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GSK signs up to AllTrials trial transparency campaign

Will publish formal clinical study reports for all of its medicines

GSK GlaxoSmithKline house

GlaxoSmithKline has signed up to the AllTrials campaign for clinical trial transparency, pledging to significantly extend the amount of study information it puts in the public domain.

The move makes GSK the first pharmaceutical company to throw its weight behind the campaign, putting it at odds with the public positions of several industry organisations, most notably PhRMA in the US.

It is also an important signal that the company wants to occupy the highground in the debate, while drawing a line under its past misdemeanors.

Last year GSK was hit by a record $3bn fine for, amongst other things, hiding safety information, while in 2010 it was accused of suppressing clinical data about its now-withdrawn diabetes drug Avandia

Patrick Vallance, president of pharmaceuticals R&D, said: “We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research.

“All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organisations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit.”

The company already posts summary information about each trial it begins, and the publicly available clinical trial register where this is held now includes around 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month.

But in announcing its support for AllTrials the company also promised to go even further and outlined plans to publish all its clinical study reports (CSRs).

These formal study reports form the basis for regulatory submissions to regulators such as the EMA and provide more details on the design, methods and results of clinical trials than the summaries GSK currently publicly discloses.

CSRs won't be made available until the medicines they relate to have been approved or discontinued from development and the results have been published. The company says this is necessary to allow the data to be reviewed by regulators and the scientific community first. GSK will also remove patient data from the CSRs and their appendices to ensure patient confidentiality is maintained.

GSK said it would also publish CSRs for clinical outcomes trials for all of its approved medicines, stretching back to the company's formation through the 2000 merger of Glaxo Wellcome and SmithKline Beecham.

It acknowledged there would be practical challenges in not only retrieving this number of records, but also removing confidential patient from them.

“Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines,” the firm said in a statement.

The move is a further extension to GSK data transparency project, which last year saw the firm pledge to make anonymised, patient-level data from its clinical trials available, on request, to researchers.

6th February 2013

From: Research

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