We make sure we carry out our research to high ethical and quality standards in all the countries in which we operate.
Investment in R&D is at the core of our business and we make sure we carry out our research to high ethical and quality standards in all the countries in which we operate. Whether it’s a patient’s safety during a clinical trial or the necessary use of an animal in our research, we always apply recognised standards and principles of good medical science, integrity and ethics. All our clinical trials follow the guidelines developed by the International Conference on Harmonisation (ICH), and the World Medical Association Declaration of Helsinki on the Ethical Principles for Medical Research Involving Human Subjects (2008).
Anyone who takes part in clinical trials must voluntarily confirm they are willing to participate, after being told about the study and its benefits and risks. We aim to address any concerns by being open about our research and regularly engaging with academic scientists, regulators, policymakers and other stakeholders.
Transparency of our research
The safety and effectiveness of new medicines must be demonstrated through clinical trials. Providing greater access to data from these trials – regardless of whether the results might be considered positive or negative – allows others to conduct further research. This also helps us ensure we maximise the contribution made by the thousands of volunteers and patients participating in our studies.
Since 2004, we have had an online clinical study register where we make available information on our trials, including summaries of results. We have led the industry in sharing information and data about trials to advance medical science and patient care and were the first company to make Clinical Study Reports (CSRs) publicly available. These formal reports are the basis of submissions to regulatory agencies and include detailed information on the design, methods and results of our trials. We post them on our clinical study register with patients’ personal information removed.
We were also the first pharmaceutical company to sign up to the AllTrials campaign for trials to be registered and results reported.
We also share the detailed patient-level data that sit behind clinical trial results to support further research that can advance science and improve patient care. This data is anonymised to protect patient confidentiality. To access it, researchers must submit research proposals to an independent review panel to ensure the data will be used for valid scientific enquiry.
GSK set up a system for researchers to request access to data (www.clinicalstudydatarequest.com) which now lists over 2,000 of our global clinical trials conducted since the formation of GSK and includes clinical trials from 19 other companies. Initially, proposals were reviewed by a panel of external independent experts appointed by GSK. Proposals are reviewed by a panel of external independent experts appointed by the Wellcome Trust.
We are working on alternatives to using animals in our research and ensuring that animals are used only where required. Read more on our Research pages.