Roche promises greater access to trial data

Campaigners have been urging drug companies to make research data available. Keystone

Swiss drug maker Roche has announced that it will make more of its clinical trial data available to researchers. This follows a similar move by British rival GlaxoSmithKline (GSK) this month.

Roche said on Tuesday that it would work with an independent body of experts to “evaluate and approve” requests to access anonymised patient data and would support the release of full clinical study reports (CSRs) for all its licensed medicines 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,” declared Daniel O’Day, chief operating officer of Roche Pharma.

O’Day said that the new process for accessing trial data would ensure patient confidentiality while avoiding the risk of publishing misleading results.

CSRs are formal study reports that provide more detail on the design, methods and results of clinical trials and form the basis of submissions to regulators such as the US Food and Drug Administration and the European Medicines Agency.

However, the announcement does not go far enough for some campaigners urging greater transparency in the industry.

Tracey Brown, director of the organisation Sense about Science, which helped start the AllTrials campaign to get all clinical research published, told the BBC: “Does Roche expect applause for announcing that it will continue to keep clinical trial findings hidden? They’re on another planet. Roche’s response is pathetic. Which bit of All and Trials do they not understand?”

Roche has been under pressure from critics, including the non-profit group The Cochrane Collaboration, to hand over data on its anti-viral flu drug Tamiflu amid claims from researchers that there is little evidence that it works.

The Swiss drug maker says it has set up a four-man panel from academia and private institutions headed by flu expert Albert Osterhaus to look at data on Tamiflu which the company says will “identify unanswered questions”.

Roche also said it would make arrangements to make public three Roche-sponsored Tamiflu trials that are not currently available.

Roche’s announcement follows a decision this month by GSK to commit to publishing the results of all its drug trials and to support the AllTrials campaign.

Last year Europe’s medicines regulator agreed to open its data vaults to

systematic scrutiny, allowing independent researchers to trawl through millions of pages of clinical trial information.