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GSK to publish all clinical trials data

Campaigners claim victory for doctors and patients

Mark Gould

Wednesday, 06 February 2013

After a lengthy period of lobbying Britain’s largest pharmaceutical company GlaxoSmithKline (GSK) has announced that it will back a campaign to publish all clinical trials data.

In a statement GSK said that it would sign up to the AllTrials campaign which is seeking the registration of all clinical trials, the reporting of all summary results and for full Clinical Study Results – the detailed findings – to be made public.

GSK says this will require retrieval and examination of each historic CSR to remove confidential patient information. Given the significant volume of studies involved, the company says it 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.

Campaigners including Ben Goldacre, the best-selling author of Bad Pharma, and Fiona Godlee, editor of the British Medical Journal and Sir Iain Chalmers, co-founder of the Cochrane Library, said it was a “cartwheel moment.”

Writing in The Independent today, Dr Goldacre said he had met Andrew Whitty, chief executive of GSK, last week. “It was clear they have spent a lot of time thinking about these issues. While I will always wait for proof of the pudding I do not believe this is mere lip service,” Dr Goldacre said.

“There is no serious defence for withholding information about clinical trials from doctors and patients. It is simply unethical and it harms patients," he added.

The AllTrials campaign has grown rapidly since publication of Bad Pharma four months ago, winning the backing of the Medical Research Council and the Wellcome Trust. GSK also said it intends to publish details of trials for all approved medicines dating back to its formation in 2000.

In the statement, Patrick Vallance, the president of the pharmaceuticals research and development division at GSK, 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.”

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