In an article in the ‘Explore GSK’ section under the ‘Data transparency’ tab in depths of the serpentine labyrinth that is GSK’s corporate website, the company’s Chief Medical Officer James Shannon writes:
In addition to posting information to the register, we have also committed to seek publication of the results of all our clinical research on our medicines in peer-reviewed scientific journals.
Much as I am sure that all interested parties will welcome this, I suspect that they would also have appreciated some insight into whether ‘seeking publication’ means ‘continuing to seek publication of results of our clinical research until they are accepted, or else self-publishing them’. As Anne Marie Cunningham reminded me, observers would also like to know whether this year’s, last year’s, and indeed all other available archival clinical trial data from preceding decades will also be made available.
They may also wonder not unreasonably wonder why GSK doesn’t cut out the middleman by going down the green open access route and self-archiving everything themselves anyway, then perhaps linking to the data from an entry on the clinical trial on Wikipedia.
Would that be breaking anyone’s rules? If so, should an open discussion be had around the issue in order to ascertain whether any obstacles so identified could be overcome?
Discoverability (as well as access) remains a concern: GSK.com’s global traffic rank on Alexa was 45,147 at the time of writing, which isn’t too shoddy — until you think that Wikipedia’s is currently 6.
If a study is not published, because for example, an independent journal does not accept our proposed publication, we provide additional information on our online register to supplement the summary of results.
Again, why not just self-archive the full data set on a GSK repository?
Building on these existing commitments to openness and transparency…
Might observers not deem this a touch self-congratulatory in view of the fact that a mechanism already exists whereby GSK could be sharing the totality of the clinical trial data it sees fit to facilitate public access to that has not yet been adopted? Putting that aside:
…in October 2012 we announced plans to create a system enabling researchers to access the anonymised patient-level data that sits behind the results from our clinical trials of our approved medicines and discontinued investigational medicines.
To be sure this information is not misused, which could be detrimental to medical science and patient care…
Some examples of the sort of detriments being referred to here may have assuaged the uneasy sensation that one’s attention is being diverted at this point (‘Over there!’), but pressing on:
…research requests will need to be submitted with proposals, which will be reviewed for scientific merit by an independent panel of experts. If approved, access to the data will be granted via a secure web site. This will enable researchers to conduct further research.
This is clearly an entirely new definition of ‘data transparency’ of which up until today I have remained unaware that appears to exclude many of the stakeholders who will be most interested. At least the data are not going to be on display in the bottom of a locked filing cabinet stuck in a disused lavatory with a sign on the door saying ‘Beware of The Leopard’.
This initiative is a step towards the ultimate aim of the clinical research community developing a broader system where researchers will be able to access data from clinical trials conducted by different sponsors. We hope the experience gained through our initiative will be of value in developing this wider approach.
We want to be transparent, while recognising that as a commercial business there are some things that we can’t share. However, we are committed to enabling the scientific community to learn from what we know, providing information to support ongoing research and giving patients and health professionals more confidence in the data that support our medicines.
All stakeholders in health want GSK to be transparent too, and whilst I commend this first step towards data transparency and hope that their example is followed by many other pharma companies, it remains to be seen whether the stamina required to embark upon a journey this challenging will be exhausted by this initial burst of activity. One hopes not, on the basis that industry members’ evolution as social businesses committed to adopting ethical positions and aligning revenue generation with a visible commitment to doing social good hinge upon enterprises such as this.
More questions are left hanging than are answered, and for a position piece detailing GSK’s stance with regard to transparency, it’s a shame that a more robust, detailed, and clearly delineated explanation as to where, how and with whom the company will share its clinical trial data could not have been offered here.