{"id":22545,"date":"2012-11-23T18:07:44","date_gmt":"2012-11-23T17:07:44","guid":{"rendered":"http:\/\/stg-blogs.bmj.com\/bmj\/?p=22545"},"modified":"2012-11-26T17:44:58","modified_gmt":"2012-11-26T16:44:58","slug":"trish-groves-a-european-tale-data-sharing-at-the-ema","status":"publish","type":"post","link":"https:\/\/stg-blogs.bmj.com\/bmj\/2012\/11\/23\/trish-groves-a-european-tale-data-sharing-at-the-ema\/","title":{"rendered":"Trish Groves: A European tale\u2014data sharing at the EMA"},"content":{"rendered":"

\"\"<\/a>This is a tale of extraordinary persistence by medical researchers\u2014particularly those at the Nordic Cochrane Centre in Copenhagen\u2014on behalf of patients. And it seems to have a happy ending.<\/p>\n

It starts in the warmer climes of Rome and Lisbon, where treaties were signed to form the constitutional basis of the European Union<\/a>. These treaties laid out the principle that all documents of EU institutions and agencies should be accessible to the public. But in 2010, just a few months after the Lisbon treaty was enacted, the European Medicines Agency (EMA) argued against disclosing full data from the clinical trials that underpinned its approval of medicines. There were four reasons to block public disclosure, said the agency: preparing the datasets would take an inordinate amount of effort; it would infringe data protection rights; it would scupper intellectual property rights as defined in the World Trade Organization\u2019s TRIPs agreement<\/a>; and it would damage the drug industry\u2019s commercial interests.<\/p>\n

The Nordic Cochrane group, who had applied unsuccessfully in 2007 for access to specific clinical trial data, made one of two key complaints to the EU ombudsman. In late 2010 the ombudsman ruled that EMA should disclose the requested data<\/a>, because \u201cEMA has not established that the requested documents fall within the scope of the commercial interests exception, as provided for in the Rules. It follows that their disclosure cannot undermine commercial interests. Even if one were to assume that certain information contained in the requested documents could fall within the scope of the commercial interests exception, there appears to be nothing to suggest that disclosure would specifically and actually undermine commercial interests.\u201d Moreover, the ombudsman decided that it wouldn\u2019t be too burdensome to disclose the data and that the dataset was well enough anonymised.<\/p>\n

No sooner said than done. Indeed, the EMA swiftly released a new policy<\/a> confirming the rights of EU citizens\u2019 to have the widest possible access to the agency\u2019s documents, and agreeing to grant access on written request. So far, so good. But what about public access to the data? That would come, said EMA, within three years.<\/p>\n

And now we\u2019re nearly there. At a hugely oversubscribed workshop on 22 November 2012<\/a> at the EMA\u2019s windswept HQ in London\u2019s Canary Wharf, the agency sought views on what it should do.<\/p>\n

The workshop started well. \u201cWe are not here to decide if we publish clinical trial data, but how\u201d, said Guido Rasi, EMA\u2019s Executive Director, making at least one of the sceptical panellists hurriedly rewrite a script that pleaded for data release. And then the agency gave Peter G\u00f8tzsche of the Nordic Cochrane Centre his rightful place as the first invited speaker.<\/p>\n

Yet Peter and the other five panellists got only 5 minutes each, and were marshalled tightly by moderator Sir Mark Walport. The ensuing panel discussion and questions from the invited audience covered all the right topics: patients\u2019 needs for full information balanced against research particpants\u2019 rights to privacy, the needs of systematic reviewers and clinicians for the full evidence on the benefits and harms of drugs, and the technical and legal challenges of sharing the data. But it was a procession of comments rather a debate, none of it was covered in depth, and the EMA, meanwhile, said not a word.<\/p>\n

That\u2019s not to say the contributions weren\u2019t important or interesting, and the several tweeters – including panellists @GinnyBarbour of PLoS and @BenGoldacre – captured all its wisdom and at times, wit, at #ctdata. In case you want to relive it, I\u2019ve Storified it here<\/a> and the EMA\u2019s live webcast will soon be archived at http:\/\/www.ema.europa.eu\/ema\/. Two Top Tweets summed it up for me:<\/p>\n

Ben Goldacre @BenGoldacre<\/a>: David Healy: \u201cDo patients consent to their data being shared? Better to ask: do they consent to it being hidden?\u201d<\/p>\n

Andrew Jack @AJack<\/a>: Who would have thought it? Clinical trials transparency vies with Thanksgiving Turkey as top Twitter trender<\/p>\n

And then, as we were losing hope, came the happy ending. To a collective gasp from the audience (I\u2019m not exaggerating\u2014we really didn\u2019t expect it), EMA\u2019s senior medical officer Hans-Georg Eichler announced in the closing minutes that the agency would start to share clinical trial data publicly<\/a> from January 2014. They\u2019ve a lot to do in the meantime, including taking evidence from five advisory groups and the public.<\/p>\n

Epilogue: nobody in the audience seemed sure whether this public data release will apply retrospectively, to the thousands of trials that underpin the treatments patients are taking now. It’s those retrospective data that we all need. Still, EMA did state very clearly at the workshop that those data will continue to be released on written request, under its 2010 policy.<\/p>\n

Trish Groves<\/strong> is deputy editor<\/em>, BMJ.<\/p>\n

See also:<\/p>\n