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Data transparency

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

In 2013 we became the first company to proactively post full Clinical Study Reports onto public registers. We retrospectively posted full CSRs for: clinical trials (phase I-IV) for approved and terminated medicines dating back to the formation of GSK in 2000: and all non-interventional studies conducted since 2009 that have evaluated the safety and efficacy of our medicines.

In 2022, with researchers and the public increasingly able to access full clinical study reports via regulatory processes (e.g. in the EU and Canada) we changed our voluntary position to post the CSR synopsis on our trial register.

We post Clinical Study Report synopses on internet registers after product approval for the indication studied, product terminated or after the study has been published (whichever is latest).  It is also possible for researchers to request access to full Clinical Study Reports.

There are more than 2000 CSRs / CSR Synopses available on our register.

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. 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 list Phase I-IV clinical trials on the system within 6 months of the product being approved.

Today, more than 2,000 studies are available upon request. 

 

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.

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.