See-Through Science at GSK
Data transparency is vital for rebuilding patient trust in the pharma industry.
Murray Stewart |
GlaxoSmithKline made its initial commitment to clinical trial transparency 12 years ago in 2004, when we announced that we would publish protocols and summary results of our clinical-phase trials. We have been true to our word, with nearly 6000 clinical trials reported to date.
Setting up our register was a significant undertaking in terms of organization, staffing and the associated costs, but we quickly got into the swing of things – and the benefits are clear. Previously, our primary forum for sharing data was through peer reviewed journals. But, while a positive study usually generates interest from editors and reviewers, negative results tend to go to the back of the queue. Even when a manuscript is accepted, it often won’t be published for another six months. By publishing results – positive or negative – on our own register, we can ensure they are made public in a timely manner.
In 2013, we went a step further – joining the AllTrials initiative, and making clinical study reports (CSRs) publically available. CSRs are the formal reports we prepare on our clinical trials, which form the basis of regulatory submissions. Also in 2013, we created a secure system through which external researchers can request access to patient level data – the detailed, anonymized data that lies behind our clinical trials. Researchers can apply for access to datasets (1500 so far) via a web portal – all requests are reviewed by the independent, nonprofit Wellcome Trust and we expect the researchers to publish the results.
Over 100 applications have been accepted, with some interesting analyses published as a result. A few of these requests have been to re-analyse data from old trials – which we support when carried out with appropriate scientific rigour – but most have been from researchers coming from a different angle or new perspective, or using new research methods. As well as advancing medical science, which benefits patients in the long run, making data available to external researchers benefits GSK and our industry as a whole by building public trust. The key to data transparency is that the whole scientific community must be involved. No single organization can do it alone – we need all pharmaceutical companies and academics to engage. We joined the AllTrials campaign because they are committed to that goal, and we felt aligned with their principals and philosophies.
Since establishing our patient level data portal in 2013, we’ve been encouraging other companies to join us; so far, 13 companies have joined and I think we’ll see more as the benefits become even clearer. No doubt it’s a long journey and challenges remain. Patient confidentiality has to be addressed, and enabling data sharing involves resources – companies have to commit dedicated staff to the analysis of the data, as well as the right technology to make it work.
It is absolutely essential that all companies developing drugs – and even academic researchers involved in the development of medicines – should act in the interests of patients – and open access to data is certainly in patients’ best interests.
We know our system isn’t perfect and we’re always looking to refine this, based on user feedback. And we know we have work to do internally to ensure obstacles to timely publication of results are eliminated wherever possible. We’re also keen to explore how we might better communicate our findings to non-scientists.
For companies who remain resistant to data sharing, I would only add that it’s not as difficult as you might think. Putting up hurdles will not work forever – so embrace the benefit to your company and the industry as a whole. The pharma industry has been viewed with mistrust in the past; transparency is a vital step towards regaining the trust of patients and the public.
Murray Stewart is Chief Medical Officer, GlaxoSmithKline, Philadelphia, PA, USA.