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European Medicines Agency Tackles Transparency of Clinical Trial Data

By eCliniqua Staff 

December 7, 2012 | The European Medicines Agency held a workshop late last month on access to and transparency of clinical trial data. Their four-page report calls for proactive publication of clinical trial data. "It is no longer a question of if we start [sharing clinical trial data] but only of how we achieve it," said Hans-Georg Eichler, Senior Medical Officer of the European Medicines Agency. 

The Agency heard from representatives of academia, industry, the media, and patients. Representing academia, Peter Gøtzsche, director of the Nordic Cochrane Centre, part of the Cochrane Collaboration, expressed his concern that the current system allows the industry to be its own judge. He proposed public funding of drug development, if industry it too concerned about their intellectual property rights.  

Virginia Barbour, medicine editorial director, Chief Editor, PLoS Medicine, was one representative for the media and laid out clear goals for transparency "In terms of transparency, the short-term objective should be that all data used to support an application be made publicly available at the time of licensing. In the longer term, data from unsuccessful applications should also be made available. If we establish a vetting procedure for requests for data, then it should be a transparent one, where all requests are logged." 

Susan Forda, chair of EFPIA's Scientific, Regulatory and Manufacturing Policy Committee, and Vice President, International Regulatory Affairs at Eli Lilly and Company, emphasized that the issue of shared data is very sensitive. Industry would like to see data access reviewed on a case-by-case basis and with decision makers taking a range of factors into account, including the nature of the product, the data being presented, its place in its lifecycle and the method of release. "We also ask that the protection of intellectual property rights be fully considered," she said. 

At the end of the workshop, Eichler called for the formation of advisory groups to suggest policies that “the Agency can adopt or politely refuse” on the topics of clinical-trial-data formats; rules of engagement; good analysis practice; and the legal aspects. The proposed timeline calls for nomination for membership to begin immediately with advisory groups convening in January and February 2013. A final policy should come into force in January 2014.  

The EMA’s full report can be viewed here. [PDF] 

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