Following Gut Reaction’s successful virtual event for small and medium-sized enterprises (SMEs), Dr Louise Jopling – our Industry Collaboration and Sustainability Co-Executive Lead – reviews how partnerships with SMEs can lead to much-needed therapeutic breakthroughs for the inflammatory bowel disease (IBD) community and the ways in which Gut Reaction can support this progress
The role of health data research in IBD
As health data science and genomics continue to advance, new opportunities for developing more effective, tailored treatments for IBD have arisen. The need for, and appeal of, such innovation is clear; despite the ongoing efforts of healthcare professionals, management of patients living with IBD remains complex and challenging. In many cases delays in achieving disease control result in unacceptable impacts on quality of life, patient outcomes and use of limited NHS resources.
Securely-accessed, de-identified health data is a key resource for facilitating rapid research in this field, where a clear patient and wider-public health benefit is defined, however access to such rich data sources for IBD has previously been fragmented and limited the overall impact. In order to address this need, Gut Reaction – the Health Data Research Hub for IBD – was funded in 2019 by UK Research and Innovation’s Industrial Strategy Challenge Fund, creating an infrastructure for safe and responsible access to health data for research and innovation. This initiative is delivered by Health Data Research UK (HDR UK).
Gut Reaction is a unique health data resource for IBD, providing bespoke access to curated real-world data, specific to the research question posed. By linking lifestyle, research and genomic data from more than 34,600 consented IBD patients in the NIHR BioResource with real-world data from participating NHS Hospitals, the UK IBD Registry and other national datasets, Gut Reaction allows research that would not otherwise be possible. Researchers can apply to access wide-ranging datasets including demographics, health and lifestyle information, genetics, prescribing and diagnostics.
Tailoring our service offering to meet the needs of SMEs
Gut Reaction not only unites rich sources of patient data but also bring together a wealth of expertise across clinical care, data analytics, privacy, patient and public involvement and engagement (PPIE), project management and commercialisation. Through this experience, and alongside our close working relationships with pharmaceutical companies, we have developed a model which evolves to meet the needs of SMEs in a competitive landscape.
We recognise that SMEs face a particular challenge in IBD; although health data provides a potentially faster route to innovation in IBD compared with conventional preclinical/clinical studies, accessing and linking rich datasets in a timely and cost-effective manner is challenging. Through our work with the IBD community, and organisations undertaking research in IBD, Gut Reaction is working to find a mutually acceptable balance between the need to ensure data privacy and safety for the IBD community and the specific requirements of all industry partners in this space.
Gut Reaction are able to offer a range of services to maximise the utility of our data resource for SMEs, and ensure that bespoke support is available during our data access processes (Figure 1). In particular, we encourage potential data users to determine the feasibility of their research through engaging with our Data Management team, prior to a data access application and, when required, specific support during our application processes.
Figure 1: Gut Reaction offer a range of bespoke services to meet the needs of SMEs
Upon acceptance of a data access application, our Commercialisation Team will discuss the nature of the research to be undertaken and the degree of input required from our team. Dependent upon the size and complexity of the dataset, cloud-computing costs, any specific configuration requests and the long-term scope of the project, individual pricing structures can then be developed. Reflecting our long-term commitment to promoting innovation in this area, any revenues generated by the Hub will be reinvested to support Hub services, IBD research, and the participating not-for-profit organisations who have contributed to the Gut Reaction datasets. To ensure that the research organisation benefits equally from their investment, any Intellectual Property (IP) associated with data insights will be owned by the organisation that develops it.
Our Data Management Team are also available to arrange the accommodation of a range of data analysis tools within our trustworthy research environments (TREs). Additional requests such as brokering for specialist services including recall of participants, undertaking analysis on behalf of the applicant and use of AI or machine learning algorithms for imaging analysis or unstructured text analysis using natural language processing (NLP) may also be accommodated. The NIHR BioResource – one of the partners in Gut Reaction – is able to recall participants to ethically approved studies, and has some samples available. The NIHR BioResource encourages the use of Gut Reaction data as a feasibility step on the way to requesting access to samples or participants.
Future developments at Gut Reaction
Drawing on feedback from commercial organisations and insights from our partner organisations, we continue to invest in additional resources to improve accessibility for SMEs. We are currently developing a cohort discovery tool able to offer cohort construction and query prior to applying for data access. This tool, which uses i2b2/tranSMART, will allow potential researchers to rapidly determine how many records might satisfy a particular set of conditions prior to application, without accessing the underlying record level data. Work is also underway to increase the frequency of data access reviews, ensuring that prompt responses to data requests facilitate research being carried out within the required timelines. We also have a steady stream of new datasets becoming available, with data from the IBD Registry’s Covid-19 Risk Tool now available.
Gut Reaction is an evolving collaboration between patients, healthcare providers and research organisations united by a common aim of improving treatment options for those living with IBD. As we develop our commercial partnership model, we are tailoring our service offering to ensure that our model works for all parties, while maintaining the highest levels of data privacy, transparency and acceptability through our ongoing engagement with the IBD community. We actively encourage both applications and informal enquiries from SMEs either through our website, the HDR UK Innovation Gateway or directly via email gutreaction@eahsn.org.
