We launched our system in May of 2013 to provide researchers with access to patient level data from our studies with the fundamental belief that greater access to these data would facilitate further research to advance medical science and lead to improvements in patient care. I am sorry that Professor Jureidini and his team have had difficulty working within the system. We worked hard to develop an approach that would provide access for legitimate research while ensuring that the patient confidentiality of those who have taken part in our clinical trials isn’t compromised.
The system has been live for over 12 months and, although originally developed to provide access to GSK’s patient-level data, now has support from seven other industry study sponsors. Proposals from researchers are independently reviewed for scientific merit by a panel at arm’s length from the study sponsor and access to anonymised data and a variety of common analytical tools is provided in a secure internet site in which researchers conduct their analyses – the data itself cannot be downloaded from this site. This is different to our approach to clinical study reports – these documents, without individual patient data, are being posted publicly on our clinical study register, where they can be freely downloaded.
We are pleased that there is such interest from the research community in conducting research with GSK’s anonymised patient-level data; over 50 research proposals have been received, most of these have been approved and many research teams now have access to data in the system. When researchers are granted access, recognising the size and complexity of the data, we do proactively offer support to help them effectively navigate the datasets. We also always knew that as researchers started using the system this would generate questions about its capabilities and suitability for supporting researchers’ work. Hearing from real-world users will help with future improvements to the system and guide how we can best support research teams with their analyses. I hope we can continue to receive feedback, good or bad, from users about their own experiences.
Chief Medical Officer
Competing interests: No competing interests