Large-scale, randomised clinical trials allow researchers to establish whether a particular treatment works and whether it is safe. Without them, hospitals might be reluctant to adopt new, life-saving innovations, or a new, more effective medicine might remain unproven and unused. However, clinical trials can be very expensive to conduct and many fail to recruit sufficient numbers of patients to allow them to provide a conclusive answer, in a timely manner.
A system utilising routine NHS data, designed by University of Oxford, will enable researchers to work with the NHS and industry to accelerate recruitment into clinical trials, increase the opportunities for NHS patients to participate in research, and provide answers to important research questions more rapidly.
Every NHS hospital keeps a detailed record of activities both for the purposes of individual patients and to ensure that the hospital is paid for the work that it does. A monthly report of these activities, described in terms of ‘hospital episodes’ is sent to NHS Digital, who host the data in trust for the nation. The team worked with NorthWest EHealth (NWEH), a clinical trial platform, that has the technology to utilise routinely collected healthcare data to support clinical trial feasibility and recruitment processes, while preserving the confidentiality of individuals.
They collaborated to develop a system that uses the ‘hospital episodes’ information to identify potentially suitable patients from across the country who could be asked if they wish to take part in clinical trials.
They developed this by observing a trial that is looking to recruit 15,000 patients in the UK, aged 55 and over, with vascular disease. To understand whether it is feasible to recruit such a large number of patients in the UK, data were produced manually by NHS Digital. This takes time and staff resource and understanding a patient’s journey through the healthcare system can be complex. Crude data of potentially eligible patients does not take into account different locations they have had treatment or indicate the number of potentially eligible patients living near to the hospital site or how best to approach them.
The team recognised that an automated search tool could identify outpatients at a hospital, patients living nearby, and ensure their qualifying history had happened in a specific timeframe. The output of this collaboration between NHS Digital, University of Oxford, and NWEH was a system accessible over a secure internet connection to appropriate users where the study protocol was entered, run, and search results exported to NHS Digital in a process which took just under three weeks versus the original process taking many months.
The ‘hospital episodes’ data, collected by NHS Digital from every trust in the country, is combined to create a large national dataset. This provides detailed data about every hospital admission, A & E attendance, and outpatient appointment at NHS hospitals in England. Then this data, which has been anonymised, can be made available to researchers, who may apply analysis to the data directly, or combine it with other data sources to enrich the data they currently hold. This will simplify the process of preparing an extract for scientific analysis, reduce costs, and could lead on to more successful research.
The project has enabled a simpler, quicker process for identifying and inviting eligible patients onto clinical trials and allowed the re-use of clinical data in scientific research.
Partners: NIHR Oxford Biomedical Research Centre, University of Oxford Big Data Institute, NHS Digital, North West Ehealth Ltd, Aire Logic Ltd
NHS DigiTrials – Our Hub for Clinical Trials
NHS DigiTrials focusses on the development of a foundation service to improve the assessment of clinical trial feasibility - supporting improved planning and delivery of clinical trials in the UK.
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