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Switzerland's Roche pledges to open up access to drug data

Tue, 26th Feb 2013 17:44

* Says will give third-party researchers access to trialdata

* Follows GSK decision to publish reports and data

* Drugmakers under pressure to increase transparency

ZURICH, Feb 26 (Reuters) - Swiss drugmaker Roche Holding has agreed to expand access to its clinical trial dataas the pharmaceutical industry faces calls for greatertransparency on scientific data.

The company's move follows a decision this month by Britishrival GlaxoSmithKline to publish detailed clinical studyreports as well as the results of all drug trials.

Roche has also come under pressure from critics, includingnon-profit organisation The Cochrane Collaboration, to hand overdata on its blockbuster flu drug Tamiflu amid claims fromresearchers that there is little evidence it works.

The drugmaker said on Tuesday that it would work with anindependent body to evaluate and approve requests to accessanonymised patient data and would support the release of fullclinical study reports (CSR) via regulatory authorities.

"We understand and support calls for our industry to be moretransparent about clinical trial data with the aim of meetingthe best interests of patients and medicine," Daniel O'Day, headof Roche's pharmaceuticals unit, said.

O'Day said that the new process for accessing trial datawould ensure patient confidentiality while avoiding the risk ofpublishing misleading results.

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 U.S. Food andDrug Administration and the European Medicines Agency.

Last year Europe's medicines regulator agreed to open itsdata vaults to systematic scrutiny, allowing independentresearchers to trawl through millions of pages of clinical trialinformation.

Roche also said it would make arrangements to make publicthree Roche-sponsored Tamiflu trials that are not currentlyavailable.

The company has been embroiled in a bitter row over thetrial data, and in an attempt to appease critics it said inNovember that it would set up a multi-party advisory board toreview all the Tamiflu data.

It said that it has agreed to allow a board of experts fromacademia and private institutions to decide what analyses areuseful in assessing Tamiflu's public health role and allrequested Tamiflu trial data will then be handed over.

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