At the same time, the value of NHS data is starting to be realised. One report last year found that in terms of operational savings, better patient outcomes and wider economic benefits, leveraging the NHS’ data could produce an impact of £9.6bn. The situation was put more starkly in a February 2020 report from Imperial College London. It said that, as society struggles with the twin challenges of an ageing population and the rising costs of new, innovative medical treatments, the NHS’ unique long-term health data assets would be transformative for health. “Ensuring that we maximise the benefits of this opportunity is non-negotiable,” warned the report’s authors, among them consultant surgeon Lord Ara Darzi and Lord James O’Shaughnessy, a former health minister.
It’s a clear direction, and yet, as anyone who works with large datasets will know, easier said than done.
James Anderson, a senior principal at IQVIA, notes: “Even the best, greatest real-world data is still not perfect. Data is missing, and you may find that some clinical teams are much more robust than others in the way that they retain and organise information within the medical records.
“Often there isn’t the data that we need to answer research questions in the place that we need it. We may need to go back through individual notes manually, perhaps finding text that’s in an unstructured form. For example, a pathology result or hospital letter saying the patient smokes, but that smoking status wasn’t entered into the database. So there is a process of data curation, to make sure that all the data required, whether in a structured or unstructured format, is noted and organised within the structured data of the electronic medical record, with the data then de-identified for analysis.” But the requirements for structured and unstructured data often depend on the level of intricacy for a particular piece of work, with more complicated analyses often requiring additional understanding – for example, results of a particular genomic test – that can be combined with electronic medical records.
Meanwhile, information governance and transparency of operations, and having them aligned with hospitals’ research oversight committee as well as national and international regulations, such as GDPR and the July 2019 DHSC Framework for the Value of NHS Research, need to be taken very seriously. As James says: “Effective governance is not something that happens overnight. It takes time to build up trust and there’s a journey to follow to demonstrate just how seriously data privacy and security are taken, as well as demonstrating a track record of compliant and appropriate behaviours. It also requires privacy-enhancing technologies and safeguards to protect individual privacy while generating insights that help healthcare stakeholders identify disease patterns and correlations with the best treatment pathway.”
Explaining what is expected from his institution, Professor Geoff Hall, a medical oncologist and chief clinical information officer at Leeds Teaching Hospital NHS Trust, explains how de-identified, patient-level data never leaves the organisation without the explicit consent of patients. “Analysis of anonymised data is performed within secure areas within the Trust and limited to individuals with contracts that bind them to the strict information governance standards of the hospital.”
Situated in the north of England, Leeds Teaching Hospitals NHS Trust is one of the largest Trusts in the country, covering a local population of almost one million and a regional population of 2.7 million for whom it provides specialised services. It is also one of the largest integrated cancer centres in Europe and leader in collecting detailed oncology data thanks to a system that holds records on more than four million patients and detailed data on more than 300,000 patients with cancer.
Avoiding many of the problems typically associated with large healthcare IT projects, the Trust continues to successfully design and build its own, electronic health record known as PPM+. In doing so, it began collecting and collating relevant and robust data that now provides a new, innovative source of real-world data to help researchers better understand the care cancer patients receive in multiple ways, including through a new collaboration with IQVIA.
James explains: “REAL Oncology facilitates access to the insights from Leeds’s real-world data, while protecting patients’ anonymity in a way that supports compliance with information governance, GDPR and the DHSC Framework for the Value of NHS Research.”
Geoff adds: “The collaboration we have developed allows the Trust to work with IQVIA in a way that protects the privacy of our patients’ information, but enables us to allow IQVIA analysts to extend the capabilities of the in-house team who analyse our local data.”
In practice, this means there’s an IQVIA team on the ground in Leeds and the collaboration is overseen and sits within the hospital’s own governance hierarchy for research, with full transparency about what the team is doing. James says: “The team comprises data scientists, a project manager, a medical writer and an oncologist for the clinical engagement and interpretation of the results. They’re really the engine for what REAL Oncology does and they’re embedded within the hospital and its wider research infrastructure.”
Moreover, there are a series of strict conditions in place for the collaboration. The REAL Oncology team will not generate work for the exclusive use of an individual commercial organisation, with any report generated placed in the public domain – ideally within a peer reviewed journal, with each project based on a master contract between the Trust and IQVIA. “In addition, the IQVIA-funded analysts divide their time between projects determined by IQVIA and those defined by the Trust to ensure fair value is delivered to the Trust and the patients it cares for,” says Geoff.
Analytic outputs from any of its projects all have to be reviewed and approved for information governance by the Trust before anything is allowed to pass outside the NHS firewall. Having all of these arrangements in place makes the REAL Oncology collaboration a practical demonstration of how an NHS organisation, academia and industry can work together on patient data to improve patient outcomes.
“My view,” says Geoff, “is that when you give clinical teams a better understanding of the care they deliver and the results they achieve, it allows them to provide better care to patients. That is certainly what drives me and motivates me.” Sometimes these improvements can come just by giving clinicians insights into the outcomes they achieve. Other times, detailed curation of datasets is needed to facilitate the additional analyses required to provide the insight. Geoff says: “At the clinician level, I have not yet met an oncologist who doesn’t want to see an analysis of their data. It’s a very research-focused specialty.”
Consequently, there are further benefits for the Trust in terms of its own reputation and opportunities for its clinicians to present research. James says: “These data will also be able to help, at the patient level, to rapidly screen people against trial inclusion and exclusion criteria – so that it’s quicker to identify the right patients for the right trials. And there’s a clear aspiration that we will be able to involve more patients in clinical trials – giving them access to the most innovative and novel medicines.”
Jacqui Gath, a cancer survivor and advocate, provides some additional thoughts on what matters to patients. She says: “Real-world evidence studies reveal the real effect of medications and procedures on the people taking them. These effects may be beneficial as intended, or not. People will forget to take their medicines, or they may not take them as indicated, or the drug may be a generic which does not have the same bio-availability as the original.
“Drug studies do not routinely disaggregate results by biological sex, despite FDA requirements, yet for example, women have different symptoms of heart attack and different responses to drugs. This big data approach may be able to show different effects of medications in men versus women. We already know that harm can be caused by assuming one size will fit all so having separate insights by sex is critical.”
Together, these benefits for the NHS, patients and clinicians should ensure that treatment advances are made available more quickly to those in need.
Studies to date from REAL Oncology have variously examined changes in lung cancer outcomes over the last 15 years, healthcare resource utilisation for bladder cancer, and treatment patterns for different stages and grades of lung cancer.
James says: “Beyond these interesting insights, some of the outputs from Leeds have helped submissions to health technology assessment bodies by providing robust data from the real world to strengthen cost models. We also know that the findings from the real-world studies in Leeds have helped either confirm or even inform changes to clinical trial design, making sure that researchers have got the right sub-populations in clinical trials so that they actually reflect practice in the real world.”
The hope with REAL Oncology is that more can be learned from cases of cancer in the UK to improve patient health. Looking at the present-day place for the work, Geoff says: “We will never replace a randomised controlled trial, but I see REAL Oncology as a highly complementary additional source of information, with real-world evidence enhancing the insights derived from clinical trials.”
As REAL Oncology has developed and grown, Leeds Teaching Hospital has been considering how it can get involved in national and international programmes to drive patients’ health improvements through clinical data. Leeds Teaching Hospitals NHS Trust is a founding member of DATA-CAN, the Health Data Research Hub for Cancer, which supports researchers to access anonymised patient data, and whose other founding members are UCLPartners, the University of Leeds, Queen’s University Belfast, Genomics England and IQVIA.
The collaboration is one of the seven HDR UK hubs set up to speed up research for new medicines and treatments, working in partnership with patients and the public.
It’s a perspective that resonates with cancer survivor and patient advocate Jacqui Gath. “Patients want the best possible treatment and care and are usually more than happy to donate their data if that data can help them get that for all. For that to happen it’s critical to engage with them in a trusted and a sustainable manner.”
Jacqui Gath, PPI patient advocate
Jacqui started out as a metallurgist and moved into information technology as a second career when she realised its potential. Her interest in health topics became very personal after a diagnosis of cancer in 2003 and since then she has been actively engaged in many cancer research studies, and joined an ethics committee and funding panel. Her particular interests lie in nutrition, genetics, and the interplay between the two and she is also involved in the DATA-CAN hub.
Professor Geoff Hall, medical oncologist, chief clinical information officer (CCIO), Leeds Teaching Hospital Trust and Professor of Digital Health and Cancer Medicine, University of Leeds
As a medical oncologist, he treats women with gynaecological cancer. As the CCIO for Leeds Teaching Hospitals NHS Trust, he provides clinical leadership to the wider informatics strategy at the Trust including the development and delivery of PPM+, the Trust-wide electronic patient record and the Leeds Care Record, the integrated digital care record for all health and social care providers for all Leeds patients. He also serves as clinical lead for DATA-CAN, the HDR UK hub for cancer.
James Anderson, senior principal, IQVIA
James has worked at IQVIA for over three years, overseeing large real-world data projects globally, and is the IQVIA lead for REAL Oncology. Previously he worked in the NHS as an operational manager, and a managing director for an academic health science partnership (Anglia Ruskin Health Partners).