GlaxoSmithKline has become the first big pharma firm to support the AllTrials campaign that aims to increase clinical trial transparency.
The campaign, which is being supported by Bad Pharma author Dr Ben Goldacre and BMJ editor Dr Fiona Godlee, is calling for registration of clinical trials and the disclosure of clinical trial results and clinical study reports to help drive further scientific understanding.
Goldacre immediately took to Twitter to express his delight that GSK has signed up to the campaign, saying the firm’s backing was: “Amazing.Fantastic.Historic[…]This is the beginning of the end for a dark era in medical history.”
The industry has been resistant to publishing all of its data for the public to see, and the UK lobby group the ABPI has stopped short of signing up fully to AllTrials. This seemingly looks as if GSK is breaking rank, but the ABPI said: “The decision tosign up to the Alltrials campaign is one for individual companies tomake. The ABPI has long been an advocate of greater transparencyin clinical trial data balanced with the need to ensure that disclosurepolicies protect patients’ personal data, companies’ intellectualproperty rights and confidential commercial information.”
Increasing transparency
GSK already publicly discloses a significant amount of information about its clinical trials – but not all of them – and is the first big pharma firm to get behind the AllTrials campaign.
Its backing comes despite the firm being found withholding information about the safety of its diabetes drug Avandia, drawing criticism from both the BBC Panorama programme and the BMJ. The firm is accused of trying to bury negative data from Avandia’s RECORD study, which began in 2001 and was published in 2009.
The firm currently registers and posts summary information about each trial it begins and shares the results of all its clinical trials – whether positive or negative – on a website accessible to all.
This website includes almost 5,000 clinical trial result summaries and receives an average of almost 11,000 visitors each month. The company has also previously committed to seek publication of the results of all of its clinical trials that evaluate its medicines to peer-reviewed scientific journals.
Expanding on this, GSK is committing to make CSRs publicly available through its clinical trials register.
From now on, GSK says 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 however be removed says GSK, in order to ensure patient confidentiality is maintained.
Dedicated team
In addition, the company also intends to publish CSRs for clinical outcomes trials for all approved medicines dating back to the formation of GSK. This will require 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. Posting will take place in a step-wise manner, with priority given to CSRs for its most commonly prescribed medicines.
Patrick Vallance, president of pharmaceuticals R&D at GlaxoSmithKline, 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.”
Separately, in October 2012, and going further than the call made by the AllTrials campaign, GSK announced it would develop a system where researchers will be able request access to detailed anonymised patient level data that sit behind the results of clinical trials to enable additional scientific inquiry and analyses to help further scientific knowledge.
