GSK announces support for clinical trial transparency

Feb 5, 2013 (CIDRAP News) – GlaxoSmithKline (GSK) today announced that it has signed on in support of the AllTrials campaign, a push by scientists and medical groups to urge drug makers and other researchers to register clinical trials and fully disclose the results.

GSK said in a press release that it is committing to make its clinical study reports (CSRs) publicly available through its clinical trials register. CSRs are formal reports that describe details about study design, methods, and results, and are the basis of submissions to the US Food and Drug Administration (FDA) and other regulatory agencies.

The company said it already shares a significant amount of information about its clinical trials on a publicly available Web site and has vowed to publish the results of clinical trials in peer-reviewed scientific journals.

AllTrials is an initiative that was launched on Jan 9 led by five key groups, including the BMJ Group, a Web site called Bad Science, the Centre for Evidence Based Science, the James Lind Alliance, and Sense About Science. More than 50 science research groups, including the Cochrane Coalition and Wellcome Trust, have signed an AllTrials petition pressing for full registration of clinical trials and the reporting of results to help guide medical care and assist other researchers.

GSK's announcement comes just months after the British journal BMJ renewed its high-profile campaign to persuade the drug company Roche to release unpublished clinical trial data on the flu antiviral drug Tamiflu (oseltamivir). The journal also announced that in the future it would publish only drug trials from sponsors who agree to release all trial data when requested.

Roche has said nearly 80% of Tamiflu clinical data have been published or made available to scientists online and that most of the rest come from recently completed studies.

In its statement today GSK said from now on it will publish CSRs for all of its medicines once they have been approved or discontinued from development and the results have been published. "This is to allow for the data to be first reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will be removed to ensure patient confidentiality is maintained," the company said, adding that it will eventually publish CSRs for clinical trials for all approved medicines dating back to the formation of GSK in 2000.

Patrick Vallance, MD, PhD, the company's president of pharmaceuticals research and development, said in the statement, "We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment. Our commitment also acknowledges the very great contribution made by the individuals who participate in clinical research."

Ben Goldacre, MBBS, a physician and epidemiologist who has written columns and books about scientific inaccuracy and pharmaceutical marketing, helped form the AllTrials initiative and publicized the group's mission on his Bad Science Web site. In a Web post today on GSK's announcement he wrote, "I couldn't be any happier. This is huge, and internationally huge."

He said GSK's announcement addressed the practicalities and implications of posting the CSRs. "Because they have discussed these technical details—while I will always wait for the proof in the pudding—I do not believe this is mere lip service."

He explained that CSRs are important, because brief summaries of trials in scientific journals, for example, can be incomplete or misleading

See also:

Feb 5 GSK press release

Feb 5 Bad Science Web post

Nov 2, 2012, CIDRAP News story "BMJ renews pressure on Roche to release all Tamiflu trial data"

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