How does hepatoSIGHT® improve clinical trial recruitment for liver disease?
Recruitment to liver disease clinical trials remains one of the biggest barriers to progress.
Despite the growing burden of liver disease and the large number of studies, finding eligible participants remains a major challenge. But why?
Why do liver disease trials struggle to recruit?
Liver disease is often silent, with many people not experiencing specific symptoms until the condition is advanced.
Without routine screening, large numbers of individuals remain undiagnosed and untreated, especially those in the early and intermediate stages of disease. This is precisely the group where emerging treatments could have the greatest impact. However, they are also the least likely to enrol in trials, partly because they do not know they have the condition, and partly because they are very unlikely to be under the care of a specialist.
There are limited, standardised diagnostic approaches to general population screening, making case identification complex, and strict inclusion and exclusion criteria lead to high screen failure rates.
For less common liver diseases, the pool of eligible participants is small, and new diagnoses often trickle intro clinics slowly. Add to that, the number of sites experienced in clinical research is finite, the growing competition between trials, timely recruitment becomes even harder.
Why does traditional feasibility fail?
Many liver disease studies rely on patients who are already visible within the health system: those with a coded diagnosis, those already under specialist care, or those known to individual clinicians.
This can create a distorted view of the available patient population.
Feasibility assessments may be based on historic recruitment figures, clinician estimates, or diagnosed cohorts. However, in liver disease, many potentially eligible patients are not yet diagnosed or are not currently being managed within specialist pathways.
As a result, sites may appear to have fewer suitable patients than they really do. Protocols may be designed without a clear view of the real-world population. Recruitment projections may be overly optimistic or overly cautious. Screen failure rates may also increase when eligibility criteria do not reflect the patients who actually exist within the health system.
How does hepatoSIGHT support sponsors and CROs?
hepatoSIGHT can support clinical trial recruitment before a study opens, and during active recruitment.
Trial-specific inclusion and exclusion criteria can be translated into a case-finding approach, allowing expected patient numbers to be modelled across participating sites, subject to the appropriate approvals and local governance.
This can help sponsors and CROs understand whether a protocol is realistic in the real world. It can also support site selection by showing where potentially eligible patients are most likely to be found.
Real-world data analysis can support:
- feasibility assessment based on routine health data, rather than estimates alone
- site selection using a more realistic view of available patient populations
- protocol simulation to understand how criteria affect the eligible cohort
- pre-screening workflows that help sites identify patients likely to be suitable for review
- recruitment planning that reduces reliance on already-diagnosed or pathway-visible cohorts
This approach can help reduce screen failure rates, accelerate recruitment timelines, and support more equitable participation by identifying patients who may not currently be visible through traditional recruitment routes.
Improving recruitment is not only a commercial priority for sponsors. It also gives more patients the opportunity to access research, specialist assessment and closer follow-up, while helping generate evidence that better reflects real-world liver disease populations.
How does hepatoSIGHT® support recruitment?
By analysing historic blood test results at scale, including longitudinal blood test results and demographic information, hepatoSIGHT enables research teams to identify people who may have undiagnosed early or intermediate liver disease and could be suitable for further clinical review or trial screening.
This means recruitment does not have to rely only on patients who are already diagnosed, referred, or on a clinical pathway.
hepatoSIGHT can help research teams identify potentially eligible patients earlier, support more targeted outreach, and build a broader picture of the recruitable population. This can support improved recruitment workflows, more representative cohorts, and ultimately, stronger and more impactful liver disease research.
Trials conducted at hepatoSIGHT-enabled sites can integrate this approach into their recruitment workflows. Patients who may be suitable can be identified for review by the site care team and, where appropriate, invited to discuss participation in a study.
This ensures that patient contact remains clinically led, while helping research teams find people who may otherwise be missed.
Can case-finding be scaled to support clinical trial recruitment pipelines?
Data-driven case-finding is an effective approach to identify eligible cohorts for clinical trials, but there are many aspects which affect how it scales across multi-site trials.
Any recruitment approach that aims to scale across multi-site trials must have a robust infrastructure. It should enable users from each site to access relevant patient information appropriately, while also allowing central oversight of enrolment criteria and recruitment performance.
Central to a data-driven approach are the regulatory, ethical, and compliance frameworks that ensure data sharing is underpinned by appropriate approvals and governance structures. This enables safe and effective use of data while protecting patients and supporting clinical oversight.
Systems that can scale are those that require minimal training, encourage clinician engagement and do not increase resource demands to deliver the trial.
Any system or approach being brought into clinical trials needs to demonstrate return on investment. Each trial defines a target recruitment rate for each site, and a data-driven case-finding approach must not only help meet this target but also deliver improvements over traditional workflows.
That means saving time, improving precision in identifying eligible cases, reducing screen failure rates, and ideally, increasing diversity and representativeness within cohorts.
For metabolic and liver disease trials, this is where hepatoSIGHT can make a meaningful difference: helping sponsors, CROs and clinical sites move beyond the visible diagnosed population and towards a more accurate understanding of real-world recruitment potential.
hepatoSIGHT is already delivering accelerated clinical trials, our recent paper on the LiveWell study recruitment explains how we can help.