EMA Makes Clinical Trial Data Available

EMA Makes Clinical Trial Data Available

July 17th, 2012 // 12:25 pm @

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After being harshly criticized for refusing to release clinical trial data, the European Medicines Agency plans to hold a conference in November to review different ways that large sets of data could be made available quickly and regularly to outside researchers, Reuters writes. “It’s a sea change in attitude,” EMA senior medical officer Hans-Georg Eichler tells the news service.

The move signifies a new chapter in the battle over access to clinical trial data, an issue that has intensified in recent years in the wake of several scandals, such as the availability of information surrounding the Vioxx painkiller that was withdrawn by Merck and the Avandia diabetes pill sold by GlaxoSmithKline. The decision by the EMA to review access may also add pressure on the FDA to take a similar step.

“This announcement by the European Medicines Agency is historic, because it marks an irreversible commitment to sharing all the data it receives for the purposes of drug and device licensing. Previous aspirational statements along these lines have been encouraging, but their intention to convene a conference shows that they are committed to practical action,” wrote Richard Lehman, a Department of Primary Care professor at the University of Oxford and author of the Journal Watch blog, on a Google forum in response to the news.

The about face by the EMA comes after criticism from the European Ombudsman for withholding data (look here) and a prolonged battle over trial data for the Tamiflu influenza med that is sold by Roche. Researchers at the Cochrane Collaboration attempted to review efficacy data in response to concerns that regulators did not see all of the pertinent data and faulty assumptions were made by public health officials in promoting the drug to prevent outbreaks.

But despite reassurances from the drugmaker, the researchers were not provided all of the promised study data. And the tussle became a widely publicized symbol over the virtues of releasing such data publicly. A debate emerged last April in PLoS Medicine, where the Cochrane team argued that regulators and drugmakers should adopt a policy of releasing both industry-sponsored studies and regulatory evaluations in the interest of improving and maintaining public health.

In response, regulators from the European Medicines Agency, as well as France, the UK and the Netherlands wrote that they agree, but only up to a point. They acknowledged that clinical trial data should not be considered commercial confidential information, a failure to disclose undermines the greater good and that releasing raw data sets can lead to improved drug development. But they also issued some caveats, such concerns over as patient confidentiality (back story).

Now, though, the EMA appears to be having a change of heart. “This industry has certainly done a disservice to itself,” Eichler tells Reuters. “I hope everybody will learn that daylight is the best disinfectant and this will be a contributing step in rebuilding trust in the regulator and in the industry.” We asked the EMA for details about the November conference and will update you accordingly.

Glaxo, for instance, recently paid a $3 billion settlement, in part, due to its failure to report safety data about the Avandia diabetes pill to the FDA (read here). And Merck was excoriated for its handling of data relating to cardiovascular risks associated with Vioxx; last week, a new paper suggested Merck hid evidence that Vioxx tripled the risk of cardiovascular death for more than three years before taking the pill off the market in 2004


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