Advances in genomics and techniques for understanding someone’s genetic information are allowing us to move away from the traditional trial and error approach to treating diseases. By better understanding conditions and the genetic factors that determine a treatment’s effectiveness we can find the most appropriate way to get the best and quickest outcomes for patients.
Understanding how to apply genetic information to clinical decision making requires complex analysis to process and interpret data on genetics, disease progression (including diagnostics), lifestyle, treatment and outcomes. Insights may then be used to deliver more personalised treatments whilst keeping patient data safe and non-identifiable by researchers.
For researchers dealing with enormous volumes of data, secure access is only one part of the challenge. That data needs to be arranged, manipulated and analysed, often in combination with other datasets, to be useful for research. Many research institutions and data providers have their own trusted research environments (TREs), which are secure spaces for researchers to access and analyse sensitive data.
In 2019 Eastern AHSN was part of a colllaborative team that successfully secured funding from Health Data Research UK (HDR UK) to deliver a proof of concept that the data of patients with rare diseases could be effectively de-identified and made available for analysis in a secure cloud research environment. This was successfully delivered as a pilot project (Sprint Exemplar: Cloud-based integration of patient data to aid rare disease research), focusing on the data of around 1,600 patients.
Following the success of the initial pilot, which saw the team named HDR UK Team of the Year, Eastern AHSN convened partners to successfully secure a further £5m from HDR UK to develop Gut Reaction – the Health Data Research Hub for Inflammatory Bowel Disease (IBD). The hub built upon the learning from the sprint pilot to integrate data from the NIHR IBD BioResource, a national platform which draws together the data of thousands of patients who have already provided consent for their health records to be retrieved and used for medical research, with ‘real-world’ data from participating NHS hospitals and the IBD Registry. This enables researchers to use the pooled data to support important research into IBD.
This involved not just building the technical architecture to create a secure research resource but to also ensure there are robust processes in place to manage how approved researchers access data whilst protecting the privacy of individuals.
Our role has focused on operational and programme management, coordinating activities across workstreams and project governance including reporting and assurance to our funders. Involving patients in decision-making about how their data are used for patient or societal benefit has been central to the work of Gut Reaction. This year, we have worked closely with our Patient Advisory Committee to design and implement a new data access process for inflammatory bowel disease data access applications. This approach will be reviewed after 12 months and, if successful, further refined and extended to all data access applications across the entire NIHR BioResource.
Rosanna, Crohn’s Disease patient commented;
“Patients with inflammatory bowel disease need to find the most effective treatment as quickly as possible to limit disease progression – but currently this process can take three or more years of trial and error. This initiative makes the tantalising prospect of personalised medicine real for patients, who for the first time will have the confidence that they have been prescribed the most effective treatment for them from the start.”
Researchers can use extracts from these linked datasets to support important research into inflammatory bowel disease. We have already had numerous requests from researchers to use the Gut Reaction data, many of which have passed the criteria and been approved to enable them to begin their studies.
Over the final 12 months of project funding, by drawing on the experience of the partners comprising Gut Reaction and building on our successes a sustainable model for data sharing for innovation in inflammatory bowel disease has been developed. This means the hub will be able to continue beyond the funded period under the umbrella of the NIHR BioResource, helping to drive discovery and innovation.
As a result of the proof of concept behind Gut Reaction, DARE UK and UK Research and Innovation (UKRI) two further Sprint Exemplar Projects which aimed to uncover and test early thinking in the development of a more joined-up and trustworthy national data research infrastructure.
Ensuring a patient-centred approach
Involving patients in decision-making about how their data are used for patient or societal benefit has been central to the work of Gut Reaction. The team worked with Crohn’s & Colitis UK and its Patient Advisory Committee to ensure that patient co-design and responsible use of data is at the heart of how we manage access requests to this growing dataset.
“The Gut Reaction Patient Advisory Committee has played a vital role in changing the culture of health data research by encouraging greater patient involvement in procedures in place to manage data access applications.” – Sarah Sleet, Chief Executive of Crohn’s & Colitis UK
This patient-centred approach was recognised at HDR UK’s annual awards in December 2022, where the project won the Public and Patient Involvement and Engagement Award.
If you want to learn more about our work in health data research and informatics contact [email protected]
Gut Reaction was established with funding from HDR UK and the Office of Life Sciences (OLS) Industrial Strategy Challenge Fund (ISCF) and is led by the NIHR BioResource. Partners include Eastern AHSN, AIMES, Cambridge University Health Partners, Cambridge University Hospitals NHS Foundation Trust, Crohn’s & Colitis UK, Leeds Teaching Hospitals NHS Trust, Manchester University NHS Foundation Trust, Microsoft, Newcastle upon Tyne Hospitals NHS Foundation Trust, Pennine Acute Hospitals NHS Trust, Privitar, Royal Devon and Exeter NHS Foundation Trust, Royal Liverpool and Broadgreen University Hospitals NHS Trust, Salford Royal NHS Foundation Trust, UK IBD Registry Ltd, University of Cambridge, University College London Hospitals NHS Foundation Trust and Western General Hospital, Edinburgh.