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GSK to set up online system for trial data requests

Pharma company fleshes out transparency plans

GSK to set up online system for trial data requests

GlaxoSmithKline (GSK) has said it plans to set up a new online system that will allow researchers to request anonymous patient-level data from its clinical trials.

The move comes in response to increasingly strident calls for greater transparency in the pharmaceutical industry, which has long been criticised for selectively reporting clinical trial data in the name of protecting commercial interests.

After being hit by a record $3bn fine in 2012 - in part because of misreporting of clinical data on antidepressant Paxil (paroxetine) - GSK seems to be trying to take the lead on transparency among its big pharma peers.

The company was the first to sign up to the AllTrials campaign - putting it at odds with industry organisations such as PhRMA in the US - but has arguably gone even further with its new initiative.

A new section on its website ( will handle requests for data, with researchers expected to submit a scientific protocol for their research and commit to publishing the findings.

The data would be made available after a drug is approved or withdrawn from development – crucially whether the study has been accepted for publication or not – and the database will eventually date back to 2007, said GSK.

The workings of the system will be set up with the help of an external panel appointed by GSK, according to the drug company, which also suggested that it would like to expand the scheme into a broader platform that would include trial data from multiple organisations.

Members of the panel include 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.

Down the line, the panel will help set up an independent 'third party' that would review researchers' requests for data access.

Commenting on the proposals, Patrick Vallance, GSK's president of pharmaceuticals R&D, said: "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," he added.

Roche still under fire
Earlier this year, Roche made a similar announcement about expanding access to trial data after being roundly criticised in a number of quarters for allegedly withholding clinical data on the effectiveness of its flu drug Tamiflu (oseltamivir).

One of the staunchest critics, Peter Gøtzsche of the Nordic Cochrane Centre, has reiterated criticism of the pharma company in the British Medical Journal (BMJ), saying the company continues to withhold data on Tamiflu despite promising to make it available four years ago.

In the rapid response, Gøtzsche claims that Roche's position that it needs to edit the data to preserve patient confidentiality and commercial interests is "smoke and mirrors".

"According to EU law, companies are obliged to ensure patient confidentiality in their clinical study reports," he writes.

Meanwhile, "the idea of needing to edit the reports to protect legitimate commercial interests is also a red herring", according to Gøtzsche, who cites earlier requests by the Cochrane Centre for data on Roche obesity drugs which were subsequently inspected by an EU ombudsman and found to contain no commercially-sensitive information.

8th May 2013

From: Research, Regulatory



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