Dr Tim Jobson, Medical Director of Predictive Health Intelligence and Consultant Gastroenterologist at Somerset NHS Foundation Trust (Credit: Somerset NHS FT)
Almost 1,000 participants have been recruited to a liver disease study in less than a year using real-world NHS data.
Approximately 80% of clinical trials fail to meet their initial recruitment goals within specified timeframes, resulting in downstream costs for sponsors, delaying regulatory milestones, and slowing the delivery of new diagnostics and therapies.
He LiveWell Study was created to evaluate a new approach to identifying people at risk for metabolic liver disease using hepatoSIGHT case finding software from Predictive health intelligence (PHI) to identify and stratify people using historical blood test data across NHS systems.
It is being implemented in partnership with Somerset NHS Foundation Trust, which supported clinical supervision and carrying out research. Health Tawazun who does ultrasound tests of the liver, Healthy Geneticsand Innovate UK.
Dr Tim Jobson, PHI medical director and consultant gastroenterologist at Somerset NHS Foundation Trust, said: “One of the central challenges in liver disease is identifying suitable patients early enough to intervene meaningfully.
“Many people have minor abnormalities in their blood tests, but determining who is really at risk, before it is too late, has traditionally been difficult.
“By combining longitudinal laboratory data with genetic risk, we can stratify patients much more intelligently.
“What LiveWell demonstrates is that this approach not only has clinical value but also creates a scalable way to identify and recruit appropriate research participants.”
The new approach demonstrates that it is possible to enroll large numbers of participants within deadlines with the right data, risk analysis and partnerships.
Potentially eligible participants were invited via targeted emails, then screened and enrolled through the Sano Genetics platform, which enables electronic consent, at-home genetic testing, FibroScan appointment booking, and integrated data capture.
Recruitment and participation performance highlights included 1,300 unique visitors to the study home page, a 95% participation rate, a 76% sign-up conversion rate, and 996 participants enrolled in the study, of whom more than 99% requested a genetic test.
Patrick Short, CEO and co-founder of Healthy Geneticssaid: “This study demonstrates how rich longitudinal healthcare data sets can be translated into accurate case finding for genetic medicine trials.
“By combining secure data access with a supported remote contact, consent and testing framework, we enable systematic identification and engagement of eligible patients.
“This is an exciting demonstration of a scalable model to accelerate access to innovative therapies and trials.”
Using longitudinal genetic and blood test data, LiveWell aims to help researchers better identify suitable people earlier, supporting more targeted screening and long-term follow-up.
Participants are invited to provide a saliva sample for genetic testing and attend a non-invasive ultrasound-based FibroScan assessment to assess their liver health risk.
The study is ongoing, with genotyping and FibroScan evaluations, and initial results are expected later this year.
