Breaking down barriers for patient data registries By Grace Melvin, Policy Officer, AMRC Published: Wednesday 7 August 2019 As rich sources of patient data, registries hold the promise of huge benefits to patients. As yet however, their full potential is not being realised. A workshop held by AMRC and the Office for Life Sciences in June 2019 examined the challenges holding them back and the actions that the Government and NHS could take to unlock their potential. Why do registries matter? Patient data registries hold large collections of patient data in a central hub and tend to be disease specific. Over 30 AMRC members hold data registries to improve the lives of patients - from gathering simple but vital information on the true number of people with a rare condition, to monitoring a drug’s long-term safety and efficacy in pharmacovigilance studies. Unlocking the potential of registries The opportunity to unlock the power of registries is significant. AMRC’s registries report, published in November 2018, highlighted the innovative ways registries are being used for patient benefit across the sector. There is now both a need and an opportunity to tackle some of the challenges constraining their success. The workshop pinpointed four main challenges and generated some practical steps that could help overcome these. 1) Interoperability is key Interoperability is a buzz word within the patient data community. But how can we achieve true interoperability? We learn about interoperability from a young age: Lego is as interoperable as it comes. Whether you want to build your Lego house or spaceship, the bricks click together and off you go. As Jackie Shears from NHS Digital described at the workshop, unfortunately, achieving the same objective with patient data hasn’t proved to be child’s play. For data to be easily linked together for patient benefit, we need to store it in a universal format, to the same standards. But currently, we don’t know what Lego bricks we have, or who has which pieces. What’s more, some of us have Lego, some have Duplo, and some have stickle bricks. Herein lies the problem. We need data to be visible and shareable if we want to achieve interoperability. The importance of interoperability becomes clearer when we consider multi-morbidities. Up to 30% of people in England are estimated to have two or more long-term conditions and figures are predicted to rise in the years ahead. Siloed use of data cannot answer research questions that span multiple disease areas - sharing and collaborating with interoperable data is crucial. 2) We need faster, easier access to data Quick access to data continues to be a challenge for registries trying to link their data with national datasets. Data controllers like NHS Digital and Public Health England aim to get an application for data access approved within 60 days, but it has been known to take significantly longer. Though ‘risk-averse processes’ intend to protect patient interests, the evolved system inadvertently delays patients from benefiting from registries, undermining the intended purpose. Efforts to reduce the time it takes to approve data requests are key and will enable organisations to divert time and resource back to research priorities themselves. 3) The data landscape can be confusing Even for an experienced user, navigating the data landscape can be fraught. Registries must access multiple datasets, hence interface numerous data controllers, each with their own procedures and requirements that vary across the UK. To the outsider, it can seem impenetrable. For registries to be a success, we urgently need a more streamlined process: a better understanding of who holds which datasets, and a consolidation of the number of bodies holding data. 4) Ethical approval remains a barrier Securing ethical approvals and consent – often across multiple sites – is a regularly cited obstacle. This is compounded by the Health Research Authority (HRA)’s decision-making process sometimes showing inconsistency. For example, the HRA not viewing all registries as equal in terms of consent models. Deeper engagement between the HRA and registry teams will help them better understand each other’s demands and iron out discrepancies. What next? The challenges described above affect not only the registry community, but all parties who access and use patient data. We can’t work alone on these issues: achieving any substantial progress will require sector-wide and collaborative effort. The good news is that strides in this direction are already being made. NHS Digital’s Research Advisory Group focuses on tackling the structural barriers to accessing NHS data. Health Data Research UK has ambitious plans to make data more available for research through its Health Data Research Alliance, Innovation Gateway and Digital Innovation Hubs. And NHSX has made clear that its core mission must be underpinned by data and standards. The AMRC, in this busy environment, continues to ensure that charities are represented in larger discussions about data. Following the registries workshop, AMRC and the Office for Life Sciences plan to establish a small Working Group with key stakeholders to focus on three main priority areas: data access; data standards and interoperability; and ethics and consent. We are in the planning stages and updates will be made as progress is made. Registries face challenges but significant opportunities. Whilst there are barriers to overcome, there are also encouraging developments, with leading organisations beginning to work together to ensure it is easier to unlock the invaluable resource of patient data registries.