GlaxoSmithKline is to establish a new online system allowing researchers access to patient level data from the firm’s clinical trials.
This comes after the UK-based firm signed the AllTrials register in February, signalling its commitment to open up access to clinical trial data, and promising to make clinical study reports available.
But this new system goes beyond its AllTrials commitment, with the new online system, available at: https://clinicalstudydata.gsk.com/, enabling researchers the ability to request access to anonymised patient level data that sit behind the results of clinical trials.
It is hoped that sharing these data with researchers will help to further scientific research, increase understanding of new and current medicines and ultimately improve patient care, according to GSK.
Researchers can request access by providing a scientific protocol with a commitment to publish their findings. External independent experts appointed by GSK to advise on the development of the system will be the initial review panel, responsible for assessing research proposals made through the system.
This team includes Dr Brian Strom, George S Pepper Professor of Public Health and Preventive Medicine in the USA, who will be the panel’s chair, and John Hughes, patient and public involvement member of the UK Clinical Research Collaboration Board. But the pharma firm's independent experts selected to run the programme include at least two people with close ties to GSK, bringing the true extent of its independence into question.Access to the data from GSK’s studies will be provided on a password protected website to help protect research participants’ privacy and ensure the data are used for the approved scientific purpose.
The system would be run by an independent third party who would be responsible for appointing and overseeing a review panel to assess research proposals. GSK is already in discussions with interested parties to encourage the development of such a system.
Patrick Vallance, GSK’s president of pharmaceuticals R&D, said: “When people volunteer for clinical trials they expect that the results will be used to help others. We are the first organisation to develop a system for sharing detailed clinical data in this way. Now we want to see this initiative transition to a broader independent model that brings together data from multiple organisations. We are keen for this to progress and hope such a system can be put in place by a third party in the public or charitable sector as soon as possible.”
The studies will be listed on GSK’s system once a medicine has been approved by regulators or terminated from development and the study has been accepted for publication. Studies that do not progress to publication will also be included.
The system already includes global studies conducted since 2007. Over the next two years global studies going back to the formation of GSK in December 2000 will be added and in addition, all studies (including local studies) starting in or after 2013 will be included.
Importantly, studies that do not progress to publication will also be included in GSK’s promulgation – something very rarely undertaken by pharma or academia.
Greater transparency – the debate continues
GSK’s signing of AllTrials went against all other pharma firms and the UK lobby group the ABPI, none of which plan to sign the register, with the ABPI’s chief Stephen Whitehead calling it a “PR initiative”.
‘All Trials Registered, All Results Reported’ is an initiative of Sense about Science, Bad Science, BMJ, James Lind Initiative, the Centre for Evidence-based Medicine and others from research, patient groups and medicine.
AllTrials.net’s petition to has attracted more than 40,000 signatures and support from over 180 companies and organisations including GSK, as well as the UK’s drug pricing watchdog NICE. Its aim is to make sure that “all trials past and present” are registered and “the full methods and the results” reported.
Dr Ben Goldacre, Bad Pharma author and a key figure in the fight for great trial transparency, told PharmaTimes UK News: “GSK have made some great promises, and I hope they will deliver. Perhaps most significant is the discussion of collaboration with other companies, to develop a shared platform for access to trial data. These are systemic issues, and first movers will have a huge advantage.
“There is an outdated view in some corners of industry that transparency is somehow optional, and that this issue can be wished away. Those backward-looking companies, organisations, and individuals are taking a huge reputational hit, for little or no gain. It’s time for the ABPI, the [the US lobby group] PhRMA, and other organisations to accept that the world has changed around them, show clear leadership, and move towards greater transparency.
“Doctors, researchers, and patients need access to all the results, for all trials, of all uses, of all currently prescribed treatments, to make safe and informed decisions about which is best. The only discussion to be had on individual patient data is best practice for greater transparency. As the EMA have said: we need to discuss how, not whether, this will happen.”