Bioanalytical
GSK supports AllTrials campaign for clinical data transparency
Feb 07 2013
GlaxoSmithKline (GSK) has shown its commitment towards clinical trial transparency by announcing its backing of the AllTrials campaign.
The campaign is calling for registration of clinical trials and the disclosure of clinical trial results and study reports, which will help to further scientific understanding of treatments.
At the moment, GSK already reveals a substantial amount of information about its clinical trials, with the company registering and posting summary information of every trial it begins, before sharing the results of its clinical trials regardless of whether they are positive or negative.
Its website currently includes nearly 5,000 clincial trial result summaries, along with an average of nearly 11,000 visitors every month.
GSK has also committed to seek publication of the results of all of its clinical trials to review its medicines.
It is hoping to make clinical study reports publicly available through its clinical trials register. These are formal study reports that provide information on the design, methods and results of clinical trials, forming the basis of submissions to the US Food and Drug Administration and other regulatory agencies.
GSK has vowed to publish CSRs for all of its medicines after they have been approved or discontinued from development, enabling regulators and the scientific community to conduct reviews.
When there are practical challenges, the company intends to publish CSRs for clinical outcomes trials for all approved medicines, going all the way back to the formation of GSK.
Patrick Vallance, president, pharmaceuticals research and development, GSK, said: "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.
"All those involved in the conduct and publication of clinical research, whether healthcare companies like GSK, academia or research organisations, have a role to play in ensuring that the data they generate are made publicly available to help bring patient benefit."
Posted by Ben Evans
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