Properly managed use of electronic patient data under the government’s National Programme for IT in the National Health Service would have “enormous” benefits for all types of clinical, public health and health services research, as well as for many aspects of patient care, says the UK Clinical Research Collaboration.

Nonetheless, a number of key data, regulatory and governance issues need to be addressed before this potential can be realised, the UKCRC notes. There is also a public relations battle to be won, it adds, calling for “formal recognition that research is a core, not secondary, component of the development of the NHS Care Records” and a communications strategy to convince stakeholders of the dual benefits of using electronic patient records (EPR) for both research and clinical care.

The pharmaceutical industry has set great store by the National Programme for IT, seeing potential access to some 52 million EPRs as a unique selling proposition that could help to restore the UK as a hub of clinical research and check the drift of clinical trials to lower-cost markets such as Russia, India or China.

Industry sceptical

However, industry has been sceptical about the ability of the programme’s Secondary Uses Service (SUS) to deliver on these goals. The SUS was established by the much-maligned NHS Connecting for Health agency to provide pseudonymised, patient-based data and information through the NHS Care Records Service (NHS CRS) for management and clinical purposes other than direct patient care.

Industry’s concerns were borne out by the findings of a simulation conducted by the UKCRC to explore the capability of the NHS CRS infrastructure to support clinical trials. The simulation team, including representatives from GlaxoSmithKline, Johnson & Johnson and the Medicines and Healthcare products Regulatory Agency, said it did not “expect a solution solely based on SUS to be the best way forward, but that hybrid approaches should be explored and pursued.”

These could be “either a confederation of local integrated databases and capabilities, or a federation of national datasets and capabilities (or a mixture of both),” the report suggested.

Four simulations

The clinical trials simulation was one of four commissioned in October 2006 by the UKCRC’s Research and Development Advisory Group to Connecting for Health, and sponsored by the Department of Health’s Director-General of R&D and Director of IT Services.

The other three simulations looked at a pharmacovigilance and disease surveillance system based on the NHS CRS; prospective tracking of a known cohort by UK Biobank, the £61-million project to determine how human genes, lifestyle and the environment interact in the development of conditions such as cancer, heart disease and diabetes; and applications in retrospective observational epidemiological studies.

The R&D Advisory Group to Connecting for Health has now issued a detailed report on the outcomes of these simulations, as well as recommendations for taking the NHS CRS forward to the benefit of research, patients and public health.

In the context of clinical development, access to data from national electronic patient records would offer a number of advantages at the planning stage (eg. through accurate feasibility assessment), in patient recruitment (identifying potential enrollees), for fast, efficient and accurate data collection, and in the post-trial phase (extension studies, safety studies, post-marketing commitments).

Issues highlighted

Among the issues highlighted by the clinical trials simulation team were:

- The need for access to comprehensive patient data, covering as wide a population across the UK as possible, to “open up a broad subject pool and a representative population for trial planning and modelling.”

- Data would have to span all care settings and services, including both up-to-date and legacy data, “to give a rich picture of patients’ health and care.” Also crucial were high-quality input to ensure data accuracy and linkage at the individual patient level.

- Access to data must be strictly governed, although it was “critical” that researchers had access to patient-level data, the team insisted. Anonymised data would be suitable for a number of activities, including trial planning, while an “appropriate, governed mechanism” could be set up to enable access to patient-identifiable information for recruitment purposes.

- Supporting systems should include standards for recording, processing and transferring data; a validated environment for those data; and specific processes and tools for clinical research.

- A “first-class capability” for supplying data and associated services from a federation of data sources was required, “whether it is an enhanced SUS or a new development of infrastructure."

A new organisation

These prerequisites called for an organisation with the capacity to “manage the design and delivery of the required infrastructure, and then to provide the ongoing linkage and research support services,” the team commented.

“In order for this organisation to successfully create and deliver the environment for clinical trials research alongside the concurrent development of other aspects of the National Programmes for IT”, it added, “its direction, strategy and resourcing will need to be endorsed at the highest level of NHS Connecting for Health.”

There was strong consensus from all four simulation teams on the following points:

- Clinical services and research shared the same mission of improving patient care and safety.

- Research made a key contribution to assessing the completeness and quality of data used for clinical care and health services.

- Leadership was needed to create the necessary sustainable infrastructure to exploit the research opportunities afforded by routine patient and other data.

- Solutions should be addressed from a UK-wide perspective, building on the extensive experience with record linkage already in place.

- Although much of the research would concern patient groups and hence would call for anonymised data, the data would also need to be linked and comprehensive at the individual patient level to ensure “maximal value and to allow quality and completeness to be validated.”

- The breadth of data required suggested “a concept of a data switchboard with potential to link NHS Care Records widely to other data sources, rather than as a single data warehouse.”

- A federated structure of data sources, as opposed to a single ‘warehouse’, would also provide an infrastructure with optimal governance systems.

- Linkage of data from the Secondary Uses Service with primary care and pathology service data was “a matter of priority.”

The report’s recommendations were backed by Lord Hunt, UK Minister of State for Quality at the Department of Health. He has asked the Director-General of R&D and Director of IT Services to work together on an action plan to take the recommendations forward “in the context of other developments in e-Health, and in tandem with measures to strengthen the good governance of health information used for wider purposes.”