GlaxoSmithKline (GSK) has announced plans to set up a new online system that will enable researchers to access anonymous patient-level data from its clinical trials.
The announcement comes just days after the European Medicines Agency (EMA) finalised advice about a policy that would require proactive access to clinical trial data across the industry. The EMA’s policy is a response to the efforts of campaigners such as the British Medical Journal, the Cochrane Collaboration, and the epidemiologist Ben Goldacre who accuse pharma companies of selectively publishing only favourable clinical trial data in order to further their commercial interests.
After being landed with a record $3bn dollar fine, part of which was due to the misreporting of safety data from clinical trials of the antidepressant Paxil (paroxetine), GSK has made an effort to stay ahead of the curve when it comes to clinical trial transparency. They are so far the only company to sign up to the AllTrials campaign, which is committed to making all clinical trial data available to independent researchers at the level of the individual patient; this puts them at odds with the Pharmaceutical Research Manufacturers of America (PhRMA) who argued that releasing patient-level data would be “irresponsible with potentially harmful consequences for future medicine development.”
GSK will handle requests for data through a new section of its website (clinicalstudydata.gsk.com), with data being made available after a drug is approved or withdrawn from development. Importantly, the data will be accessible whether the study has been accepted for publication or not, and the database is expected to eventually date back to 2007. Researchers interested in accessing the data will have to submit a research proposal, which will be reviewed by an independent ‘third party.’ This independent body will be set up by an external panel appointed by GSK – the panel includes Brian Strom of the University of Pennsylvania, Marc Buyse of Hasselt University in Belgium, McGill University's Bartha Maria Knoppers and John Hughes of the UK Clinical Research Collaboration board.
Commenting on GSK’s proposals, Patrick Vallance, GSK's president of pharmaceuticals R&D stated that “when people volunteer for clinical trials they expect that the results will be used to help others. We are the first organisation to develop a system for sharing detailed clinical data in this way. Now we want to see this initiative transition to a broader independent model that brings together data from multiple organisations.”
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