ISCF HDRUK DIH Sprint Exemplar: Using Routine NHS Data to Accelerate Clinical Trial Recruitment

Every NHS hospital keeps a detailed record of activities both for the purposes of individual patient care and to ensure that the hospital is properly paid for the work that it does. A monthly report of activity, described in terms of ‘hospital episodes’ is sent to NHS Digital, who host the data in trust for the nation. Large-scale, randomised clinical trials allow us to establish whether or not a particular treatment works and whether it is safe. This knowledge is invaluable: without it, hospitals might be reluctant to adopt some new, life-saving innovation, 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 fashion.
This project will develop a system that uses the ‘hospital episodes’ information to identify potentially suitable patients from across the country so that they could be asked if they wished to take part in clinical trials. Previous studies have demonstrated that such an approach can be very successful in recruiting large numbers of patient volunteers to join major clinical research studies.

This project will deliver a secure, web-based service that uses data assets managed by NHS Digital to facilitate recruitment into large clinical trials and other research projects. There will be two components:
a) A metadata catalogue to facilitate use of HES data adapted from the NIHR Oxford Biomedical Research Centre catalogue toolkit. This will support annotation and
computable representation of source data, trial eligibility criteria, and data extraction requests.
b) A web-enabled system to facilitate clinical trial recruitment based on the NWEH FARSITE system originally designed for primary care. This will allow authorised
users to configure eligibility selection criteria (e.g. age-range, diagnosis), filter search results (e.g. by hospital), and generate lists of eligible individuals.
The work will be co-designed by experts in clinical trial design, data engineering, information governance, and NHS Digital systems and data assets. The work will be
evaluated using contemporary and hypothetical trial protocols, and demonstrated to potential users, including industry representatives. The project is time-limited but will inform the design and implementation of future systems to facilitate data-enabled clinical trials, prospective cohorts, and precision medicine studies. It will also provide an important component for an upgraded NIHR Health Data Finder.