ZURICH (Reuters) - Swiss drugmaker Roche Holding has agreed to expand access to its clinical trial data as the pharmaceutical industry faces calls for greater transparency on scientific data.
The company's move follows a decision this month by British rival GlaxoSmithKline to publish detailed clinical study reports as well as the results of all drug trials.
Roche has also come under pressure from critics, including non-profit organization The Cochrane Collaboration, to hand over data on its blockbuster flu drug Tamiflu amid claims from researchers that there is little evidence it works.
The drugmaker said on Tuesday that it would work with an independent body to evaluate and approve requests to access anonymized patient data and would support the release of full clinical study reports (CSR) via regulatory authorities.
"We understand and support calls for our industry to be more transparent about clinical trial data with the aim of meeting the best interests of patients and medicine," Daniel O'Day, head of Roche's pharmaceuticals unit, said. (Ver)
De escépticos es no creer...
Zosia Kmietowiicz, en BMJ es un@ de ellos...
Campaigners for full transparency of all clinical trial data have responded with incredulity to a statement from the drug company Roche saying that it would continue to hold back certain information and results from research into its drugs.
Tracey Brown, director of the charity Sense About Science, said that the company was “on another planet.”
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Researchers from the Cochrane Collaboration have been waiting for three years for Roche to honour a promise it made in the BMJ in 2009 to give them access to full results from research on oseltamivir (Tamiflu) to establish the drug’s effectiveness and safety (bmj.com/tamiflu).
Last November they rejected an offer from Roche to allow an advisory board to review what type of analysis of data on oseltamivir would be useful to them, saying that they were waiting for the company to fulfil its promise to them.
The latest statement from Roche, issued on 26 February, said that the company would continue to vet requests for data that were not publicly available and would allow access only to those it approved.
It said that any information that was released through this channel “will be edited in consultation with Roche to ensure patient confidentiality and to protect legitimate commercial interests, including intellectual property rights.”
Brown described Roche’s response to the campaign for transparency as “poor,” adding “Which bit of ‘all’ and ‘trials’ do they not understand?”
She said, “Does Roche expect applause for announcing that it will continue to keep clinical trial findings hidden? They’re on another planet. Thousands of people are calling for all clinical trials to be registered and the findings published. Patients, researchers, and practitioners are petitioning organisations and regulators for change all over the world. Just today the UK’s Health Research Authority signed up, joining a throng of research organisations, regulators, patient groups, and professional bodies.” (Más)
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