By Kate Kelland and Ben Hirschler
LONDON, Feb 5 (Reuters) - Britain's largest drugmaker
GlaxoSmithKline is extending a promise to make more of
its pharmaceutical research data public by publishing detailed
clinical study reports as well as the results of all drug
The decision marks a new level of openness in the drugs
industry that other companies may be under pressure to follow.
Drugmakers have long been criticised for keeping important
information about their medicines under wraps.
Ben Goldacre, a British doctor and author of "Bad Science"
and "Bad Pharma", who has led a campaign called AllTrials urging
clinical study report (CSR) disclosure, said GSK's support for
the initiative was "excellent and amazing".
GSK, which agreed a $3-billion U.S. settlement last year
over misleading information about some of its drugs, already
said in October it would make anonymised patient-level data from
clinical trials available to other researchers.
"Expanding on this, GSK is committing to make CSRs publicly
available through its clinical trials register," the firm said
in a statement on Tuesday.
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 European Medicines Agency.
Campaigners argue that CSRs are essential to assess the real
value of medicines because brief summaries about trials, such as
those published in academic journals, can be incomplete.
GSK said that from now on, it would publish CSRs for all of
its medicines once they have been approved or discontinued from
development. This would allow for the data to be first reviewed
by regulators and the scientific community, it said. Patient
information will be removed to ensure confidentiality.
Patrick Vallance, GSK's president of pharmaceuticals
research and development, said the promise was aimed at helping
"advance scientific understanding and inform medical judgment".
"Our commitment also acknowledges the very great
contribution made by the individuals who participate in clinical
research," he added.
Demands for greater transparency by the drug industry have
come to a head in Britain with the AllTrials campaign, whose
supporters include the group Sense About Science, the British
Medical Journal and the Centre for Evidence-based Medicine.
In an apparent effort to put its past record straight, GSK
also said it intends to publish CSRs for clinical outcomes
trials for all approved medicines dating back to the formation
of the company in 2000.
It said this would take time and resources as it would
require retrieval and examination of each historic CSR to remove
confidential patient information.
"Given the significant volume of studies involved, the
company will put in place a dedicated team to conduct this work
which it expects to complete over a number of years," it said.
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