GSK promises to publish clinical trial data
Hannah Blake
pharmaphorum
Britain’s largest drugmaker GSK has announced its support for the AllTrials campaign, in a move to further demonstrate its commitment to clinical trial transparency.
The AllTrials campaign was initiated by Ben Goldacre, the charity Sense About Science, the BMJ, the James Lind Alliance and the Centre for Evidence-based Medicine. The aim is to help drive further scientific understanding by calling for registration of clinical trials and the full disclosure of clinical trial results. To date, over 10,000 individuals have signed the petition, according to Trish Groves, Deputy Editor of the BMJ.
GSK already publicly discloses a significant amount of information about its clinical trials, but has promised to expand on this by committing to make clinical study reports (CSR) publicly available through its clinical trials register. 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 regulatory bodies such as the US FDA and the EMA.
“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.”
Patrick Vallance, President, Pharmaceuticals R&,D, GlaxoSmithKline.
From now, GSK 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.
Related news:
GSK promises to publish detailed drug trial data (Reuters)
GlaxoSmithKline to publish clinical trial data (The Guardian)
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