towards clinical trials transparency as one of many \u201c<a href=\"http:\/\/www.bmj.com\/content\/347\/bmj.f1880\">fake fixes,<\/a>\u201d false promises of change that actually did not sufficiently address the problems they pledged to fix. I think we can now add Roche\u2019s inaccessible protocols to that list.<br \/>\nCompeting interests: PD is 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>). This review focused on oseltamivir, manufactured by Roche, and zanamivir, manufactured by GSK. PD also received \u20ac1500 from the European Respiratory Society in support of his travel to the society\u2019s September 2012 annual congress in Vienna, where he gave an invited talk on oseltamivir. PD gratefully acknowledges the American Association of Colleges of Pharmacy for its funding support ($10 000) for a study to analyze written medical information regarding the possible harms of statins. AACP had no involvement in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of this manuscript.<\/p>\n<p><em><strong>Peter Doshi<\/strong>, associate editor, <\/em>The BMJ<em>.\u00a0<\/em><\/p>\n","protected":false},"excerpt":{"rendered":"<p>\u201cThirdly, we will post the protocol of our trials as they are started and the results of trials once they are completed on two websites which are available to the [&#8230;]<\/p>\n<p><a class=\"btn btn-secondary understrap-read-more-link\" href=\"https:\/\/blogs.bmj.com\/bmj\/2016\/01\/21\/peter-doshi-roche-to-publicly-post-trial-protocols-just-kidding\/\">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-36027","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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