* Says will give third-party researchers access to trial
* Follows GSK decision to publish reports and data
* Drugmakers under pressure to increase transparency
ZURICH, Feb 26 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 organisation 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
anonymised 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.
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 U.S. Food and
Drug Administration and the European Medicines Agency.
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
Roche also said it would make arrangements to make public
three Roche-sponsored Tamiflu trials that are not currently
The company has been embroiled in a bitter row over the
trial data, and in an attempt to appease critics it said in
November that it would set up a multi-party advisory board to
review all the Tamiflu data.
It said that it has agreed to allow a board of experts from
academia and private institutions to decide what analyses are
useful in assessing Tamiflu's public health role and all
requested Tamiflu trial data will then be handed over.