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Data transparency

Our latest initiative to increase access to our clinical research is the focus of a special report in the August 1 2013 issue of the New England Journal of Medicine. James Shannon, our chief medical officer, gives an insight here into our commitment to clinical data 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.

Back in 2004 we introduced our publicly accessible Clinical Study Register online – a place where we could 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.

Today this register includes almost 5,000 summaries of our clinical studies and receives an average of almost 11,000 visitors each month.

Our trial results are made public regardless of whether they reflect positively or negatively on our medicines. When a trial begins we post onto our study register a protocol summary, which includes the study’s objectives and design. Once the trial has completed, we provide a summary of the results. This is the case for all clinical research about our medicines.

In addition to posting this 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. If a study is not published because, for example, an independent journal does not accept our proposed publication, we provide a conclusion for the study on our online register to supplement the summary of results.

AllTrials and publishing our CSRs

Building on these existing commitments to openness and transparency, in February this year we announced our support for the AllTrials campaign, which calls for the registration of clinical trials and the disclosure of trial results and clinical study reports (CSRs). 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 a medicine is submitted to them for approval for use in patients.

We have committed to publish the CSRs for all new studies on our medicines – both medicines that are approved by regulators and ones that are terminated from development. These will now be included alongside the other study information on our online register. In addition, we will also be 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 so we are putting in place a dedicated team for this programme of work, to retrieve and examine the historic CSRs and remove any confidential patient information. This will happen over the next few years and we will post the reports in a step-wise manner, starting with CSRs for our most commonly prescribed medicines.

Patient-level data

We believe that 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. We also recognise that 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. At GSK we have developed a web-based system so that researchers from the scientific community can request access to the anonymised patient-level data from our studies.

Studies will be 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 do not progress to publication will also be included. We have already populated the system with global studies conducted since 2007, and over the next two years we will be adding global studies going back to the formation of GSK in 2000. Moving forward, all studies starting in 2013 and onwards will be included. This is a growing database and the number of studies available to researchers will obviously increase over time.  

Independent review panel

We want to ensure this detailed information is not misused, which could be detrimental to medical science and patient care. Therefore, consistent with expectations of good scientific practice, researchers can request access by providing a scientific protocol with a commitment to publish their findings.  Their protocol will then be reviewed by an independent review panel. A team of external independent experts - appointed by GSK and which has been working to develop the system - will be the initial review panel.

We are the first organisation to develop a system for sharing detailed clinical data in this way, and we hope it will help to increase understanding of our medicines by enabling researchers to examine the detailed data behind our trials more closely and do their own analyses. However, our ultimate aim is to see a broader system developed, allowing researchers to access data from trials conducted by multiple organisations. This system would be run by an independent third party who would be responsible for appointing and overseeing a review panel to assess research proposals. We are keen for this to progress and are already in discussions with interested parties to encourage the development of such a system. 

Our commitment to transparency of clinical trial data reflects our wish to help advance scientific understanding and enable the scientific community to learn from the research we have undertaken. It also allows us to acknowledge the great contribution made by the people who take part in our clinical research. These individuals give their time voluntarily and they do this with the hope not just that they might benefit from an investigative treatment themselves, but that they might ultimately be able to help a wider population through their contribution. When people volunteer for clinical trials they expect that the results from those trials will be used to help others. We have a responsibility to ensure that happens.