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.
The GSK Study Register
The GSK Study Register is an online portal where anyone can access information about the clinical research we carry out on our existing vaccines and medicines. We were the first pharmaceutical company to make this information available online.
As part of our commitment to transparency, we disclose all human subject research of GSK products. This includes phase I-IV clinical trials and observational studies of both investigational and marketed products. We register the protocol summaries before we start the trial and we post the results summaries within a year of study completion. Our study results are made public regardless of whether they reflect positively or negatively on our vaccines and medicines. The GSK Study Register now includes over 6,000 summaries of our clinical studies.
Since the beginning of 2020 we have initiated development of plain language summaries of our clinical trial results. These are summaries of clinical trial results written in simple language understandable to a layperson. We develop these summaries for our phase II-IV trials and share them with the study investigator for distribution to trial participants, in addition to posting them on the GSK register and on Trial results summaries.
In addition to our study register and others such as ClinicalTrials.gov , we also seek to publish our clinical research results in peer-reviewed scientific journals. To support our commitment to data transparency, authors are strongly encouraged to submit to open access journals or select open access options where available in standard journals
Publishing our clinical study reports
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 vaccine or medicine is submitted to them for approval.
Since then, we have published over 2700 CSRs for our approved medicines and vaccines, dating back to the formation of GSK in 2000.
More recently, the European (2015) and Canadian medicine regulators (2019) implemented policies to disclose CSRs and matched the commitment GSK had made voluntarily since 2013. With Clinical Study Reports now available via many regulated processes, in 2022 we moved to post the CSR synopsis on our trial register and focus our efforts on improving transparency in other areas.
We 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. Soon after we collaborated with other companies and trial sponsors to broaden that system and enable researchers to request access to data from multiple study sponsors. The updated system, launched in January 2014 and is now used by 13 industry sponsors and academic funders.
Independent review panel
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 who are appointed and managed by the global charitable foundation, Wellcome Trust