The importance of transparency

Studying experimental medicines in people is a vital part of the development process for all new medicines and vaccines. At GSK, we recognise the importance of publicly disclosing this research and, in recent years, have made a number of commitments to share information from our clinical trials.

We believe all those involved in the conduct and publication of clinical research, be they companies like GSK, academic institutions or research organisations, have a role to play in ensuring that information from clinical trials is made publicly available.

Back in 2004, we introduced our publicly accessible Clinical Study Register online — where we post information about the clinical research we carry out on our existing medicines and also the ones that we are developing. We were the first pharmaceutical company to do this.

Our trial results are made public regardless of whether they reflect positively or negatively on our medicines. We believe this is fundamental to the advancement of medical science. It is also the best way to tell prescribers and patients about scientific findings relating to our medicines.

In addition to posting this information to the register, we seek publication of the results of all our clinical research in peer-reviewed scientific journals. Peer-reviewed means the research is assessed independently before publication. Journal editors make the ultimate decision whether or not to publish a submitted paper.

Building on our initial commitments to transparency, in February 2013 we agreed to publish the clinical study reports (CSRs) for all new studies on our medicines in line with the AllTrials campaign. CSRs are the formal study reports that we prepare to provide more detail on the design, methods and results of our clinical trials. They form the basis of the information we provide to regulators when submitting a medicine for approval for use in patients.

We publish CSRs for all new studies on our medicines — both those that are approved by regulators and ones that are terminated from development. These will be included alongside the other study information on our online register. In addition, we are also publishing historic CSRs for clinical outcomes trials for our approved medicines dating back to when GSK was formed in 2000. This is a significant volume of studies and we have a dedicated team working to retrieve and examine the historic CSRs and remove any confidential patient information.

There is a highly detailed level of data sitting behind the results of our clinical trials that scientific researchers may find useful. This is known as patient-level data. In May 2013, we launched a web-based system for researchers from the scientific community to request access to the anonymised patient-level data from our studies.

We were the first organisation to develop a system for sharing detailed clinical data in this way, to help increase understanding of our medicines by enabling researchers to examine the detailed data behind our trials more closely and do their own analyses. Appropriately qualified researchers can request trial data to support their own research and, hopefully, benefit medical science and patients. This system launched in January 2014 and is open to other companies. Already GSK and 11 other companies use the common website www.clinicalstudydatarequest.com.

GSK studies are listed on this system once a medicine has been approved by regulators or terminated from development and the study has been accepted for publication. Studies that were submitted but did not progress to publication are also included. We have already populated the system with global studies conducted since 2007, and over the next two years we are adding global studies going back to 2000. Today more than 1500 studies are loaded, and we have already provided more than 50 research teams with access to data.

One or two requests have been to reanalyse data from old trials — which we support when carried out with appropriate scientific rigour — but the majority have been from researchers armed with a fresh perspective, using new research methods or trying to identify factors that predict disease progression or outcome. This research is an opportunity to advance medical science and improve patient care.

Achieving this important goal has required our industry to dedicate resources to find sustainable solutions and address legitimate concerns, like how to protect patient privacy and encourage appropriate scientific use of data.

At GSK, we would like to see a broad, independent data-sharing portal to provide access to data from across all of industry and academia. This concept is being developed by groups such as the Harvard Multi-Regional Clinical Trials Center (MRCT), the Wellcome Trust and the Arnold Foundation in partnership with the Institute of Medicine. We're excited to be involved in these discussions.

Data transparency of research or commercial practices is not an easy principle to put into practice, but we are seeing positive results. GSK was also the first pharmaceutical company in Australia to publish aggregated payments to healthcare professionals, and in 2016 we will stop payments to healthcare professionals for them to talk about our prescription medicines on our behalf.

Opening access to our data has not been quick or easy — we've been on this for more than a decade and there is still more work to be done.

The 35th GSK Award for Research Excellence (ARE) will be announced on 18 November 2015. The award, with its accompanying grant of $80,000, has played a part in assisting some of Australia's most important leaders and innovators in the medical research sphere.