Sharing our research
We are committed to reporting the results of clinical research that evaluates our medicines and vaccines, irrespective of whether the outcomes are perceived to be positive or negative. In addition, we are being more open with our expertise, know-how and intellectual property around research into neglected tropical diseases.
Clinical Study Register
We are committed to public disclosure of all our clinical research, irrespective of whether the results are positive or negative for our medicines. We believe this is fundamental to the advancement of medical science. It is also the best way to tell HCPs and patients about scientific findings relating to our medicines.
Our Clinical Study Register website is a resource for researchers, medical professionals and the public to access data from GSK-sponsored clinical studies.
Building on the 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 are also publishing historic CSRs for clinical outcomes trials for our approved medicines dating back to when GSK was formed in 2000. This will happen over the next few years and we are posting the reports in a step-wise manner, starting with CSRs for our most commonly prescribed medicines.
When people volunteer for clinical trials they expect that the results from those studies will be used to help others. An online system enables researchers to request access to these anonymised patient level data that sit behind the results of clinical trials from a number of pharmaceutical companies, including GSK. It is hoped that sharing these data with researchers will help to further scientific understanding and improve patient care.
This system will allow researchers to examine the study details more closely, do their own analyses and learn more about medicines and how they can best be used. Consistent with good scientific practice, researchers will be required to submit a research plan and to commit to transparency in the publication of their work.
BE/COM/0009/15 Oct 2015