GSK Backs Campaign to Increase Clinical Trial Transparency
GlaxoSmithKline (GSK) has become the first big pharma company to support the AllTrials campaign, which intends to improve clinical trial transparency.
The campaign, which is supported by Dr Ben Goldacre, Bad Pharma’s author, and Dr Fiona Godlee, BMJ editor, is pushing for registration of clinical trials and the disclosure of results and reports to help increase scientific understanding.
The pharmaceutical industry has been reluctant to submit the data to the public, and the ABPI have stopped short of signing up fully to AllTrials. The announcement therefore appears as though GSK are breaking rank, but the ABPI commented that “the decision to sign up to the Alltrials campaign is one for individual companies to make. The ABPI has long been an advocate of greater transparency in clinical trial data balanced with the need to ensure that disclosure policies protect patients’ personal data, companies’ intellectual property rights and confidential commercial information.”
Current Clinical Trial Transparency
Presently, GlaxoSmithKline publicly reveal a substantial amount of information regarding their clinical trials, however they do not disclose all of the data for every trial.
The support comes regardless of the business being found to be withholding information regarding the safety of their diabetes drug, Avandia. The organisation is accused of trying to conceal negative data from Avandia’s RECORD study, which began in 2001 and was published in 2009.
GSK currently register and post summary information about all of their clinical trials when they begin and shares the results of their clinical trials – whether positive or negative – on a website available to all.
The firm have also previously agreed to seek publication of the results of all of their clinical trials that evaluate their drugs to peer-reviewed scientific journals.
In the future, GlaxoSmithKline have agreed to publish CSRs for all their drugs once they have been approved or discontinued from development and the results have been published. This is to allow the data to be initially reviewed by regulators and the scientific community. Patient data in the CSRs and their appendices will however be removed, in order to ensure patient confidentiality is upheld.
The organisation also plans to broadcast CSRs for clinical outcomes trials for all approved treatments dating back to the formation of GlaxoSmithKline in 2000.
As a result of the substantial volume of studies, the firm will allocate a dedicated team to carry out the work. Posting of the data will occur in a step-wise manner, with precedence given to CSRs for GSK’s most commonly prescribed treatments.
“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, the president of pharmaceuticals R&D at GlaxoSmithKline commented.
GSK also announced in October last year, that they would build a system where researchers will be able request access to comprehensive anonymous patient level data that sits behind the outcomes of clinical trials to aid additional scientific inquiry, and analyses to aid additional scientific knowledge.