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GSK promises to publish detailed drug trial data

Tue, 05th Feb 2013 15:34

* UK drugmaker paid $3 bln last year to settle fraud case

* Company criticised for keeping medicine data secret

* Will publish detailed clinical study reports

* Historical data back to 2000 will also be revealed

LONDON, Feb 5 (Reuters) - British drugmaker GlaxoSmithKline, which paid $3 billion last year to settle charges thatit gave misleading information on its medicines, said on Tuesdayit would publish more of its clinical research data.

When the company agreed to the fines last July, governmentofficials called it the largest healthcare fraud case in U.S.history, involving Glaxo drugs such as the antidepressant Paxiland diabetes pill Avandia.

Other firms have also reached settlement deals and theindustry has come under growing pressure from campaign groups torelease all their clinical trial data.

GSK said it would publish the results of clinical studyreports (CSRs) and clinical trials, showing its commitment totransparency.

The company already promised in October 2012 to make datafrom its clinical trials available to other researchers. Thiswould include patient-level results that sit behind trials ofapproved and failed drugs.

"Expanding on this, GSK is committing to make CSRs publiclyavailable through its clinical trials register," the companysaid in a statement.

CSRs are formal study reports that provide more detail onthe design, methods and results of clinical trials and form thebasis of submissions to regulators such as the United StatesFood and Drug Administration and European Medicines Agency.

The drugmaker said that it would now publish CSRs for allits medicines once they are approved or discontinued fromdevelopment. This would allow for the data to be first reviewedby regulators and the scientific community, it said. Patientdata will be removed to ensure confidentiality.

Patrick Vallance, GSK's president of pharmaceuticalsresearch and development, said the promises were aimed athelping "advance scientific understanding and inform medicaljudgment".

"Our commitment also acknowledges the very greatcontribution made by the individuals who participate in clinicalresearch," he said in the statement.

In an apparent effort to put its past record straight, GSKalso said it intends to publish CSRs for clinical outcomestrials for all approved medicines dating back to the formationof the company in 2000.

It said this would take time and resources as it wouldrequire retrieval and examination of each historic CSR to removeconfidential patient information.

"Given the significant volume of studies involved, thecompany will put in place a dedicated team to conduct this workwhich it expects to complete over a number of years," it said.

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