* Drugmakers under fire for keeping medicine data secret
* New move builds on previous GSK pledge to be more open
* GSK will now publish detailed clinical study reports
* Industry critic Ben Goldacre says GSK move “excellent”
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 trials.
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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