We have a long-standing commitment to clinical data transparency. Here we give an insight into our initiatives to increase access to our clinical research.
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 have made a number of commitments to share information from our clinical trials.
Back in 2004 we introduced our publicly accessible?GSK Study Register?online – a place where anyone can access 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 over 6,000 summaries of our clinical studies.
Our study results are made public regardless of whether they reflect positively or negatively on our medicines. When a trial begins we post 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.
Our trial results are made public regardless of whether they reflect positively or negatively on our medicines.
In addition to posting this information to our register and other registers such as clinicaltrials.gov, we have also committed to seek publication of the results of all our clinical research on our medicines in peer-reviewed scientific journals. Authors are strongly encouraged to consider submitting to Open Access journals or select open access options where available in standard journals, to support GSK’s commitment to data transparency.?
Publishing our Clinical Study Reports
Building on these existing commitments to openness and transparency, in February 2013 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 have published historic CSRs for clinical outcomes trials for our approved medicines dating back to when GSK was formed in 2000.?There are more than 2000 CSRs available on our register.
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. 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. Following the launch of that system, we then worked with other companies and trial sponsors to re-configure it into a broader version, enabling researchers to request access to data from multiple study sponsors, not just GSK.?The system launched in January 2014?and is now used by 19 industry sponsors and academic funders.?
We believe that all those involved in the conduct and publication of clinical research...have a role to play in ensuring that information from clinical trials is made publicly available.
GSK studies are?listed on this system once a study has been published. Studies that did not progress to publication?are also included. We have populated the system with global studies conducted since the formation of GSK in 2000. Moving forward, all studies?that started?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. Today, more than 2,000 studies are available upon request.?
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 to our studies by providing a scientific research proposal with a commitment to publish their findings.?Their proposal is then reviewed by an independent review panel appointed and managed by the global charitable foundation, Wellcome Trust.
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.