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* 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 drugmakerGlaxoSmithKline is extending a promise to make more ofits pharmaceutical research data public by publishing detailedclinical study reports as well as the results of all drugtrials.
The decision marks a new level of openness in the drugsindustry that other companies may be under pressure to follow.Drugmakers have long been criticised for keeping importantinformation 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 urgingclinical study report (CSR) disclosure, said GSK's support forthe initiative was "excellent and amazing".
GSK, which agreed a $3-billion U.S. settlement last yearover misleading information about some of its drugs, alreadysaid in October it would make anonymised patient-level data fromclinical trials available to other researchers.
"Expanding on this, GSK is committing to make CSRs publiclyavailable through its clinical trials register," the firm saidin a statement on Tuesday.
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 European Medicines Agency.
Campaigners argue that CSRs are essential to assess the realvalue of medicines because brief summaries about trials, such asthose published in academic journals, can be incomplete.
GSK said that from now on, it would publish CSRs for all ofits medicines once they have been approved or discontinued fromdevelopment. This would allow for the data to be first reviewedby regulators and the scientific community, it said. Patientinformation will be removed to ensure confidentiality.
Patrick Vallance, GSK's president of pharmaceuticalsresearch and development, said the promise was aimed at helping"advance scientific understanding and inform medical judgment".
"Our commitment also acknowledges the very greatcontribution made by the individuals who participate in clinicalresearch," he added.
Demands for greater transparency by the drug industry havecome to a head in Britain with the AllTrials campaign, whosesupporters include the group Sense About Science, the BritishMedical Journal and the Centre for Evidence-based Medicine.
In an apparent effort to put its past record straight, GSKalso said it intends to publish CSRs for clinical outcomestrials for all approved medicines dating back to the formationof the company in 2000.
It said this would take time and resources as it wouldrequire retrieval and examination of each historic CSR to removeconfidential patient information.
"Given the significant volume of studies involved, thecompany will put in place a dedicated team to conduct this workwhich it expects to complete over a number of years," it said.
