GSK to make all clinical trials data public
Will support the AllTrials campaign
UK pharmaceuticals manufacturer GlaxoSmithKline (GSK) is to make more of its research data public by publishing detailed clinical study reports (CSRs) as well as the results of all drug trials.
GSK says it will support the AllTrials campaign, which is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports (CSRs) to help drive further openness in the industry.
The AllTrials campaign – driven by organisations including Sense About Science, Bad Science, BMJ, James Lind Alliance and Centre for Evidence-based Medicine – is calling for the publication of the results from all clinical trials on treatments currently in the market.
Ben Goldacre, author of Bad Science, said GSK’s support for the initiative was ‘excellent and amazing’.
GSK, which agreed a US$3bn US settlement last July over misleading information about its diabetes drug Avandia, already said last October that it would develop a system where researchers would be able request access to detailed anonymised patient level data to help further scientific knowledge.
The company said it already publicly discloses a ‘significant amount’ of information about its clinical trials, registering and posting summary information about each trial it starts and sharing the results on its GSK Clinical Study Register. This website includes almost 5,000 clinical trial result summaries.
We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment
However, from now, GSK said it would publish CSRs, which are the formal study reports that provide more details on the design, methods and results of clinical trials and form the basis of submissions to the US FDA, European Medicines Agency and other regulatory agencies.
Patient information will be removed to ensure confidentiality.
Patrick Vallance, GSK’s President of Pharmaceuticals R&D, said: ‘We are committed to being transparent with our clinical trial data to help advance scientific understanding and inform medical judgment.’
GSK also intends to publish CSRs for all approved medicines dating back to the formation of the company in 2000. It said this would take time, as it would require the retrieval and examination of each historic CSR to remove confidential patient information.
‘Given the significant volume of studies involved, the company will put in place a dedicated team to conduct this work which it expects to complete over a number of years,’ the company said.
In a statement about GSK’s decision to publish its data, the ABPI said it 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.
The AllTrials campaign is one of a number of initiatives addressing the transparency issue
‘We have been actively involved in progressing this issue with all stakeholders. The AllTrials campaign is one of a number of initiatives addressing the transparency issue. Others include the EMA work streams, the Science and Technology Committee Inquiry and changes to the ABPI Code of Practice in 2012.
‘The decision to sign up to the AllTrials campaign is one for individual companies to make.’
GSK’s decision could stimulate other pharmaceutical manufacturers to follow suit, especially as negotiations are about to begin on a newly proposed clinical trial regulation in the EU.
Rapporteur Glenis Wilmott said earlier this week that she wanted to see comprehensive results from clinical trials published on a public database and financial penalties imposed on manufacturers that do not upload their results on time.
‘For too long unflattering studies have gone undisclosed,’ she said. ‘It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective or even dangerous.’
